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|Title||ACOSOG Z6091 Cytoreductive Surgery + HIPEC for patients with Colon Cancer Metastasis to the Peritoneum|
|Full Title||Pilot / Phase III Randomized Trial Comparing Standard Systemic Therapy To Cytoreduction + Hyperthermic Intraperitoneal Mitomycinc + Standard Systemic Therapy In Patients With Limited Peritoneal Dissemination Of Colon Adenocarcinoma (NCI/CTEP Protocol USM|
|Description||For patients with newly diagnosed, previously untreated, biopsy proven colon (not appendiceal or rectal origin) adenocarcinoma with documented limited peritoneal disease dissemination. Patients must have documented disease restricted to the peritoneal surface, suitable for complete cytoreductive surgery as indicated by no liver metastases, no obstruction of the small intestine or biliary duct. Patient should not have metastases to the lymph nodes of the retroperitoneal, pelvic, mediastinum, peri-aortic or peri-portal regions. Patients should not have a significant cardiac impairment or medical problem that would preclude them from undergoing a major abdominal surgery. Patients will be randomly assigned to receive either standard chemotherapy only or standard chemotherapy following cytoreductive surgery with intra-peritoneal Mitomycin. |
Full Trial Details available at: http://intranet/websitefiles/mmcintranet25168/body.cfm?id=769&protocolid=1222&filetype=consent
|Eligibility Criteria||1. Age = 18 years |
2. The patient must have newly found, not yet treated with anything, confirmed colon adenocarcinoma with cancer spread to the abdominal cavity found at or around the same time.
3. The patient must have disease that is found to be confined to the abdominal space and is found to removable using surgery.
4. Stable liver and kidney function as proven by blood work to be taken before treatment is considered for the patient.
5. Patients can have received chemotherapy for their colon cancer and its spread to the abdominal space but must not have had more than one type of cancer treatment. If the initial type of chemotherapy was not helpful they cannot have received another prior to surgery.
6. Have stable daily functioning with little to no assistance with daily routine (example: Does not need assistance walking or using the rest room)
|Exclusion Criteria||1. No metastases found in the liver. |
2. No evidence of yellowing of the skin or eyes or too much bilirubin in the body as proven by blood tests.
3. No major cardiac, kidney, or liver disease which would prevent you from having surgery.
4. Patients are not allowed to be receiving other treatment(s) at the time of the study for their colon cancer or its spread to the liver.
5. No other form of cancer which would also need chemotherapy for treatment or surgery.
6. No major illness (mental or physical) which would prevent the patient from having surgery.
7. Women cannot be pregnant or nursing. Must be willing to use contraception during the entire time on study.
8. No cancer spread from the colon found to be in the lymph nodes of the abdomen or near the lungs/heart.
|Principal Investigator||Steven K. Libutti, MD|
|Contact Name||Estella Forbes|
|Contact Email||Estella Forbes|
|Inclusion/Notes||Surgical Intervention with Systemic Therapy|
|Montefiore Clinical Trial||No|
|CHAM Clinical Trial||No|