Effectiveness Study of Resection of Primary Tumor in Stage IV Colorectal Cancer Patients

April 25, 2017 updated by: Gong Chen, Sun Yat-sen University

Palliative Resection of Asymptomatic Primary Tumor Following Effective Induction Chemotherapy in Colorectal Cancer Patients With Unresectable Distant Metastasis: a Multi-center, Prospective, Randomized Controlled Study

There is still no perfect treatment suggestion for patients with asymptomatic colorectal cancer with unresectable metastatic disease. Whether patients can benefit from palliative resection of primary tumor or not is still waiting for answer. The investigators hypothesis that asymptomatic metastatic colorectal cancer patients who respond to chemotherapy will benefit from primary tumor resection.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

480

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
        • Principal Investigator:
          • Gong Chen, Prof.
        • Sub-Investigator:
          • Rong-Xin Zhang, M.D.
        • Sub-Investigator:
          • Yu-Hong Li, M.D.
        • Sub-Investigator:
          • Ling-Hneg Kong, M.D.
        • Sub-Investigator:
          • Zhi-qiang Wang, PhD.
        • Sub-Investigator:
          • Xiao-Jun Wu, M.D.
        • Sub-Investigator:
          • Zhi-Zhong Pan, M.D.
        • Sub-Investigator:
          • Yan-Hong Deng, M.D.
        • Sub-Investigator:
          • Hui Wang, M.D.
        • Sub-Investigator:
          • Meng Qiu, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 to 70 years old
  • both genders
  • ECOG:0-2 score
  • Pathological confirmed colon cancer or rectal cancer with at least 12 cm far away from anal verge
  • CT,MRI,or PET-CT confirmed metastasis
  • MDT confirmed unresectable metastasis lesion
  • No evidence of obstruction, bleeding, perforation
  • WBC≥4.0×109/L，Neu ≥2.0×109/L，PLT≥100×109/L
  • No contraindication for chemotherapy
  • No evidence of other malignant tumor
  • Expected survival time > 6 months

Exclusion Criteria:

  • mCRC patients who did not respond to first line chemotherapy
  • Require surgical intervention during the primary tumor-related symptoms
  • Obvious coagulopathy
  • Severe heart, liver, kidney damage or other serious uncontrolled medical illness or acute infection, cachexia
  • Severe organ damage after chemotherapy, surgery or unable to continue to systemic chemotherapy
  • Pregnant or lactating women or women of childbearing age who refuse to accept contraception.
  • Nearly three months participated in clinical trials of other persons.
  • Mental abnormalities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Surgical treatment group
Unresectable mCRC patients who respond to chemotherapy will receive surgical resection of primary tumor.
Procedure: Surgical resection of primary tumor
Surgical resection of primary tumor of mCRC patients who were respond to first line chemotherapy'
NO_INTERVENTION: Chemotherapy group
Unresectable mCRC patients who were respond to chemotherapy will continue with chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Adverse Events both in surgery group and chemotherapy group
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Gong Chen, Prof., Sun Yat-sen University
  • Study Chair: Zhi-zhong Pan, Prof., Sun Yat-sen University
  • Study Director: De-Sen Wan, Prof., Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (ANTICIPATED)

July 1, 2018

Study Completion (ANTICIPATED)

July 1, 2019

Study Registration Dates

First Submitted

May 18, 2014

First Submitted That Met QC Criteria

May 25, 2014

First Posted (ESTIMATE)

May 29, 2014

Study Record Updates

Last Update Posted (ACTUAL)

April 27, 2017

Last Update Submitted That Met QC Criteria

April 25, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20140413

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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