The Value of Palliative Primary Tumor Resection in Metastatic Colon Cancer

Study Overview
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Brief Summary
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The aim of this trial is to evaluate the value of palliative primary tumor resection in colon cancer patients with initially unresectable metastases and a positive response to induction chemotherapy which depends on gene testing. The primary endpoint is to evaluate overall survival.

Official Title
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The Value of Palliative Primary Tumor Resection in Colon Cancer Patients With Initially Unresectable Metastases After Induction Chemotherapy: a Prospective, Multicenter, Randomized Controlled Clinical Trial

Conditions
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Metastatic Colon Cancer, Surgery

Intervention / Treatment
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* Procedure: resection of primary tumor
* Drug: XELOX
* Drug: mFOLFOX6


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 75 years old 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: Operation intervention required for perforation, bleeding and obstruction of intestinal cavity 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

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: Chemotherapy plus surgery<br>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. | Procedure: resection of primary tumor<br>* resection of primary lesion with unresectablely metastatic colon cancer<br>Drug: XELOX<br>* Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle<br>Drug: mFOLFOX6<br>* Oxaliplatin 85mg/m2, leucovorin 400mg/m2 ivgtt d1 and 5-FU 400 mg/m2 IV bolus d1，2400 mg/m2 CIV 46h, d1<br>|
| Active Comparator: Chemotherapy alone<br>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. | Drug: XELOX<br>* Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle<br>Drug: mFOLFOX6<br>* Oxaliplatin 85mg/m2, leucovorin 400mg/m2 ivgtt d1 and 5-FU 400 mg/m2 IV bolus d1，2400 mg/m2 CIV 46h, d1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 5-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival 1 | The first progression time after diagnosis | 3-year | 
| Progression-free survival 2 | The first progression time after randomization | 3-year | 
| The rate of adverse events resulted from chemotherapy | The ratio of the number of patients experienced adverse events to the total patients | 3-year | 
| The quality of life postoperatively | The European Organization for Research and Treatment (EORTC)-QLQ-C30 HRQL questionnaire was assessed with repeated measures at regular intervals postoperatively at months 3, 6, 9, 12, 18, and 24 | 3-month, 6-month, 9-month, 12-month, 18-month, 24-month | 
| Objective response rate |  | 1-year | 
| The rate of postoperative complications | The ratio of the number of patients with postoperative complications to the total patients | 1-year | 
| The proportion of surgical intervention in control group |  | 1-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chemotherapy, palliative surgery, stage IV colon cancer