NCT02149784UnknownPhase 3
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
Sun Yat-sen University1 site in 1 country480 target enrollmentStarted: September 1, 2015Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 480
- Locations
- 1
- Primary Endpoint
- Overall survival
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Surgical treatment group
Experimental
Unresectable mCRC patients who respond to chemotherapy will receive surgical resection of primary tumor.
Intervention: Surgical resection of primary tumor (Procedure)
Chemotherapy group
No Intervention
Unresectable mCRC patients who were respond to chemotherapy will continue with chemotherapy.
Outcomes
Primary Outcomes
Overall survival
Time Frame: 3 years
Secondary Outcomes
- Number of Participants with Adverse Events both in surgery group and chemotherapy group(2 years)
Investigators
Gong Chen
Sun Yat-Sen University Cancer Center
Sun Yat-sen University
Study Sites (1)
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