NCT02015923

Resection vs no Resection of the Primary in Colorectal Cancer With Unresectable Metastases

Multicenter Randomized Study in Patients With Colorectal Cancer With Unresectable Metastases. Impact of Resection vs no Resection of the Primary Tumour as a Survival Factor

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Hospital Universitari de Bellvitge · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Main outcome: Assess the impact of cancer-related survival at 2 years in patients with unresectable metastatic colorectal cancer treated with chemotherapy alone versus surgery followed by chemotherapy. To assess overall survival. To evaluate postoperative morbidity and mortality in patients treated with resection of the primary tumor. Assess complications and meed for surgery in patients treated with systemic chemotherapy only during the course of the disease. Identify and describe the complications related to chemotherapy and toxicity in the short and medium term systemic treatment. Assessing the quality of life questionnaire QLQ-C30 and QLQ-CR29. To study prognostic survival factors. Method: multicenter randomized clinical trail (22 hospitals). Two parallel group in which to evaluate two therapeutic strategies for colorectal cancer metastasis unresectable stage IV: chemotherapy alone versus primary tumor resection plus chemotherapy. Subjects: patients with unresectable nonmetastatic colorectal cancer. Hypothesis:Surgical resection of the primary tumor in stage IV colorectal patients with unresectable synchronous metastases increases by 14% overall survival compared to patients receiving systemic treatment with chemotherapy without resection of the primary tumor (survival of 34% vs 20%).

Detailed description

Intervention: Arm B (control): chemotherapy alone, regimen according to each center. Arm A (experimental): surgery (complete tumoral resection; R0) followed by chemotherapy, regimen according to each center. Statistical Analysis: A power analysis showed that to assure a significance level of 0,05 and a beta error 0.20. 168 patients are necessary in each arm. It has been estimated a loss rate of up to 10%. Differences between groups will be analyzed by t, U, X2, exact test and survival will be assessed according to Kaplan and Meier method. Evaluation of safety of the trial will be made in the middle of the study statistically

Conditions

• Colonic Cancer
• Unresectable Metastasis Originating in Colonic Cancer

Interventions

Type	Name	Description
PROCEDURE	Colonic resection	Colonic cancer resection, R0 No surgical intervention on metastasis
DRUG	Chemotherapy- scheme	Chemotherapy, specified in each center with or without biological drugs

Timeline

• Start date: 2013-12-01
• Primary completion: 2019-06-01
• Completion: 2020-02-01
• First posted: 2013-12-19
• Last updated: 2021-03-16

Locations

22 sites across 1 country: Spain