A Randomized, Prospective, Multicenter Study for the Role of Primary Tumor Resection in Colorectal Cancer Patients With Asymptomatic, Synchronous Unresectable Metastasis
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|ClinicalTrials.gov Identifier: NCT01978249|
Recruitment Status : Terminated (Because of the difficulties of participant enrollment.)
First Posted : November 7, 2013
Last Update Posted : September 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Procedure: Systemic chemotherapy Procedure: primary tumor resection (PTR)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||September 2013|
|Primary Completion Date :||November 2015|
|Study Completion Date :||November 2015|
Experimental: Chemotherapy first without primary tumor resection
Patients will receive chemotherapy first without primary tumor resection.
|Procedure: Systemic chemotherapy|
Active Comparator: Primary tumor resection followed by chemotherapy
Patients will receive primary tumor resection followed by chemotherapy.
Procedure: primary tumor resection (PTR)
primary tumor resection (PTR) using open or laparoscopy or robotic surgery
- Comparison of the overall survival between patients who underwent primary tumor resection and patients who received chemotherapy without primary tumor resection [ Time Frame: 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.
- Analysis of primary tumor related complications in the chemotherapy group and postoperative complications in the primary tumor resection followed by the chemotherapy group. [ Time Frame: 2 years after allocation ]
- To compare the quality of life between the two groups using the Korean version of EORTC QLQ (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire)-C30. [ Time Frame: 2 years after allocation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01978249
|Korea, Republic of|
|Department of Surgery, Yonsei University College of Medicine|
|Seoul, Korea, Republic of, 120-752|