Effectiveness Study of Resection of Primary Tumor in Stage IV Colorectal Cancer Patients

Study Overview
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Brief Summary
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There is still no perfect treatment suggestion for patients with asymptomatic colorectal cancer with unresectable metastatic disease. Whether patients can benefit from palliative resection of primary tumor or not is still waiting for answer. The investigators hypothesis that asymptomatic metastatic colorectal cancer patients who respond to chemotherapy will benefit from primary tumor resection.

Official Title
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Palliative Resection of Asymptomatic Primary Tumor Following Effective Induction Chemotherapy in Colorectal Cancer Patients With Unresectable Distant Metastasis: a Multi-center, Prospective, Randomized Controlled Study

Conditions
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Colorectal Cancer Metastatic

Intervention / Treatment
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* Procedure: Surgical resection of primary tumor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 70 years old both genders ECOG:0-2 score Pathological confirmed colon cancer or rectal cancer with at least 12 cm far away from anal verge CT,MRI,or PET-CT confirmed metastasis MDT confirmed unresectable metastasis lesion No evidence of obstruction, bleeding, perforation WBC≥4.0×109/L，Neu ≥2.0×109/L，PLT≥100×109/L No contraindication for chemotherapy No evidence of other malignant tumor Expected survival time > 6 months Exclusion Criteria: mCRC patients who did not respond to first line chemotherapy Require surgical intervention during the primary tumor-related symptoms Obvious coagulopathy Severe heart, liver, kidney damage or other serious uncontrolled medical illness or acute infection, cachexia Severe organ damage after chemotherapy, surgery or unable to continue to systemic chemotherapy Pregnant or lactating women or women of childbearing age who refuse to accept contraception. Nearly three months participated in clinical trials of other persons. Mental abnormalities

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Surgical treatment group<br>Unresectable mCRC patients who respond to chemotherapy will receive surgical resection of primary tumor. | Procedure: Surgical resection of primary tumor<br>* Surgical resection of primary tumor of mCRC patients who were respond to first line chemotherapy'<br>|
| No Intervention: Chemotherapy group<br>Unresectable mCRC patients who were respond to chemotherapy will continue with chemotherapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events both in surgery group and chemotherapy group |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastasis colorectal cancer, Chemotherapy, Resection of primary tumor