Cytoreduction and Intraperitoneal Chemotherapy Versus Systemic Chemotherapy in Colorectal Peritoneal Carcinomatosis

Study Overview
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Brief Summary
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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.

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

Conditions
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Colorectal Peritoneal Carcinomatosis

Intervention / Treatment
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* Drug: Systemic chemotherapy alone (oxaliplatin, 5-fluorouracil, isovorin)
* Procedure: Cytoreductive surgery (CRS) plus postoperative intraperitoneal chemotherapy (5-fluorouracil, isovorin)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A: CRS plus postop intraperitoneal chemotherapy.<br>Cytoreductive surgery and postoperative intraperitoneal chemotherapy. | Procedure: Cytoreductive surgery (CRS) plus postoperative intraperitoneal chemotherapy (5-fluorouracil, isovorin)<br>* 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.<br>|
| Active Comparator: Arm B: Systemic chemotherapy alone<br>Systemic chemotherapy alone | Drug: Systemic chemotherapy alone (oxaliplatin, 5-fluorouracil, isovorin)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer, cytoreductive surgery, intraperitoneal chemotherapy, systemic chemotherapy, Peritoneal Metastatic Disease From the Colon or Rectum