Health Condition 1: null- Colorectal Adenocarcinoma
Conditions
Interventions
Intervention1: Oxaliplatin
control -Not applicable: If the patient meets all the operable criteria Cytoreductive surgery is carried out followed by Hyperthermic intraperitoneal chemotherapy with Oxaliplatin 460 mg/m2 .
Control
Sponsors
Investigator initiated trial
Eligibility
Inclusion criteria
Inclusion criteria: Disease characteristics: A. Histologically confirmed adenocarcinoma of the colon or rectum meeting the following criteria: I. Synchronous or metachronous limited peritoneal disease dissemination, as described below II. No appendiceal cancer III. No signet ring cell type B. Disease amenable to complete cytoreduction surgery as indicated by: I. Peritoneal Cancer Index (PCI) II. Up to 3 small, resectable parenchymal hepatic metastases III. No clinical, biochemical or radiological signs of biliary obstruction IV. No symptomatic malignant ascites requiring palliative paracentesis V. Small volume of disease in the gastro-hepatic ligament defined by a VI. No cross-sectional imaging findings indicative of multi-segmental ( > 1 site) small bowel obstruction, small bowel loops matted together, or gross disease of the small bowel mesentery characterized by distortion, thickening, or loss of mesenteric vascular clarity VII. Absence of unresectable deposits over the small intestinal serosa/ mesentery VIII. No clinical or radiological evidence of hematogenous or distant nodal (retroperitoneal, pelvic, mediastinal, peri-portal, or para-aortic) metastasis C. Prior/Concurrent Therapy: Patients who received prior adjuvant therapy for colorectal adenocarcinoma and/or prior first-line systemic therapy for metastatic colorectal adenocarcinoma are eligible for inclusion in the study. Patient characteristics: 1. ECOG performance status 0-1 2. Age 3. Absolute neutrophil count > 1,200/mm³ 4. WBC > 4,000/mm³ 5. Platelet count 150,000/mm³ 6. INR 7. Patients on therapeutic anticoagulant for unrelated medical condition such as atrial fibrillation or anti-thrombocyte treatment allowed provided treatment can be withheld for operation 8. Total serum bilirubin 9. Alkaline phosphatase 10. SGOT 11. Serum creatinine normal 12. BUN normal
Exclusion criteria
Exclusion criteria: • Not pregnant or nursing • Fertile patients must use effective contraception • No history of severe congestive heart failure or severe pulmonary disease o Patients who are status post-revascularization procedures with satisfactory cardiac function are eligible • No acute myocardial infarction within the past 6 months • No significant history of a medical problem or co-morbidity (e.g., severe congestive heart failure or active ischemic heart disease) that would preclude a major abdominal operation • No concurrent second malignancy requiring systemic therapy • No psychiatric or addictive disorders, or other conditions that would preclude the patient from meeting the study requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study the 2 years Progression-free survival of patients treated with these regimens.Timepoint: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| A: To study the 2year overall survival (OS) of patients with limited peritoneal dissemination from colorectal adenocarcinoma treated with CRS and HIPEC along with adjuvant systemic chemotherapy. B: To study the toxicity of these regimens in these patients.Timepoint: 2 years | — |
Countries
India
Contacts
Public ContactDrASRamakrishnan
Cancer Institute (WIA), Chennai.
Outcome results
None listed