Resection vs no Resection of the Primary in Colorectal Cancer With Unresectable Metastases
Status:
Terminated
Trial end date:
2020-02-01
Target enrollment:
Participant gender:
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%).