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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02149784
Other study ID # 20140413
Secondary ID
Status Recruiting
Phase Phase 3
First received May 18, 2014
Last updated April 25, 2017
Start date September 2015
Est. completion date July 2019

Study information

Verified date April 2017
Source Sun Yat-sen University
Contact Gong Chen, Prof.
Phone +86 20 87343584
Email Chengong@sysucc.org.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 480
Est. completion date July 2019
Est. primary completion date July 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Surgical resection of primary tumor
Surgical resection of primary tumor of mCRC patients who were respond to first line chemotherapy`

Locations

Country Name City State
China Sun Yat-Sen University Cancer Center Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival 3 years
Secondary Number of Participants with Adverse Events both in surgery group and chemotherapy group 2 years
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