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Title   HIPEC and Cytoreductive Surgery for patients with Peritoneal Carcinomatosis
Full Title   Phase II Trial of Cytoreduction + Hyperthermic Intraperitoneal Mitomycinc+ Standard Systemic Therapy In Patients With Peritoneal Carcinomatosis
Disease/Condition   Gastrointestinal Cancer
Description   Peritoneal carcinomatosis (PC) refers to extensive spreading of tumors on the peritoneal surfaces of the abdomen. PC is a common mode of spread of cancers of gastrointestinal (organs from the stomach to the intestines) origin, gynecologic (Ovaries, or Uterus) tumors and occasionally cancers from other sites. PC is a major cause of treatment failure, and death in cancer patients. It often causes a marked decline in quality of life and presents as pain, ascites (fluid filling the abdominal cavity), and difficulty in intestinal movement. These conditions are caused by worsening involvement of the peritoneal surfaces by tumor planted within the peritoneal (abdominal wall) cavity.

This study will be conducted recognizing the importance of surgical
regularity and quality control, as well as hyperthermic intraperitoneal mitomycin-C (HIPEC) for patients with malignancy of colorectal, appendiceal, pseudomyxoma, peritoneal mesothelioma or gastric origin having surgically treatable spreading of peritoneal disease, absent obvious disease spread to the lymph nodes of the abdomen, and who are considered suitable candidates for aggressive treatment with surgery and HIPEC.
Eligibility Criteria   1) Age 18 years and older
2) The patient must have newly diagnosed, previously untreated confirmed cancer of colorectal, appendiceal, peritoneal mesothelioma, pseudomyxoma or gastric origin with known disease spread limited to the peritoneal surfaces.
3) The patient must have documented disease limited to the peritoneal surface, amenable to complete cytoreduction (Surgery) indicated by:
a) Disease is only found in the peritoneal surfaces
b) No disease spread to the liver
c) No spread to the lymph nodes noted on scans or via symptom presentation before surgery
4) Patient is able to perform daily activities without major obstacle due to disease state
5) Adequate functioning of kidneys, liver and stable blood chemistry as shown by lab results
6) Satisfactory heart and lung function (no history of severe congestive heart failure or severe pulmonary disease, as indicated by clinically acceptable risks to undergo major abdominal - cytoreductive surgery)
Exclusion Criteria   1) The patients have documented disease beyond the peritoneal surfaces, which prevent achieving complete surgical removal of disease as indicated by:
a) Evidence of cancer spread to other organs or lymph nodes
b) Evidence of blockage of the bile duct
c) Evidence of disease of the small intestine characterized by abnormal tissue appearance or functioning which would prevent a complete removal of cancer spread to peritoneal surfaces
2) Significant history of a medical problem that would prevent the patient from undergoing a major abdominal operation such as a history of severe congestive heart failure or active heart disease
3) Active infections, blood clotting disorders, or other major medical illnesses preventing major surgery
4) Significant lung dysfunction as shown by abnormal chest CT scan or poor breathing tests
5) Patients in pregnant or breast feeding
Principal Investigator   Timothy J. Kennedy, MD
Contact Name   Estella Forbes
Phone   (718) 862-8840
Contact Email   Estella Forbes
Post Date   11/18/2011
Protocol Number   11-09-332
Inclusion/Notes   Interventional
Status   Active