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

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ClinicalTrials.gov Identifier: NCT02149784
Recruitment Status : Unknown
Verified April 2017 by Gong Chen, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : May 29, 2014
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
Gong Chen, Sun Yat-sen University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastatic Procedure: Surgical resection of primary tumor Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Overall survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Number of Participants with Adverse Events both in surgery group and chemotherapy group [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02149784


Contacts
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Contact: Gong Chen, Prof. +86 20 87343584 Chengong@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-Sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Gong Chen, Prof.    +86 20 87343584    chengong@sysucc.org.cn   
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.         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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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

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Responsible Party: Gong Chen, Sun Yat-Sen University Cancer Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02149784     History of Changes
Other Study ID Numbers: 20140413
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Keywords provided by Gong Chen, Sun Yat-sen University:
Metastasis colorectal cancer
Chemotherapy
Resection of primary tumor
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases