Role of surgery and heated intra-abdominal chemotherapy in patients with large bowel cancer that has spread to the abdominal lining membrane

Phase 2

• Conditions: Health Condition 1: null- Colorectal Adenocarcinoma

• Registration Number: CTRI/2017/08/009498
• Lead Sponsor: Investigator initiated trial

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 15

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) <= 20 by helical CT scan and/or staging laparoscopy

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 < 5 cm mass in the epigastric region on cross-sectional imaging

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 <65 years

3.Absolute neutrophil count > 1,200/mm³

4.WBC > 4,000/mm³

5.Platelet count 150,000/mm³

6.INR <= 1.5

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 <= 1.5 mg/dL

9.Alkaline phosphatase < 2.5 times upper limit of normal (ULN)

10.SGOT < 1.5 times ULN

11.Serum creatinine normal

12.BUN normal

Exclusion Criteria

•Not pregnant or nursing

•Fertile patients must use effective contraception

•No history of severe congestive heart failure or severe pulmonary disease

oPatients 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study the 2 years Progression-free survival of patients treated with these regimens.Timepoint: 2 years

Secondary Outcome Measures

Name	Time	Method
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. <br/ ><br>B: To study the toxicity of these regimens in these patients.Timepoint: 2 years