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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01978249
Recruitment Status : Terminated (Because of the difficulties of participant enrollment.)
First Posted : November 7, 2013
Last Update Posted : August 14, 2018
Information provided by (Responsible Party):
Yonsei University

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

Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: Systemic chemotherapy Procedure: primary tumor resection (PTR) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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 ]

Other Outcome Measures:
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01978249

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Korea, Republic of
University Sacred Heart Hospital
Anyang, Gyeonggi-do, Korea, Republic of
National Cancer Center
Ilsan, Gyeonggi-do, Korea, Republic of
Gachon University, Gil Hospital
Incheon, Gyeonggi-do, Korea, Republic of
Seoul National University, Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of
Yeongnam University Hospital
Daegu, Gyeongsang-do, Korea, Republic of
Wonkwang University Hospital
Iksan, Jeollabukdo, Korea, Republic of
Chonnam National University Hospital
Gwangju, Jeonlla Nam-do, Korea, Republic of
Kyungpook National University Hospital
Daegu, Korea, Republic of
Department of Surgery, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Asan Medical Center
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Yonsei University, Gangnam Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Yonsei University Identifier: NCT01978249    
Other Study ID Numbers: 4-2013-0277
First Posted: November 7, 2013    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Keywords provided by Yonsei University:
Colorectal cancer
Primary tumor resection
Overall survival
Quality of life
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases