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Trial record 1 of 1 for:    NCT01978249
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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

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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
Sponsor:
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) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT01978249


Locations
Korea, Republic of
Department of Surgery, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01978249     History of Changes
Other Study ID Numbers: 4-2013-0277
First Posted: November 7, 2013    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016

Keywords provided by Yonsei University:
Colorectal cancer
Primary tumor resection
Chemotherapy
Overall survival
Quality of life

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases