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Status unknownNCT02149784Updated Apr 27, 2017

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

A Phase 3 interventional study of Surgical resection of primary tumor in Colorectal Cancer Metastatic, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-04-27.

Sponsored by Sun Yat-sen University · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
480
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study 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.

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Conditions studied

  • Colorectal Cancer Metastatic

Keywords

  • Metastasis colorectal cancer
  • Chemotherapy
  • Resection of primary tumor
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In context

Colorectal Neoplasms

5,598 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.

This study's planned enrollment of 480 is above the median of 77 across 4,122 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
480 participants (estimated)

Study arms

  • Experimental
    Surgical treatment group

    Unresectable mCRC patients who respond to chemotherapy will receive surgical resection of primary tumor.

    Procedure: Surgical resection of primary tumor

  • No intervention
    Chemotherapy group

    Unresectable mCRC patients who were respond to chemotherapy will continue with chemotherapy.

Interventions

  • ProcedureSurgical resection of primary tumor

    Surgical resection of primary tumor of mCRC patients who were respond to first line chemotherapy'

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What researchers measure

Primary outcomes

  1. Overall survival

    Time frame: 3 years

Secondary outcomes

  1. Number of Participants with Adverse Events both in surgery group and chemotherapy group

    Time frame: 2 years

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Study locations

1 of 1 sites recruiting
  • Sun Yat-Sen University Cancer Center
    Guangzhou, Guangdong 510060, China
    • Gong Chen, Prof. · Contact · chengong@sysucc.org.cn · +86 20 87343584
    • Gong Chen, Prof. · Principal 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. · Sub investigator
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02149784
Lead sponsor
Sun Yat-sen University
Responsible party
Gong Chen (Sun Yat-Sen University Cancer Center, Sun Yat-sen University) — Principal investigator
First posted
May 29, 2014
Start date
Sep 2015
Primary completion
Jul 2018 (estimated)
Completion
Jul 2019 (estimated)
Last update
Apr 27, 2017

Study contacts

Gong Chen, Prof.
Contact
Chengong@sysucc.org.cn
+86 20 87343584
Gong Chen, Prof.
principal investigator · Sun Yat-sen University
Zhi-zhong Pan, Prof.
study chair · Sun Yat-sen University
De-Sen Wan, Prof.
study director · Sun Yat-sen University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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