Clinical trial: NCT01683422
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks And Side Effects Related To The Proton Therapy Include Those Which Are:

| Likely                                                                                                                                                                                                                                                                                                                                                                       | Less Likely                                                                                                     | Rare But Serious   |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|--------------------|
| - Stomach pain and intestinal discomfort, which  usually occur during the last three weeks of proton  therapy and generally go away within 2 months after  the treatment is finished - Nausea  - Fatigue - Tanning, redness of skin, and hair loss within the  radiation area, which is temporary - Loss of appetite and weight loss - Mild muscle aches in the area treated | - Vomiting - Infection - Diarrhea - Low blood  counts - Permanently  dry skin in the  radiation  treatment area | - Damage to the liver or kidney - Bowel obstruction, which  could result in abdominal pain,  nausea and vomiting and may require surgery - Gastric, duodenal or smallbowel ulcer formation that can  result in abdominal pain, nausea  and vomiting, and bleeding, and  may require surgery                    |  
Initials________
Date ________
Risks and side effects related to oxaliplatin and capecitabine **include those which are:**  
| Likely                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             | Less Likely                                                                                                                                                                                                                                                                                                                                                                                                             | Rare But Serious                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| - Nausea and vomiting lasting 24-48 hours  following completion of the chemotherapy - Diarrhea - Mouth sores  - Temporary hair loss  - Numbness or tingling in the hands and/or  feet - Numbness of the mouth or throat that can  be made worse by cold weather or cold  drinks - Abdominal pain or cramps - Irritation  of intestines - Infection - Dehydration  - Loss of appetite - Weakness  - Redness and/or drying of the skin,  especially the hands and feet. - Skin or nail darkening  - Skin rash or peeling of skin on hands and  feet - Low blood counts which could lead to an  increased risk of infection, weakness,  and/or bleeding/easy bruising | - Flu-like symptoms such as  fevers, chills, and muscle  aches - Watery eyes, nasal  stuffiness - Irritation of vein used to  administer the drugs - Damage to the liver or  kidney - Constipation - Shortness of breath - Headache - Intestinal Blockage - A loss of phosphorous,  calcium and/or potassium  from the blood - Inflammation of the lungs - Blistering of the palms of  the hands and soles of the  feet | - Confusion or memory loss - Slurred speech - May affect function of the brain - Build-up of scar tissue in lungs - Stroke - Death. There have been re-ported deaths reported in older patients who  had developed weakness, diarrhea,  and low blood pressure. These deaths  may have been the result of  dehydration that was caused by the diarrhea, and an infection. It is  important that the occurrence of diarrhea be promptly reported to your  physician. - A breakdown of red blood cells and  kidney failure known as the hemolytic  uremic syndrome - Heart attack or chest pain - Lung failure - Allergic reaction |
| Reproductive Risks : You should not become pregnant or father a baby while on this study because                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   |                                                                                                                                                                                                                                                                                                                                                                                                                         |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  |  
Reproductive Risks : 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. Some methods might not be approved for use in this study. Some of the drugs used in the study may make you unable to have children in the future. For more information about risks and side effects, ask your study doctor.  
POSSIBLE BENEFITS OF THE RESEARCH: It is not possible to predict whether any personal benefit will result from the use of the study treatment program. The information, which is obtained from this study may be scientifically useful, and in the future may benefit others with pancreatic cancer. The possible benefits of this study treatment may include improved tumor control, with less damage to surrounding healthy tissues, compared with standard radiotherapy or surgery, but this is not guaranteed.  
Initials________
Date ________
VOLUNTARY NATURE OF PARTICIPATION: Your decision to participate in this research is voluntary. You are free to choose either to enter the research study or not to enter the study. There will not be any penalty or loss of benefits for you if you decide not to participate. Before you make your decision, one of the research staff will give you a chance to ask any questions you have about the research study. You will not sign this form unless you have had the chance to ask questions and have received satisfactory answers to your questions. Even after agreeing to take part in this research, you may withdraw from the research at any time. If you do decide to withdraw from the research, there will be no penalty or loss of benefits for you. After withdrawal, you will be offered available care that suits your needs and medical condition. Before withdrawing from this research, you should notify one of the persons involved with the research that you wish to withdraw. This notice will allow that person or someone else supervising the research to inform you if there are medical risks of withdrawal.