Clinical trial: NCT02347618
Section: Alternatives
Subsections: Alternatives To Participation

If you decide not to participate in the study, you can choose to receive the standard treatment for pancreatic cancer as determined by your physicians. In addition, you can choose to receive no treatment for your cancer or only palliative treatments that are designed to alleviate symptoms.
Clinical trial: NCT02347618
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. As soon as feasible, any information that can identify you such as your name and date of birth will be erased from the study database. Only your medical record number will be used to identify your participation in the study. All the information gathered from your chart or records will be kept under lock and key. If you have never received a copy of the University of Rochester Medical Center (URMC) and Affiliates Notice of Privacy Practices, please ask the investigator for one What information may be used and given to others? The study doctor will get your personal and medical information. For example:
x Research records x Records about phone calls made as part of this research x Records about your study visits x Past and present medical records related to the study x Results of medical tests Who may use and give out information about you?  
x The study doctor and the study staff x URMC and Affiliates Your information may be given to:
x The Department of Health and Human Services x The University of Rochester Why will this information be used and/or given to others?  
x To do the research x To study the results x 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. 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. 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: NCT02347618
Section: Duration of Study Involvement
Subsections: Duration Of The Study

Your participation in the study will last approximately 5 years. You will undergo diagnostic workup and treatment during the first 1-2 months followed by routine follow up visits for 5 years.
Clinical trial: NCT02347618
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks Of Participation|Compensation For Injury

This study is being conducted because your doctors think that treating pancreatic cancer with preoperative SBRT may improve your outcome compared with standard treatment. There have been several small studies at other institutions which have shown delivering SBRT to the pancreas is safe and effective. However, there is no way to tell in advance whether treatment according to this study will in fact be beneficial. In fact, your doctors may find that treatment according to the study might not be beneficial and could even harm participants. Specifically, delivering SBRT prior to surgical resection could cause side effects that could hamper or delay your surgery, which is the most important treatment for your disease. However, previous studies have demonstrated that the vast majority of patients who undergo preoperative radiation can safely undergo surgery in a timely fashion. Radiation therapy can cause both acute and delayed side effects. Acute side effects that take place during or immediately after treatment can include fatigue, nausea, vomiting, diarrhea, loss of appetite and weight loss. These effects are expected to be mild and can be managed with supportive care like anti-nausea or anti-diarrheal medicines. Delayed side effects can take place months to years after radiation and can include delayed wound healing, scar tissue formation and bowel obstruction and narrowing. These effects are expected to be very rare. There is a risk of invasion of your privacy. All the information gathered from your chart or records, including your name and any other identifying information will be kept strictly confidential and will be kept under lock and key. You will not be identified nor will any information that would make it possible for anyone to identify you be used in any presentation or written reports about this study. Only summarized data will be presented at meetings or in any publications.

If you are directly injured by the SBRT radiation that is being studied, or by the clinical procedures solely required to participate in the study, you may need to pay for treatment of your injuries, but you will not be required to pay for emergency medical treatment provided at Strong Memorial Hospital or Highland Hospital. The University may seek payment for this care from your health insurer or third parties. Decisions regarding care and compensation for any other research related injury will be made on a case-by-case basis.
Clinical trial: NCT02347618
Section: Procedures
Subsections: Description Of Study Procedures

If you decide to take part in this study, you will be scheduled to meet with a radiation oncologist, a specialist in using radiation to treat cancer. Your radiation oncologist will go over this protocol with you and answer any questions you may have. You may need to undergo additional blood work or scans such as CT, MRI or PET to make certain that you meet the criteria for this study. Most of these tests are a routine part of your care. In general, they do not need to be repeated if they have already been completed as part of your diagnostic workup. If your doctor feels it will be helpful to your treatment you may be asked to undergo endoscopic placement of "fiducials" or markers into your pancreatic tumor, which will be used to help guide radiation therapy. Regardless of whether you receive fiducials you will need to undergo a "simulation" procedure for radiation therapy which involves a CT scan in the department of radiation oncology to help map out the radiation. IV contrast may be given during the CT scan to help better visualize the tumor; the radiation oncology doctor will decide if contrast is necessary. Approximately 1-2 weeks after you undergo simulation, you will return to the Department of Radiation Oncology for SBRT radiation treatment. You will receive 5 treatments delivered over a 1-2 week period. Each session lasts approximately 30-45 minutes. Within 3 weeks after you complete your radiation treatment, you are expected to undergo surgery to remove your pancreatic cancer. After your surgery, you will return for a follow up visit with your surgeon and radiation oncologist to evaluate how well you are doing and go over any side effects you may have experienced.
Clinical trial: NCT02347618
Section: Purpose of Research
Subsections: Purpose Of Study

The purpose of this study is to determine if treating your pancreatic cancer with a special kind of radiation therapy called stereotactic body radiation therapy (SBRT) before you have surgery is safe and feasible. Standard treatment for newly diagnosed pancreatic cancer determined to be resectable usually involves undergoing surgery first and then receiving chemotherapy with or without radiation therapy. However, the pancreatic cancer often comes back after this treatment.
Clinical trial: NCT02347618
Section: Voluntary Participation
Subsections: Voluntary Participation|Subject Consent

RSRB Case Number: 00054047 Page 6 of 7 Taking part in this study is voluntary. You are free not to take part or to withdraw at any time, for whatever reason. No matter what decision you make, there will be no penalty or loss of benefit to which you are entitled. 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 have received (or will receive) a signed copy of this form for my records and future reference. Subject Name (Printed by Subject)
Clinical trial: NCT02347618
Section: Withdrawal from Study
Subsections: Circumstances For Dismissal|Early Termination

You may be withdrawn from the study if you do not keep appointments for study visits or if you cannot complete study activities. You may also be withdrawn from the study if your cancer becomes worse or if your doctor feels that staying in the study is harmful to your health.

You may decide to stop participating in the study at any time. You should tell your study doctor as soon as possible so that he or she can explain to you the risks associated with stopping the study. For example, if you choose to stop radiation after beginning treatment, you may be exposed to the side effects of radiation treatment without the expected benefit. Even if you decide to stop participating, your doctors will continue to give you the best treatment possible.