Clinical trial: NCT03781323
Section: Confidentiality
Subsections: Confidentiality Of Records And Authorization To Use And Disclose Information For

Research Purposes The University of Rochester makes every effort to keep the information collected from you private. In order to do so, we will limit access of research information collected on this study to include only trained research personnel assigned to this study. Sometimes, however, researchers need to share information that may identify you with people that work for the University, regulators or the study sponsor.  
If you have never received a copy of the University of Rochester Medical Center (URMC)  
and Affiliates Notice of Privacy Practices, please ask the investigators for one.  
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What information may be used and given to others?

The study doctor will get your personal and medical information. For example:

Research records

Records about phone calls made as part of this research

Records about your study visits

Past and present medical records related to this study

Results of medical tests


Who may use and give out information to you?

The study doctor and study staff

URMC and Affiliates


Your information may be given to:

The University of Rochester, including the Institutional Review Board that oversees the

research.

Other University of Rochester physicians involved in your clinical care.

Federal and State agencies (such as the U.S. Food and Drug Administration (FDA),

the Department of Health and Human Services, the National Institutes of Health and

other United States agencies) or government agencies in other countries that oversee or

review research. They may also need to inspect study records at some point during

the study or even after it has been completed. In the event that this should occur,

every effort will be made to keep identifying information about you private.


Why will this information be used and/or given to others?

To do the research

To study the results

To see if the research was done right

If the results of this study are made public, information that identifies you will not be used.


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What if I decide not to give permission to use and give out my health information?  
Then you will not be able to be in this research study.  
Page 10 of 13  
RSRB\#: STUDY00003244 May I review or copy my information?  
Yes, but only after the research is over.  
How long will this permission be valid?  
This permission will last indefinitely.  
May I cancel my permission to use and disclose information?  
Yes. You may cancel your permission to use and disclose your health information at any time. You do this by sending written notice to the study doctor. Upon receiving the written notice, the study team will no longer use or disclose your health information and you will not be able to stay in this study. Information that has already been gathered may need to be used and given to others for the validity of the study.  
May I withdraw from the study?  
Yes. If you withdraw your permission to be in the study, no new health information identifying you will be gathered after that date. Information that has already been gathered may still be used and given to others.  
Is my health information protected after it has been given to others?  
No. There is a risk that your information will be given to others without your permission.
Clinical trial: NCT03781323
Section: Duration of Study Involvement
Subsections: Duration Of The Study:

The treatment portion of this study is expected to last up to 24 weeks. The monitoring portion of the study is expected to last 5 years.
Clinical trial: NCT03781323
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks Of Participation:|Risks And Complications Related To Change In Timing Of Chemotherapy, Radiation And Surgery:|Rare, And Serious|Possible Side Effects Of Short Course Radiation|Reproductive Risks:|General Considerations Regarding Other Risks:|Compensation For Injury

You may have side effects while on the study. Everyone taking part in the study will be watched carefully for any side effects. They may be mild or very serious. Your health care team may give you medicines to help lessen side effects. Many side effects go away soon after you stop receiving chemotherapy, but in some cases, they can be serious, long lasting, or may never go away.

The study is intended to eliminate the need for surgery. Even if this is not the case, getting chemotherapy first might reduce the tumor prior to surgery, and it might reduce the risk of recurrence. There is a risk with the study that by proceeding to chemotherapy first, if your cancer continues to grow it may be more difficult to remove or treat the tumor with radiation and surgery.  
There is also a risk that during surveillance after you have completed treatment, your cancer may return. If this is the case, you will need to be evaluated for surgery and/or radiation treatment.  
There is a risk that the tumor may return in a place more difficult for surgery, or metastasize to a place where it cannot be surgically resected and become incurable.  
The components of the treatments proposed in this study have known side effects that are listed below:  
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Possible Side Effects of FOLFOX (Leucovorin, 5Fluorouracil, Oxaliplatin)

COMMON, SOME MAY BE

SERIOUS

In 100 people receiving FOLFOX (Leucovorin, 5Fluorouracil, Oxaliplatin),

more than 20 and up to 100 may have:


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Hair loss Redness, pain or peeling of palms and soles Rash, increased risk of sunburn, itching Diarrhea, nausea, vomiting, constipation, loss of appetite Difficulty swallowing Sores in mouth Heartburn Infection, especially when white blood cell count is low Anemia which may require a blood transfusion Bruising, bleeding Headache Tiredness Numbness, tingling or pain, "pins and needles" of the hands, feet, arms and legs Tingling or a loss of feeling in your hands, feet, nose, or tightness in throat or jaw, or difficulty swallowing or breathing which may be made worse by exposure to cold Cough Fever, pain OCCASIONAL, SOME MAY BE SERIOUS  
In 100 people receiving FOLFOX (Leucovorin, 5Fluorouracil, Oxaliplatin), from 4 to 20 may have:  
Skin changes including dryness, redness or peeling Weight gain, weight loss, belly pain Changes in taste Chest pain Abnormal heartbeat which may cause fainting Swelling and redness at the site of the medication injection Hives Blood clot which may cause swelling, pain, shortness of breath Liver damage, which may cause yellowing of eyes and skin Allergic reaction which may cause rash, low blood pressure, wheezing, shortness of breath, swelling of the face or throat Confusion, dizziness Muscle weakness or muscle aches Inability to move shoulder or turn head Blurred vision, watering eyes Discomfort from light Abnormal fluid shifts in the body which may cause shortness of breath Kidney damage which may require dialysis Scarring of the lungs Blockage of the airway which may cause shortness of breath, cough, wheezing Dehydration Abnormal body movement including the eye and eyelid Difficulty walking, using your hands, opening mouth, talking, with balance and hearing, smelling, eating, sleeping, emptying the bladder Hearing loss

In 100 people receiving FOLFOX (Leucovorin, 5Fluorouracil, Oxaliplatin), 3 or fewer may have:  
Damage to the heart, which may cause shortness of breath A new cancer resulting from treatment of this cancer More severe redness, pain or peeling of palms and soles Internal bleeding which may cause black or tarry stool, blood in vomit or urine, or coughing up blood Change in voice Bleeding from multiple sites including vaginal bleeding, bleeding of the testis, or bleeding of the brain

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COMMON, SOME MAY BE

SERIOUS

In 100 people receiving short course radiation, more than 20 and up to 100

may have:


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Fatigue Diarrhea Rectal Pain/Pressure Perineal Skin Irritation Dysuria OCCASIONAL, SOME MAY BE SERIOUS  
In 100 people receiving short course radiation, from 4 to 20 may have:  
Vomiting Abdominal Pain Bowel Obstruction Fecal Incontinence

You should not become pregnant or father a baby while on this study because the drugs in this study can affect an unborn baby. Women should not breastfeed a baby while on this study. It is important you understand that you need to use birth control while on this study.  
Check with your study doctor about what kind of birth control methods to use and how long to use them. The radiation and some of the drugs used in this study may make you unable to have children in the future. For more information about risks and side effects, ask your study doctor. You should expect to use birth control for up to one year after study treatment.

In this study you will undergo periodic CT scans, MRI scans, and evaluation by a surgical oncologist using proctoscopy or sigmoidoscopy.  
You will be exposed to radiation from CT scans. The amount of radiation you receive from these diagnostic tests is considered low. The dye injected in your vein during the CT scan may cause pain, burning sensation, hot flushes, and a severe allergic reaction, particularly in those with prior allergies to iodine. CT contrast solution can cause kidney damage, especially if you are diabetic, dehydrated or elderly.  
MRI studies do not expose you to radiation. However, they are longer exams than CT scans and may cause anxiety during examination. We can pre-medicate some individuals for this affect.  
Contrast solution may also be used by IV, with a low risk of allergic reaction, dizziness, headache. However, the contrast solution may need to be held if you have any past kidney injury.  
Blood samples will be taken during your clinic visits. The risk of blood drawing includes discomfort at the site of the blood draw with bruising, bleeding, infection and rarely, fainting and nerve damage.  
You should always check with your study doctor before you start using any additional treatments during the study.  
The study team may be notified if you receive other health care services at URMC or its Affiliates (e.g., visit to the emergency room). In addition, the following individuals may know Page 7 of 13  
RSRB\#: STUDY00003244 you participated in research and may see results of testing conducted for this study:  
Staff at the University of Rochester Medical Center and its Affiliates (e.g., Strong Memorial Hospital, Highland Hospital, URM primary care, specialist physician offices)  
who have a reason to access your electronic health record.  
Health care providers who are involved in your care at a facility that is not part of the University of Rochester Medical Center and its Affiliates and who have reason to access your electronic health record.  
Individuals who request a copy of information from your health record for activities such as treatment or payment (e.g., medical insurance companies, worker's compensation).

If you are directly injured by the drug(s) being studied, or by medical procedures needed because of this study, and you receive medical care for the injury, you may need to pay for that care. You will be reimbursed for reasonable and necessary medical costs for such care, but you might not be reimbursed for care covered and paid for by a third party like your health insurance provider, or costs such as required co payments or deductibles related to that coverage. No other funds have been set aside to pay for such things as lost wages or expenses due to a current underlying illness or condition.  
If your research injury is paid for by the University, we will collect your name, date of birth, gender, and Medicare Health Insurance Claim Number or Social Security Number to determine your Medicare status. This information will be used only in accordance with the law.  
If you are a Medicare beneficiary, information about the study you are in, and any payments made related to your injury, will be reported to the Centers for Medicare &  
Medicaid Services (CMS), in accordance with CMS requirements. This information will not be used for any other purpose.
Clinical trial: NCT03781323
Section: Procedures
Subsections: Description Of Study Procedures:

If you choose to participate in this study, you will be asked to have initial testing prior to beginning the study. This will include blood work, up to nine MRI/CT scans, rectal examination with sigmoidoscopy or proctoscopy (the insertion of a rigid scope into the rectum to evaluate for a cancer) by a surgical oncologist if you are female, you will have a pregnancy test. The specific imaging tests that will be required include both CT scans and MRI scans. You may have had some of these studies completed prior to enrolling in this study; if so, you may not need to have them repeated. All imaging scans that are completed will be performed as part of the standard of care.  
In addition, you may be asked to provide an additional blood sample to be used to identify potential markers of rectal cancer. This blood work would be collected at the same time as other standard blood draws and is optional.  
Once testing requirements are complete and you have been found eligible to participate, you will begin treatment. You will have six cycles of FOLFOX therapy (5-fluorouracil, leucovorin, and oxaliplatin) given as IV therapy every two weeks, as well as close monitoring by your medical oncologist. After the first six cycles, you will be evaluated for response with another examination by your surgical oncologist and imaging to make sure the chemotherapy is working against the cancer.  
If the cancer is shrinking, you will proceed with four to six additional cycles of FOLFOX  
chemotherapy. If the cancer appears to have not changed or is growing, it is unlikely more chemotherapy will be beneficial. If this is the case, then you will receive standard of care chemotherapy and radiation followed by surgery.  
At the end of 10-12 cycles of chemotherapy, you will again be evaluated by a surgical oncologist and MRI imaging. If you have had a favorable response and the tumor has resolved, you will not need to have surgery, but you will be periodically evaluated for any recurrence of cancer. If the cancer does progress or return, you may need surgery.  
If by the end of 10-12 cycles, your tumor has responded but is not completely gone, you will require radiation and surgery.  
During the study, you will have the following assessments:  
You will be asked about your medical history and current medications you are taking.  
You will have physical exams (including vital signs, blood pressure, weight, temperature)  
You will have routine blood work to look at your blood counts, liver and kidney function and your electrolytes. Approximately 1 teaspoon will be taken each time this is drawn.  
You will have routine MRI scans of your pelvis and rectal examinations with Page 3 of 13 sigmoidoscopy or proctoscopy by a surgical oncologist. You will also have CT scans every 6-12 months per standard of care to make sure the cancer has not spread to any other  
parts of the body by metastasis.  
All subjects will also complete a quality of life questionnaire at the beginning of the study and then every 3-6 months throughout the duration of the study.  
Information about your study participation and study results may be included in your electronic health record. If you have concerns about this or to obtain more detail, you should discuss this with the study team.
Clinical trial: NCT03781323
Section: Voluntary Participation
Subsections: Voluntary Participation|Subject Consent

Participation in this study is voluntary. You are free not to participate or to withdraw at any time, for whatever reason, without risking loss of present or future care you would otherwise expect to receive. In the event that you do withdraw from this study, the information you have already provided will be kept in a confidential manner.

I have read (or have had read to me) the contents of this consent form and have been encouraged to ask questions. I have received answers to my questions. I agree to participate in this study. I will receive (or will receive) a signed copy of this form for my records and future reference.  
Subject Name (Printed by Subject)  
Signature of Subject Date
Clinical trial: NCT03781323
Section: Withdrawal from Study
Subsections: Circumstances For Removal From Study

There are some cases where you could be removed from the study without your consent.  
You may be withdrawn from the study if your disease does not improve or becomes worse or if your study doctor feels that staying in the study is harmful to your health. You may be withdrawn from the study if you do not keep appointments for study visits, if you experience a treatment delay, or if you cannot complete study activities.  
You also may decide that you no longer wish to participate in this research study. If you decide you would like to stop being in this study, we ask that that you notify your study doctor or study coordinator of your decision to stop participation.