Cytoreduction and Intraperitoneal Chemotherapy Versus Systemic Chemotherapy in Colorectal Peritoneal Carcinomatosis

Phase 3

Completed

• Conditions: Colorectal Peritoneal Carcinomatosis
• Interventions: Procedure: Cytoreductive surgery (CRS) plus postoperative intraperitoneal chemotherapy (5-fluorouracil, isovorin); Drug: Systemic chemotherapy alone (oxaliplatin, 5-fluorouracil, isovorin)

• Registration Number: NCT01524094
• Lead Sponsor: Uppsala University

Brief Summary

The purpose of this study is to see if there is a difference in survival between two different treatment strategies for colorectal peritoneal surface disease. The control arm administered the currently considered standard treatment which is palliative systemic chemotherapy. The experimental arm received the combination treatment cytoreductive surgery and intraperitoneal chemotherapy. The investigators hypothesis is that the combination treatment will improve the overall survival.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2010-12
• Status Verified: 2012-01
• Study Completion: 2012-01
• Study First Submitted: 2012-01-18
• Study First Submitted QC: 2012-01-31
• Last Update Submitted: 2012-01-31
• Study First Posted: 2012-02-01
• Last Update Posted: 2012-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• Metastatic disease to the peritoneum from colon or rectum (at least two isolated sites of disease)
• verified primary tumor of adenocarcinoma of the colon or rectum
• Potential resectability as judged by the treating surgeon
• Patient is available for follow-up according to the study protocol
• Signed informed consent

Exclusion Criteria

• Extraabdominal metastases or liver metastases
• Paraaortic or other inoperable lymph node metastases
• Clear indication for surgery only (such as obstruction, bleeding or peritonitis)
• Prior treatment of either arm in the study
• Clinical or histopathological diagnosis of Peritoneal Pseudomyxoma
• Age > 80
• Contraindications for chemotherapy
• Pregnancy or breastfeeding
• Ongoing infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: CRS plus postop intraperitoneal chemotherapy.	Cytoreductive surgery (CRS) plus postoperative intraperitoneal chemotherapy (5-fluorouracil, isovorin)	Cytoreductive surgery and postoperative intraperitoneal chemotherapy.
Arm B: Systemic chemotherapy alone	Systemic chemotherapy alone (oxaliplatin, 5-fluorouracil, isovorin)	Systemic chemotherapy alone

Primary Outcome Measures

Name	Time	Method
Overall survival	8 years

Secondary Outcome Measures

Name	Time	Method
progression free survival	8 years
Time to secondary treatment	8 years
Radical resectability	5 years
Quality of life	7 years
Health costs	8 years
Side effects of treatment	6 years

Trial Locations

Locations (1)

Akademiska Sjukhuset (Uppsala University Hospital); 🇸🇪 Uppsala, Sweden