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Because of the difficulties of participant enrollment.
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Short description for lay public, include brief statement of the study hypothesis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy first without primary tumor resection | Experimental | Patients will receive chemotherapy first without primary tumor resection. |
|
| Primary tumor resection followed by chemotherapy | Active Comparator | Patients will receive primary tumor resection followed by chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Systemic chemotherapy | Procedure |
| ||
| primary tumor resection (PTR) |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years after allocation |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Sacred Heart Hospital | Anyang-si | Gyeonggi-do | South Korea | |||
| National Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26782254 | Derived | Kim CW, Baek JH, Choi GS, Yu CS, Kang SB, Park WC, Lee BH, Kim HR, Oh JH, Kim JH, Jeong SY, Ahn JB, Baik SH. The role of primary tumor resection in colorectal cancer patients with asymptomatic, synchronous unresectable metastasis: Study protocol for a randomized controlled trial. Trials. 2016 Jan 19;17:34. doi: 10.1186/s13063-016-1164-0. |
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| Procedure |
primary tumor resection (PTR) using open or laparoscopy or robotic surgery |
|
| Ilsan |
| Gyeonggi-do |
| South Korea |
| Gachon University, Gil Hospital | Incheon | Gyeonggi-do | South Korea |
| Seoul National University, Bundang Hospital | Seongnam-si | Gyeonggi-do | South Korea |
| Yeongnam University Hospital | Daegu | Gyeongsang-do | South Korea |
| Wonkwang University Hospital | Iksan | Jeollabukdo | South Korea |
| Chonnam National University Hospital | Gwangju | Jeonlla Nam-do | South Korea |
| Kyungpook National University Hospital | Daegu | South Korea |
| Department of Surgery, Yonsei University College of Medicine | Seoul | 120-752 | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Yonsei University, Gangnam Severance Hospital | Seoul | South Korea |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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