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

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

Study Overview

• Status: Terminated
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: Systemic chemotherapy; Procedure: primary tumor resection (PTR)

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of
    • Kyungpook National University Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of, 120-752
    • Department of Surgery, Yonsei University College of Medicine
  • Seoul, Korea, Republic of
    • Yonsei University, Gangnam Severance Hospital
  • Gyeonggi-do
    • Anyang, Gyeonggi-do, Korea, Republic of
      • University Sacred Heart Hospital
    • Ilsan, Gyeonggi-do, Korea, Republic of
      • National Cancer Center
    • Incheon, Gyeonggi-do, Korea, Republic of
      • Gachon University, Gil Hospital
    • Seongnam-si, Gyeonggi-do, Korea, Republic of
      • Seoul National University, Bundang Hospital
  • Gyeongsang-do
    • Daegu, Gyeongsang-do, Korea, Republic of
      • Yeongnam University Hospital
  • Jeollabukdo
    • Iksan, Jeollabukdo, Korea, Republic of
      • Wonkwang University Hospital
  • Jeonlla Nam-do
    • Gwangju, Jeonlla Nam-do, Korea, Republic of
      • Chonnam National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Yonsei University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: October 31, 2013
• First Submitted That Met QC Criteria: November 6, 2013
• First Posted (Estimate): November 7, 2013

Study Record Updates

• Last Update Posted (Actual): August 14, 2018
• Last Update Submitted That Met QC Criteria: August 12, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Colorectal cancer; Quality of life; Chemotherapy; Overall survival; Primary tumor resection
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 4-2013-0277