appendix iv eligibility checklist
subject information inclusion/exclusion criteria

Inclusion Criteria (From IRB approved protocol) Yes No **Supporting Documentation***  
| Subject Name: ______________________________________________ Study ID: ____________________________________ Gender: Male Female   |
|-----------------------------------------------------------------------------------------------------------------------------------|  
| 1.                                                                                                                   | Histologically confirmed adenocarcinoma of the  pancreas                                                                                                                                                                                                                                           |
|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2.                                                                                                                   | Induction mFOLFIRINOX up to 4 cycles                                                                                                                                                                                                                                                               |
| 3.                                                                                                                   | Stable or better disease on re-staging                                                                                                                                                                                                                                                             |
| scans                                                                                                                |                                                                                                                                                                                                                                                                                                    |
| 4.                                                                                                                   | Deter                                                                                                                                                                                                                                                                                              |
| mined unresectable by a pancreatic cancer surgeon or a  multi-disciplinary or gastrointestinal oncology Tumor  Board |                                                                                                                                                                                                                                                                                                    |
| 5.                                                                                                                   | Typically, pancreatic tumors must be < 8.0 cm in  greatest axial dimension at time of treatment planning  but final determination of eligibility will be based upon  satisfying the radiation normal tissue constraints as  specified in protocol (Section 6.1.3 - Radiation  Treatment Planning). |
| 6.                                                                                                                   | ECOG 0, 1, or 2                                                                                                                                                                                                                                                                                    |  
| 7.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | Acceptable organ and                                                                   |     |    |                           |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|-----|----|---------------------------|
| marrow function as defined below and within 30 days  of eligibility confirmation: a. Leukocytes >3,000/µL b. ANC >1,500µL c. Platelets >50,000/µL  d. Total bilirubin <1.5 X institutional upper limits of normal e. AST (SGOT)/ALT (SGPT) <2.5 X institutional  upper limit of normal f. Creatinine not above the upper limit of normal  institutional limits                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     |                                                                                        |     |    |                           |
| 8.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | Ability to understand and the willingness to sign a  written informed consent document |     |    |                           |
| 9.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | Life expectancy >6 months Exclusion Criteria (From IRB approved protocol)              | Yes | No | Supporting Documentation* |
| 1. Children / Age <18 years 2. Metastatic disease 3. Prior radiotherapy to the upper abdomen/liver 4. Prior chemotherapy for pancreatic cancer, other than up  to 4 cycles of mFOLFIRINOX 5. Uncontrolled illness including, but not limited to,  ongoing or active infection (or infections requiring  systemic antibiotic treatment), symptomatic congestive  heart failure, unstable angina pectoris, cardiac  arrhythmia, or psychiatric illness/social situations that  would limit compliance with study requirements. 6. Any concurrent malignancy other than non-melanoma  skin cancer, non-invasive bladder cancer, or carcinoma in  situ of the cervix. Patients with a previous malignancy  without evidence of disease for > 5 years will be allowed  to enter the trial. 7. Pregnant and breastfeeding women are excluded, as well  as women of child-bearing potential who are unwilling or  unable to use an acceptable method of birth control  (hormonal or barrier method of birth control; abstinence)  to avoid pregnancy for the duration of the study. Male  subjects must also agree to use effective contraception for  the same period as above.  8. Women who are not post-menopausal (as defined in  Appendix III) and have a positive urine or serum  pregnancy test or refuse to take a pregnancy test *Supporting documentation is required to confirm subject eligibility and can include but is not limited to: clinic  notes, laboratory results, pathology results, radiology reports, subject self-report, or MD documentation. |                                                                                        |     |    |                           |
appendix iv eligibility checklist
iv. statement of eligibility

By signing this form of this trial I verify that this subject is [ eligible / **ineligible**] for participation in the study. This study is approved by the Stanford Cancer Institute Scientific Review Committee, the Stanford IRB, and has finalized financial and contractual agreements as required by Stanford School of Medicine's Research Management Group.  
| Study Coordinator Signature:                 | Date:   |
|----------------------------------------------|---------|
| Printed Name:  Secondary Reviewer Signature: | Date:   |
| Printed Name:  Treating Physician Signature: | Date:   |
| Printed Name:                                |         |
appendix v case report form
iv. statement of eligibility

Case Report Form for SAEs, AEs, **and UPs**
**Subject Log**
**Protocol Deviation Log**
AE (Adverse Event) Tracking Form
case report form for saes
iv. statement of eligibility

Page 77 of 84 Received On:_____________
Date Submitted to CCTO:_____________
Date Submitted to SUMC IRB:_____________
Protocol: **Pancreatic Cancer Radiotherapy Study Group (PanCRS) Trial:**  
  
A Randomized Phase III Study Evaluating Modified FOLFIRINOX (mFFX) with or without Stereotactic Body Radiotherapy (SBRT) in the Treatment of Locally Advanced Pancreatic Cancer Stanford eprotocol \#:__27492__ OnCore \#:__PANC0015_
Date of Report: __________________ Participating Site and Location:_____________________________________________________ Date of Event:________________________ Subject's Initials: _____________________ Subject's OnCore \#:___________________ Research Staff Completing Form:
Name: ________________________________________ Phone: ________________________________________ Email: ________________________________________
Principal Investigator / Treating Physician at study site has reviewed and agrees with information in this report: Printed Name: _______________________________________ Signature: ___________________________________________ Date: _________________
case report form for saes
answer all questions below. provide

1. Check if event was: Serious Adverse Event (SAE)* Adverse Event (AE)* Unanticipated Problem (UP)\#
*Note Grade: _ (According to CTCAE, V 4 or greater, available at http://ctep.cancer.gov/reporting/ctc.html.) \#If also UP, check that it meets criteria for: Unexpected Related Harmful 2. Check the box of which therapy the event was related or possibly related to:
mFOLFIRINOX SBRT Other, indicate: __________________________  
3. Indicate how much treatment the subject received up to the event:
- For mFOLFIRINOX, Cycles_______ and Days or Doses_______
- For SBRT, fractions______ and cGy_______
4. Provide a brief description of the event, including:
symptoms reported and when (dates) results of scans, labs, or other procedures or tests if hospital ED visit or admission, give dates and length of hospitalization If Grade 5, indicate date of death, primary cause, if death certificate obtained, and if autopsy performed  
5. Following the event:  
Was therapy discontinued? No Yes N/A  
Was dose modified? No Yes N/A  
If Yes, note modified dose(s): _____________________________________________________  
6. Define the action plan and follow-up, including:
Next visit and follow-up schedule if not per protocol Referrals for tests, procedures, specialty or other clinics Other pertinent information:
**Protocol:** Pancreatic Cancer Radiotherapy Study Group (PanCRS) Trial: A Randomized Phase III Study Evaluating Modified FOLFIRINOX (mFFX) with or without Stereotactic Body Radiotherapy (SBRT) in the Treatment of Locally Advanced Pancreatic Cancer Stanford eProtocol \#: 27492 OnCore \#: PANC0015 Participating Center: ___________________________________________  
  
| Subject Log                             |                                |                |               |
|-----------------------------------------|--------------------------------|----------------|---------------|
| Date On-Study  (Date of  Randomization) | Treatment  Start Date  (Day 1) |                |               |
| #                                       | Subject Name                   | Subject        | Subject ID or |
| Initials                                | OnCore #                       | Treatment  Arm | Date          |
| Off-Study                               | Reason Off-Study               |                |               |
| mFFX                                    |                                |                |               |
| 1                                       | +SBRT mFFX                     |                |               |
| 2                                       | +SBRT mFFX                     |                |               |
| 3                                       | +SBRT mFFX                     |                |               |
| 4                                       | +SBRT mFFX                     |                |               |
| 5                                       | +SBRT mFFX                     |                |               |
| 6                                       | +SBRT                          |                |               |  
| mFFX   |            |
|--------|------------|
| 7      | +SBRT mFFX |
| 8      | +SBRT mFFX |
| 9      | +SBRT      |
| 10     | mFFX +SBRT |  
Protocol: Pancreatic Cancer Radiotherapy Study Group (PanCRS)
Trial: A Randomized Phase III Study Evaluating Modified FOLFIRINOX (mFFX) with or without Stereotactic Body Radiotherapy (SBRT) in the Treatment of Locally Advanced Pancreatic Cancer Stanford eProtocol \#: 27492 OnCore \#: **PANC0015**
Participating Center: ___________________________________________  
| Protocol Deviation Log Code   | Date IRB          |              |                   |            |
|-------------------------------|-------------------|--------------|-------------------|------------|
| (see next                     | Brief Description | notified, if | Corrective Action |            |
| page)                         | applicable        |              |                   |            |
| Subject                       | Subject ID or     | Date of      | Category (see     |            |
| #                             | Initials          | OnCore #     | Deviation         | next page) |
| 1 2 3 4                       |                   |              |                   |            |  
| 5 6 7 8 9 10 11 12   |
|----------------------|
case report form for saes
deviation categories

A. Safety B. Informed Consent C. Eligibility D. Protocol Implementation E. Other, specify in log Deviation Codes (associated with Deviation categories)
case report form for saes
safety (category a)

1. Not reporting SAE within 24 hours 2. Laboratory tests not done 3. AE/SAE not reported to IRB
4. Other, specify on log
case report form for saes
informed consent (category b)

5. Failure to obtain informed consent 6. Consent form used was not current IRB approved version 7. Consent form does not include updates or information required by IRB
8. Consent form missing 9. Consent form not signed and dated by participant 10. Consent form does not contain all required signatures 11. Other, specify in log
case report form for saes
eligibility (category c)

12. Participant did not meet eligibility criteria 13. Randomization of an ineligible patient 14. Participant randomized prior to Baseline Assessment 15. Randomization or treatment of a patient prior to IRB approval of protocol 16. Other, specify in log
case report form for saes
protocol implementation (category d)

17. Failure to keep IRB approval up to date 18. Participant receives wrong treatment 19. Participant seen outside of window visit 20. Use of unallowable concomitant treatments 21. Prescribed dosing outside of protocol guidelines 22. Missed Assessment 23. Missed Visit 24. Other, specify in log  
| AE Tracking Form: PanCRS Trial - Phase III Rand mFFX w/ or w/o SBRT |Site:   | PI:                        |                       |            |            |            |
|------------------------------------------------------------------------------|----------------------------|-----------------------|------------|------------|------------|
| Pt Last Name:                                                                | Subject ID #:              | Inst. MRN:            | Page #:    |            |            |
| f/u visit  or                                                                | f/u visit  or              | _FFX- Cycle:          |            |            |            |
| f/u visit  or  _                                                             | f/u timept, if applicable: |                       |            |            |            |
| □ Oncore                                                                     | □ Oncore                   |                       |            |            |            |
| Date                                                                         | Date                       |                       |            |            |            |
| Hints for                                                                    | Gra Attribution*           | | Grad | Attribution* |            |            |            |
| A by system                                                                  | Lab                        | Lab                   |            |            |            |
| grading                                                                      | Results/                   | de                    | Results/   | e          |            |
| Comment                                                                      | Comment                    |                       |            |            |            |
| Date:                                                                        | FX SBRT                    | Date:                 | FX SBRT    |            |            |
| Blood/Bone                                                                   | Abnormals                  |                       |            |            |            |
| marrow                                                                       | oly                        |                       |            |            |            |
| low                                                                          |                            |                       |            |            |            |
| WBC                                                                          |                            |                       |            |            |            |
| Hgb                                                                          | low                        |                       |            |            |            |
| Hct                                                                          | low                        |                       |            |            |            |
| Platelets                                                                    | low                        |                       |            |            |            |
| Neut ABS/  ANC                                                               | low                        |                       |            |            |            |
| Lym ABS                                                                      | low                        |                       |            |            |            |
| Other-                                                                       |                            |                       |            |            |            |
| Metabolic Panel                                                              | Abnormals                  |                       |            |            |            |
| oly                                                                          |                            |                       |            |            |            |
| Sodium                                                                       |                            |                       |            |            |            |
| Potassium                                                                    |                            |                       |            |            |            |
| Chloride                                                                     |                            |                       |            |            |            |
| Creatinine                                                                   | high                       |                       |            |            |            |
| Glucose                                                                      |                            |                       |            |            |            |
| Calcium                                                                      |                            |                       |            |            |            |
| Bilirubin                                                                    |                            |                       |            |            |            |
| AST                                                                          |                            |                       |            |            |            |
| ALT                                                                          |                            |                       |            |            |            |
| Ak phos                                                                      |                            |                       |            |            |            |
| Albumin                                                                      | low                        |                       |            |            |            |
| Protein                                                                      |                            |                       |            |            |            |
| Other-                                                                       |                            |                       |            |            |            |
| Constitutional                                                               |                            |                       |            |            |            |
| Fatigue                                                                      | Affecting ADLs?            |                       |            |            |            |
| Weight loss                                                                  | < 5, 10 or 20%             |                       |            |            |            |
| from basline?                                                                |                            |                       |            |            |            |
| G                                                                            |                            |                       |            |            |            |
| Anorexia                                                                     |                            |                       |            |            |            |
| Nausea                                                                       | IVF needed?                |                       |            |            |            |
| Vomiting                                                                     | Episodes/d? IVF?           |                       |            |            |            |
| Diarrhea                                                                     | BMs/d? 2/2 tx or           |                       |            |            |            |
| malabsorption?                                                               |                            |                       |            |            |            |
| Constipation                                                                 | Last BM?                   |                       |            |            |            |
| Heartburn/dyspep                                                             | PPI daily?                 |                       |            |            |            |
| sia                                                                          |                            |                       |            |            |            |
| Upper bleed                                                                  | Procedure?                 |                       |            |            |            |
| Procedure?                                                                   |                            |                       |            |            |            |
| Lower bleed                                                                  | Symptoms?                  |                       |            |            |            |
| Ulcer                                                                        |                            |                       |            |            |            |
| Other                                                                        |                            |                       |            |            |            |
| Neurology                                                                    |                            |                       |            |            |            |
| Periph neuropathy Interfering w/ fxn?                                        |                            |                       |            |            |            |
| Pain                                                                         |                            |                       |            |            |            |
| Abdominal pain                                                               |                            |                       |            |            |            |
| Other location                                                               |                            |                       |            |            |            |
| Other                                                                        |                            |                       |            |            |            |
| Signature                                                                    | Inv signature / date:      | Inv signature / date: |            |            |            |
| * Attribution - Note # under FFX or SBRT column:                             | 1-unrelated                | 2-unlikely            | 3-possible | 4-probable | 5-definite |