The Value of Palliative Primary Tumor Resection in Metastatic Colon Cancer
NCT ID: NCT04416854
Last Updated: 2020-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
627 participants
INTERVENTIONAL
2020-04-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Chemotherapy plus surgery
Chemotherapy plus surgery: Four cycles of XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy accroding to gene testing. After 4 cycles, the patients are randomized to surgery group. Patients receive palliative resection of Primary tumor. Then the rest four cycles XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy are administrated.
resection of primary tumor
resection of primary lesion with unresectablely metastatic colon cancer
XELOX
Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle
mFOLFOX6
Oxaliplatin 85mg/m2, leucovorin 400mg/m2 ivgtt d1 and 5-FU 400 mg/m2 IV bolus d1，2400 mg/m2 CIV 46h, d1
Chemotherapy alone
Chemotherapy alone: Four cycles of XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy accroding to gene testing. After 4 cycles, the patients are randomized to chemotherapy group. The rest four cycles XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy are administrated.
XELOX
Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle
mFOLFOX6
Oxaliplatin 85mg/m2, leucovorin 400mg/m2 ivgtt d1 and 5-FU 400 mg/m2 IV bolus d1，2400 mg/m2 CIV 46h, d1
Interventions
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resection of primary tumor
resection of primary lesion with unresectablely metastatic colon cancer
XELOX
Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle
mFOLFOX6
Oxaliplatin 85mg/m2, leucovorin 400mg/m2 ivgtt d1 and 5-FU 400 mg/m2 IV bolus d1，2400 mg/m2 CIV 46h, d1
Eligibility Criteria
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Inclusion Criteria
* ECOG (Eastern Cooperative Oncology Group) 0-1 and expected survival period for 6 months or more
* Pathological diagnosis of colon cancer adenocarcinoma
* At least one measurable objective tumor lesions which could be evaluated.
* Primary and metastatic tumors exist at the same time, and distant metastases are not resectable
* ANC≥1.5\*109/L；PLT≥90\*109/L；HB≥90g/L；TBI≤1.5(UNL); ALT、AST≤2.5ULN；Cr≤1.0(ULN) screening within 7 days
* No systemic chemotherapy
* Patients with voluntary participation, and sign the informed consent
Exclusion Criteria
* Multiple primary colorectal carcinoma
* Malignant peritoneal effusion or metastatic carcinoma of the peritoneum
* Uncontrolled pleural effusion
* Malignant tumour of the past five years with other organizations to source, but the full treatment of cervical carcinoma in situ and except skin basal cell carcinoma and squamous cell carcinomas
* With brain metastasis or meningeal metastasis
* Pregnancy or breast-feeding women
* Alcohol or drug addictions
* There is an important organ failure or other serious diseases, including coronary artery disease, symptomatic cardiovascular disease or myocardial infarction within 12 months; serious neurological or psychiatric history; severe infection; actively disseminated vascula blood coagulation
18 Years
75 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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LI XIN-XIANG
Professor
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FDPRMCC
Identifier Type: -
Identifier Source: org_study_id
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