A Randomized, Prospective, Multicenter Study for the Role of Primary Tumor Resection in Colorectal Cancer Patients With Asymptomatic, Synchronous Unresectable Metastasis

Study Overview
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Brief Summary
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Short description for lay public, include brief statement of the study hypothesis

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Procedure: Systemic chemotherapy
* Procedure: primary tumor resection (PTR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age : between 20 and 90 years old Histologically confirmed adenocarcinoma of the colon or the upper rectum Patients with resectable primary colon or upper rectal cancer and unresectable metastatic lesions. Patients with no primary cancer related symptoms. ECOG performance status of 0 - 2 Appropriate organ functions (hepatic transaminases - less than 5 times the normal range; bilirubin - less than 2 times the normal range; creatinine serum - less than 1.5 times the normal range; thrombocyte - more than 100,000/µl; neutrophil - more than 1,500/µl) ASA score of < 3 An informed consent form has been signed by the patient. Exclusion Criteria: The patient received adjuvant chemotherapy within the past 6 months. The patient received chemotherapy for metastatic colon cancer. The patient was planning to have curative surgery for the metastatic lesions. The primary cancer is unresectable. Patients with peritoneal carcinomatosis. Patients with mid and low rectal cancer (< 10cm) Patients with primary tumor related complications such as intestinal obstruction, intractable bleeding, and perforation, that needs to be treated. ASA score of > 4 The patient has chronic hepatitis or cirrhosis. An asymptomatic HBV or HCV carrier can participate. Patients with an active infection, which need antibiotic therapy, during the randomization period. Pregnant or breastfeeding women Patients who were enrolled in another clinical trial during the time of enrollment (within the 28 day randomization period). Patients with another different malignant tumor during the past 5 years. Patients with treated non-melanoma skin cancer or cervical cancer can be enrolled in this study.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 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 first without primary tumor resection<br>Patients will receive chemotherapy first without primary tumor resection. | Procedure: Systemic chemotherapy<br> <br> |
| Active Comparator: Primary tumor resection followed by chemotherapy<br>Patients will receive primary tumor resection followed by chemotherapy. | Procedure: primary tumor resection (PTR)<br>* primary tumor resection (PTR) using open or laparoscopy or robotic surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the overall survival between patients who underwent primary tumor resection and patients who received chemotherapy without primary tumor resection | Comparison of the overall survival between patients who underwent primary tumor resection followed by chemotherapy and patients who received chemotherapy without primary tumor resection in stage IV colorectal cancer patients with unresectable metastasis. | 2 years after allocation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of primary tumor related complications in the chemotherapy group and postoperative complications in the primary tumor resection followed by the chemotherapy group. |  | 2 years after allocation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal cancer, Primary tumor resection, Chemotherapy, Overall survival, Quality of life