Clinical trial NCT02128100: Effects of Folfirinox and Stereotactic Body Radiation Therapy for Advanced Pancreatic Cancer
Official title: The Effect of FOLFIRINOX and Stereotactic Body Radiation Therapy for Locally Advanced, Non-Resectable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer Non-resectable
Keywords: Pancreatic Cancer
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: James Graham Brown Cancer Center
First posted: 2014-05-01
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study wants to find out how safe and effective the use of Folfirinox combined with Stereotactic Body Radiation Therapy )(SBRT) is for the treatment of pancreatic cancer.

Detailed description: The study will be a prospective, non-randomized, single center, trial to assess the effects of FOLIRINOX chemotherapy with SBRT on locally advanced, non-resectable pancreatic cancer. Patients will either undergo a biopsy to confirm the diagnosis or have strong clinical suspicion of a new cancer or recurrence based on the recommendations of a multi-disciplinary GI oncology team. FOLFIRINOX with be delivered prior to SBRT for 4 cycles. Restaging imaging will occur prior to SBRT delivery. SBRT will be delivered using standard stereotactic techniques to a dose of 3200cGy at 650cGy per fraction delivered over 2 weeks. Additional adjuvant chemotherapy with be delivered at the physician's discretion. Patients will be reassessed both clinically and radiographically at 3 months, 6 months, 9 months and 12 months post-treatment. Quality of life analysis will occur at 3 month intervals after treatment. Blood will be drawn for exploratory biomarker analysis at strategic timepoints during treatment and followup. Following the initial imaging time points, standard surveillance will be employed with clinical assessment and imaging at 3 month intervals for the first 2 years post-treatment.

Eligibility criteria: Inclusion Criteria:

* Age \>/= 18 years
* ECOG performance status 0-1
* Pathologic or clinical diagnosis of a new pancreatic adenocarcinoma. A reasonable attempt should be made to make a pathologic diagnosis of malignancy.
* Imaging as follows:

  * CT scan of the chest, abdomen and pelvis with IV and oral contrast within 8 weeks of registration
  * Whole body PET scan within 8 weeks of registration
* Evaluation by a surgical oncologist to determine non-resectability
* Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential.
* CBC/differential obtained within 14 days prior to registration with adequate bone marrow function as follows:

  * ANC \> 1,500 cell/mm3
  * Platelets \> 100,000 cells/mm3
  * Hemoglobin \> 8.0 g/dl (transfusion to obtain this value is permissible)
* Additional labs within 14 days prior to registration

  * CA 19-9
  * Creatinine \<2mg/dl
  * Bilirubin \<2mg/dl
  * AST and ALT \< 2.5 x ULN
* Patients must provide study specific informed consent prior to study entry.

Exclusion Criteria:

* Metastatic disease as defined by the multi-disciplinary team
* Prior anti-cancer therapy for a pancreatic tumor
* Prior malignancy within the last 3 years.
* Pregnant women or lactating women
* Acquired Immune Deficiency Syndrome (AIDS) based on CDC criteria. However HIV testing is not manditory for this protocol
* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

Primary outcomes:
measure: Grade 3 or Higher Adverse Event(s) as a Measure of Safety and Tolerability
timeFrame: Assessed up to 24 months post treatment
Secondary outcomes:
measure: Overall Response Rate for Participants as Assessed by Contrast-enhanced CT Scan of the Abdomen at 12 Months.
timeFrame: Assessed at 3 months, 6 months, 9 months and 12 months post-treatment
Other outcomes:
measure: Quality of Life Assessment at 12 Months Post-treatment
timeFrame: 12 months from completion of therapy
Locations:
city: Louisville
country: United States
facility: James Graham Brown Cancer Center
state: Kentucky
Study officials:
affiliation: James Graham Brown Cancer Center
name: Neal E Dunlap, MD
role: PRINCIPAL_INVESTIGATOR
References: