Cytoreduction and Intraperitoneal Chemotherapy Versus Systemic Chemotherapy in Colorectal Peritoneal Carcinomatosis

Sponsor

Uppsala University (Other)

Overall Status

Completed

CT.gov ID

NCT01524094

Collaborator

(none)

Enrollment

Location

Arms

103

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Peritoneal Carcinomatosis	Drug: Systemic chemotherapy alone (oxaliplatin, 5-fluorouracil, isovorin) Procedure: Cytoreductive surgery (CRS) plus postoperative intraperitoneal chemotherapy (5-fluorouracil, isovorin)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

49 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomised Phase-III Study Comparing Cytoreductive Surgery Plus Intraperitoneal Chemotherapy Versus Modern Systemic Chemotherapy in Colorectal Peritoneal Carcinomatosis.

Study Start Date :

Jun 1, 2003

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A: CRS plus postop intraperitoneal chemotherapy. Cytoreductive surgery and postoperative intraperitoneal chemotherapy.	Procedure: Cytoreductive surgery (CRS) plus postoperative intraperitoneal chemotherapy (5-fluorouracil, isovorin) Cytoreductive surgery has the goal of completely resecting all visible tumor tissue in the abdomen. Sequential postoperative intraperitoneal chemotherapy has the purpose of an adjuvant treatment to eradicate microscopic residual tumor and prevent recurrences in the abdomen. The chemotherapy regimen consisted of intraperitoneal 5-fluorouracil 550 mg/ m2 and intravenous isovorin 30 mg/ m2 day 1-6 med cycles every 4-6 weeks. Six cycles were planned.
Active Comparator: Arm B: Systemic chemotherapy alone Systemic chemotherapy alone	Drug: Systemic chemotherapy alone (oxaliplatin, 5-fluorouracil, isovorin) Oxaliplatin 100 mg/ m2 as a 2 h iv infusion + 5-fluorouracil 400 mg/ m2 iv bolus + Isovorin 100 mg/ m2 as a 2 h infusion followed by 5-fluorouracil 2400 mg/ m2 as a 46 h infusion. Each cycle is given every other week until 12 cycles have been administered.

Arm

Intervention/Treatment

Experimental: Arm A: CRS plus postop intraperitoneal chemotherapy.

Cytoreductive surgery and postoperative intraperitoneal chemotherapy.

Procedure: Cytoreductive surgery (CRS) plus postoperative intraperitoneal chemotherapy (5-fluorouracil, isovorin)

Cytoreductive surgery has the goal of completely resecting all visible tumor tissue in the abdomen. Sequential postoperative intraperitoneal chemotherapy has the purpose of an adjuvant treatment to eradicate microscopic residual tumor and prevent recurrences in the abdomen. The chemotherapy regimen consisted of intraperitoneal 5-fluorouracil 550 mg/ m2 and intravenous isovorin 30 mg/ m2 day 1-6 med cycles every 4-6 weeks. Six cycles were planned.

Active Comparator: Arm B: Systemic chemotherapy alone

Systemic chemotherapy alone

Drug: Systemic chemotherapy alone (oxaliplatin, 5-fluorouracil, isovorin)

Oxaliplatin 100 mg/ m2 as a 2 h iv infusion + 5-fluorouracil 400 mg/ m2 iv bolus + Isovorin 100 mg/ m2 as a 2 h infusion followed by 5-fluorouracil 2400 mg/ m2 as a 46 h infusion. Each cycle is given every other week until 12 cycles have been administered.

Outcome Measures

Primary Outcome Measures

Overall survival [8 years]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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