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

Not Applicable

Terminated

Interventions: Procedure: primary tumor resection (PTR)
Procedure: Systemic chemotherapy

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

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Primary tumor resection followed by chemotherapy	primary tumor resection (PTR)	Patients will receive primary tumor resection followed by chemotherapy.
Chemotherapy first without primary tumor resection	Systemic chemotherapy	Patients will receive chemotherapy first without primary tumor resection.

Primary Outcome Measures

Name	Time	Method
Comparison of the overall survival between patients who underwent primary tumor resection and patients who received chemotherapy without primary tumor resection	2 years after allocation	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.

Secondary Outcome Measures

Name	Time	Method
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

Locations (12): Chonnam National University Hospital
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Gwangju, Jeonlla Nam-do, Korea, Republic of
University Sacred Heart Hospital
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Anyang, Gyeonggi-do, Korea, Republic of
Gachon University, Gil Hospital
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Incheon, Gyeonggi-do, Korea, Republic of
Asan Medical Center
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Seoul, Korea, Republic of
National Cancer Center
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Ilsan, Gyeonggi-do, Korea, Republic of
Department of Surgery, Yonsei University College of Medicine
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Seoul, Korea, Republic of
Seoul National University, Bundang Hospital
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Seongnam-si, Gyeonggi-do, Korea, Republic of
Wonkwang University Hospital
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Iksan, Jeollabukdo, Korea, Republic of
Kyungpook National University Hospital
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Daegu, Korea, Republic of
Yeongnam University Hospital
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Daegu, Gyeongsang-do, Korea, Republic of
Seoul National University Hospital
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Seoul, Korea, Republic of
Yonsei University, Gangnam Severance Hospital
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Seoul, Korea, Republic of