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

Colorectal Cancer Metastatic Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02149784
• Other study ID #: 20140413
• 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
• 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

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms

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