Clinical trial: NCT00941655
Section: Alternatives
Subsections: What Other Choices Do I Have If I Do Not Take Part In This Study?

Instead of being in this study, you have these options:
- Getting chemotherapy or surgery for your cancer without being in a study - Taking part in another experimental study
- Getting comfort care, also called palliative care. This type of care helps reduce pain, tiredness, appetite problems and other problems caused by the cancer. It does not treat the cancer directly. Instead, it tries to improve how you feel. Comfort care tries to keep you as active and comfortable as possible.  
STUDY NUMBER: 09-C-0189 CONTINUATION: page 5 of 10 pages Please talk to your doctor about these and other options.
Clinical trial: NCT00941655
Section: Duration of Study Involvement
Subsections: Follow Up

Once you have completed surgery and/or chemotherapy you will return to the NIH Clinical Center for follow up about every 3 months for 2 years, then every 6 months for 3 years and yearly thereafter. If you are not able to return to the NIH Clinical Center, you will be contacted by phone.
Clinical trial: NCT00941655
Section: Participant's Rights
Subsections: Research Subject'S Rights What Are The Costs Of Taking Part In This Study?

If you choose to take part in the study, the following will apply, in keeping with the NIH policy:
- You will receive study treatment at the NIH Clinical Center at no charge to you. This may include surgery, medicines, laboratory testing, x-rays or scans done at the Clinical Center, National Institutes of Health (NIH).  
- If you receive chemotherapy from your local oncologist, that treatment will be billed to your insurance company and you will be responsible for all co-payments and other charges not covered by your insurance company.  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (10-84) NIH-2514-2 (10-84) P.A.: 09-25-0099  
STUDY NUMBER: 09-C-0189 CONTINUATION: page 8 of 10 pages
- Medicines that are not part of the study treatment and are not given at the Clinical Center will not be provided or paid for by the Clinical Center, NIH.  
- Once you have completed taking part in the study, medical care will no longer be provided by the Clinical Center, NIH.
Clinical trial: NCT00941655
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Side Effects Or Risks Can I Expect **From Being In This Study?**|Potential Benefits Of Participation Are There Benefits To Taking Part In This Study?

As described above, the main side effects of the chemotherapy include, diarrhea, which can be severe, ulceration of the mouth, low blood counts, sensitivity to cold in the hands, feet and mouth, allergic reaction, fatigue and loss of fertility. These risks are listed in the tables below. The operation to remove the gastric tumor and any other tumors throughout your abdomen is likely to be quite extensive and may incorporate CHPP as well. The risks from this operation and general anesthesia include: Likely
- Pain
- Temporary slowing or stopping of bowel function, known as an ileus. This could take several days to resolve and may require that the tube in your nose that drains your stomach stay in place longer
- Laboratory studies of the liver, particularly bilirubin may be elevated. This may be due to handling or removing part of the liver during surgery or it may be as a result of one of the chemotherapy drugs. This usually does not cause any symptoms and resolves in a few days.  
- This surgery may also cause changes in your bowel pattern, either constipation or diarrhea. Fluid may develop in your abdomen, known as ascites. This may go away on its own, or may need to be drained if it becomes too uncomfortable.  
Less Likely
- Leakage of bowel contents may occur from an area where the bowel was sewn together or from any area of your bowel due to the effects of the chemotherapy, the increased temperature during CHPP, or from the surgery itself.  
This may cause an infection in your abdomen that may be life threatening and may require an additional operation to repair the leak. Rarely this will cause openings to form from the bowel through the skin or into the abdomen (fistulas) that may require you to stay in the hospital longer, may require antibiotics, or require a second operation to repair.  
- The chemotherapy in your abdomen may also cause irritation to structures surrounding the abdomen, particularly the lining of your lungs. This irritation may result in a condition called "pleural effusion" which means that the lung lining is irritated. This may cause pain and some fluid may collect between the lining and the lung. The fluid usually resolves by itself, but on occasion it may need to be drained with a needle and syringe, if it is causing difficulty breathing.  
- Bleeding which might require transfusions or a second operation to correct
- Blood clots that have the risk of moving to the lungs causing difficulty breathing - Infection in the abdomen, where the incision was made, or in the lungs (pneumonia). All types of infections would be treated with antibiotics.  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (10-84) NIH-2514-2 (10-84) P.A.: 09-25-0099  
STUDY NUMBER: 09-C-0189 CONTINUATION: page 6 of 10 pages Rare but serious:
- Heart failure, lung failure, kidney failure, liver failure, blood clots in your extremities or lungs and stroke This may require treatment in the ICU including need for a breathing machine, dialysis, and blood pressure medications.  
- Damage to the various organs of your body which may cause your death.  
| Risks: Oxalipaltin + 5-FU/LV Likely - these may be mild to severe   | Less Likely - these may be mild to severe                                                                                                                                                               | Rare but Serious   |                     |
|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|---------------------|
| -                                                                   | Tingling of the mouth, lips, hands  and feet - Sensitivity to cold in the  mouth, hands and feet                                                                                                        |                    |                     |
| -                                                                   | Nausea, vomiting, diarrhea, loss  of appetite, weight loss,  constipation, abdominal pain                                                                                                               |                    |                     |
| -                                                                   | Ulceration of the mouth                                                                                                                                                                                 |                    |                     |
| -                                                                   | Decrease in blood counts including  white blood cells (which increase  the risk of infection), red cells  (which may cause fatigue and  weakness) and platelets (which  increase the risk of bleeding). |                    |                     |
| -                                                                   | Tiredness, insomnia, muscle aches, dizziness                                                                                                                                                            |                    |                     |
| -                                                                   | Changes in taste and smell                                                                                                                                                                              |                    |                     |
| -                                                                   | Cough, shortness of breath                                                                                                                                                                              | -                  | Hair loss           |
| -                                                                   | Tumor lysis syndrome (A change in  certain chemicals in the blood, which  may cause damage to organs,  including the kidneys, heart, and liver.)                                                        |                    |                     |
| -                                                                   | Flushing, runny nose, eye irritation,  headache, fever                                                                                                                                                  |                    |                     |
| -                                                                   | Rash - particularly on the hands  and feet                                                                                                                                                              |                    |                     |
| -                                                                   | Changes in lab values that cause no  symptoms and may or may not require  treatment                                                                                                                     |                    |                     |
| -                                                                   | Hiccups                                                                                                                                                                                                 |                    |                     |
| -                                                                   | Mood changes                                                                                                                                                                                            | -                  | Low blood  pressure |
| -                                                                   | Blood clots                                                                                                                                                                                             |                    |                     |
| -                                                                   | Severe allergic  reaction                                                                                                                                                                               |                    |                     |
| -                                                                   | Death                                                                                                                                                                                                   |                    |                     |  
STUDY NUMBER: 09-C-0189 CONTINUATION: page 7 of 10 pages  
| Risks: Irinotecan + 5-FU/LV Likely - these may be mild to severe   | Less Likely - these may be mild to severe                                                                                                                                                               | Rare but Serious   |                                            |
|--------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|--------------------------------------------|
| -                                                                  | Diarrhea, this can be mild to  severe and can occur immediately  following the drug or several days  later                                                                                              |                    |                                            |
| -                                                                  | Runny nose, tearing eyes, abdominal cramping, increased  salivation                                                                                                                                     |                    |                                            |
| -                                                                  | Nausea, vomiting, constipation,  loss of appetite, weight loss                                                                                                                                          |                    |                                            |
| -                                                                  | Decrease in blood counts including  white blood cells (which increase  the risk of infection), red cells  (which may cause fatigue and  weakness) and platelets (which  increase the risk of bleeding). |                    |                                            |
| -                                                                  | Tiredness, insomnia, fever, muscle  aches, pain, dizziness                                                                                                                                              |                    |                                            |
| -                                                                  | Cough, shortness of breath                                                                                                                                                                              |                    |                                            |
| -                                                                  | Changes in taste and smell                                                                                                                                                                              |                    |                                            |
| -                                                                  | Hair loss                                                                                                                                                                                               | -                  | Rash - particularly on the hands and  feet |
| -                                                                  | Changes in lab values that cause no  symptoms and may or may not require  treatment                                                                                                                     | -                  | Low blood  pressure                        |
| -                                                                  | Blood clots                                                                                                                                                                                             |                    |                                            |
| -                                                                  | Death                                                                                                                                                                                                   |                    |                                            |

It is possible that we may be able to remove all of your tumors and that the chemotherapy will keep them from returning but we don't know if this will happen.  
The aim of this study is to see if undergoing surgery before chemotherapy will keep people cancer free longer than chemotherapy alone. We don't know if this is the case. We hope that you will get personal medical benefit from taking part in this study, but we cannot be certain. Because there is not much information about this treatment, we do not know if you will benefit from taking part in this study, although the knowledge gained from this study may help others in the future who have cancer.
Clinical trial: NCT00941655
Section: Procedures
Subsections: What Will Happen If You **Take Part In This Research Study?** Before You Begin The Study|During The Study Surgery|Chemotherapy

Once we have determined that it is safe for you to participate in this study, you will have a laparoscopy. This is a minor surgical procedure that uses a laparoscope, inserted through the abdominal wall, to examine the inside of the abdomen. A laparoscope is a thin, tube-like instrument with a light and a lens for viewing. It may also have a tool to remove tissue to be checked under a microscope for signs of disease. The laparoscopy is to see how much tumor you have in your abdomen. If you have too much disease, you will not be able to participate in the study. After we have the results of the laparoscopy, you will be randomized to either receive surgery followed by chemotherapy or chemotherapy alone.

If you are randomized to the surgery + chemotherapy group:
In order to remove all of the tumors in your abdomen, you will need to have a **major** operation. This will include removing the tumor as well as a large part of your stomach. If you have tumors in your liver, the tumors and some of the surrounding normal tissue will be removed, if you have tumors on other organs they will be removed along with some of the normal surrounding tissue. If you have tumors in your peritoneum (the thin film of tissue that covers all of your abdominal organs) this will be removed and you will undergo a procedure called Continuous Hyperthermic Peritoneal Perfusion (CHPP) while you are in the operating room (see below).  
After the operation you will be admitted to the Intensive Care Unit (ICU) where you will be monitored closely for 1-4 days. As with any major operation, you may have a breathing tube and be connected to a breathing machine for 1-2 days following the operation. You will have a tube in your stomach, a catheter (tube) in your bladder and several IVs during this period. As soon as you are able, you will be helped to get out of bed, to cough and take deep breaths and to walk. Once your bowel function has returned to normal, you will be allowed to eat - this usually takes 4-7 days. When your condition is stable, you will be transferred to the regular patient care unit until you are ready to be discharged to home, usually 7-21 days following the operation. Throughout your hospitalization, you will receive pain medications, IV fluids, antibiotics, and blood transfusions as necessary.

If you are randomized to the chemotherapy group, you will begin treatment within 2 weeks following the laparoscopy. If you are randomized to the surgery group, you will receive chemotherapy about 6-16 weeks following the operation(s).  
The drugs are given in your vein over 2 days every 2 weeks (one cycle) for 12 cycles (about 6 months). You may receive the chemotherapy in the day hospital here at the NIH Clinical Center or at home with your referring oncologist. While you are receiving the drugs, you will need to have your blood drawn about once a week (more if you are having certain side effects), and you will need to see your doctor about every 2 weeks, right before the chemotherapy drugs are given, and you will have scans about every 8 weeks while you are on the chemotherapy. You will also be asked to keep a diary of all of the side effects you may have. You will receive 4 chemotherapy drugs, 5-Fluorouracil (5-FU), leucovorin (LV), oxaliplatin, and irinotecan. These drugs are commonly given together for patients with colon cancer who have metastases in the liver and peritoneum and they have been effective in shrinking the tumors. The main side effects of these drugs when given together include, diarrhea, which can be severe, ulceration of the mouth, low blood counts, sensitivity to cold in the hands, feet and mouth, allergic reaction and fatigue. Your oncologist and chemotherapy nurse will review all of the side effects with you and discuss additional medications you may receive to help prevent or control the side effects. It is also possible that you may lose your fertility following this treatment. If your side effects are severe or your tumors grow while you are taking the chemotherapy, the drugs will be stopped and your physician will discuss additional treatment options with you. Additional side effects are listed in the table in the Risks or Discomforts section.
Clinical trial: NCT00941655
Section: Purpose of Research
Subsections: Why Are You Being Asked To Take Part In This Study?

You have cancer of the stomach which has spread to a few other organs in your body. Based on your CT scans, we think that we could remove all of your tumors. You have met all of the eligibility criteria for this study and so we feel that this procedure would be safe for you.
Clinical trial: NCT00941655
Section: Voluntary Participation
Subsections: Consent To Participate In A Clinical Research **Study** - Adult Patient Or - Parent, For Minor Patient

INSTITUTE: National Cancer Institute STUDY NUMBER: 09-C-0189 PRINCIPAL INVESTIGATOR: Udo Rudloff, M.D., PhD STUDY TITLE: Prospective Randomized Trial Comparing Gastrectomy, Metastasectomy plus Systemic Therapy versus Systemic Therapy Alone: GYMSSA Trial Continuing Review Approved by the IRB on 02/27/12 Amendment Approved by the IRB on 05/21/12 (G) Date Posted To Web: 06/06/12 Standard
Clinical trial: NCT00941655
Section: Withdrawal from Study
Subsections: Stopping Therapy

Your doctor may decide to stop your therapy for the following reasons:
- if he/she believes that it is in your best interest - if your disease comes back during treatment
- if you have side effects from the treatment that your doctor thinks are too severe - if new information shows that another treatment would be better for you In this case, you will be informed of the reason therapy is being stopped.  
You can stop taking part in the study at any time. However, if you decide to stop taking part in the study, we would like you to talk to the study doctor and your regular doctor first.