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

Primary Purpose

Colorectal Cancer Metastatic

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Surgical resection of primary tumor

About this trial

This is an interventional treatment trial for Colorectal Cancer Metastatic focused on measuring Metastasis colorectal cancer, Chemotherapy, Resection of primary tumor

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Sun Yat-Sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Surgical treatment group

Chemotherapy group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02149784

First Posted

May 18, 2014

Last Updated

April 25, 2017

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT02149784

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Unknown status

Study Start Date

September 2015 (undefined)

Primary Completion Date

July 2018 (Anticipated)

Study Completion Date

July 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer Metastatic

Keywords

Metastasis colorectal cancer, Chemotherapy, Resection of primary tumor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Surgical treatment group

Arm Type

Experimental

Arm Description

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

Arm Title

Chemotherapy group

Arm Type

No Intervention

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Surgical resection of primary tumor

Intervention Description

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

Primary Outcome Measure Information:

Title

Overall survival

Time Frame

3 years

Secondary Outcome Measure Information:

Title

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

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gong Chen, Prof.

Phone

+86 20 87343584

Chengong@sysucc.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gong Chen, Prof.

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Zhi-zhong Pan, Prof.

Organizational Affiliation

Sun Yat-sen University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

De-Sen Wan, Prof.

Organizational Affiliation

Sun Yat-sen University

Official's Role

Study Director

Facility Information:

Facility Name

Sun Yat-Sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gong Chen, Prof.

Phone

+86 20 87343584

chengong@sysucc.org.cn

First Name & Middle Initial & Last Name & Degree

Gong Chen, Prof.

First Name & Middle Initial & Last Name & Degree

Rong-Xin Zhang, M.D.

First Name & Middle Initial & Last Name & Degree

Yu-Hong Li, M.D.

First Name & Middle Initial & Last Name & Degree

Ling-Hneg Kong, M.D.

First Name & Middle Initial & Last Name & Degree

Zhi-qiang Wang, PhD.

First Name & Middle Initial & Last Name & Degree

Xiao-Jun Wu, M.D.

First Name & Middle Initial & Last Name & Degree

Zhi-Zhong Pan, M.D.

First Name & Middle Initial & Last Name & Degree

Yan-Hong Deng, M.D.

First Name & Middle Initial & Last Name & Degree

Hui Wang, M.D.

First Name & Middle Initial & Last Name & Degree

Meng Qiu, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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