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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

Primary Purpose

Colorectal Cancer

Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Systemic chemotherapy
primary tumor resection (PTR)
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal cancer, Primary tumor resection, Chemotherapy, Overall survival, Quality of life

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Sacred Heart Hospital
  • National Cancer Center
  • Gachon University, Gil Hospital
  • Seoul National University, Bundang Hospital
  • Yeongnam University Hospital
  • Wonkwang University Hospital
  • Chonnam National University Hospital
  • Kyungpook National University Hospital
  • Department of Surgery, Yonsei University College of Medicine
  • Asan Medical Center
  • Seoul National University Hospital
  • Yonsei University, Gangnam Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chemotherapy first without primary tumor resection

Primary tumor resection followed by chemotherapy

Arm Description

Patients will receive chemotherapy first without primary tumor resection.

Patients will receive primary tumor resection followed by chemotherapy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Analysis of primary tumor related complications in the chemotherapy group and postoperative complications in the primary tumor resection followed by the chemotherapy group.

Full Information

First Posted
October 31, 2013
Last Updated
August 12, 2018
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01978249
Brief Title
A Randomized, Prospective, Multicenter Study for the Role of Primary Tumor Resection in Colorectal Cancer Patients With Asymptomatic, Synchronous Unresectable Metastasis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
Because of the difficulties of participant enrollment.
Study Start Date
September 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal cancer, Primary tumor resection, Chemotherapy, Overall survival, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chemotherapy first without primary tumor resection
Arm Type
Experimental
Arm Description
Patients will receive chemotherapy first without primary tumor resection.
Arm Title
Primary tumor resection followed by chemotherapy
Arm Type
Active Comparator
Arm Description
Patients will receive primary tumor resection followed by chemotherapy.
Intervention Type
Procedure
Intervention Name(s)
Systemic chemotherapy
Intervention Type
Procedure
Intervention Name(s)
primary tumor resection (PTR)
Intervention Description
primary tumor resection (PTR) using open or laparoscopy or robotic surgery
Primary Outcome Measure Information:
Title
Comparison of the overall survival between patients who underwent primary tumor resection and patients who received chemotherapy without primary tumor resection
Description
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.
Time Frame
2 years after allocation
Secondary Outcome Measure Information:
Title
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 Pre-specified Outcome Measures:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University Sacred Heart Hospital
City
Anyang
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Ilsan
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Gachon University, Gil Hospital
City
Incheon
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Seoul National University, Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Yeongnam University Hospital
City
Daegu
State/Province
Gyeongsang-do
Country
Korea, Republic of
Facility Name
Wonkwang University Hospital
City
Iksan
State/Province
Jeollabukdo
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
State/Province
Jeonlla Nam-do
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Department of Surgery, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Yonsei University, Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
26782254
Citation
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.
Results Reference
derived

Learn more about this trial

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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