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

NCT02149784 | Unknown Phase 3 DMC

• 1 other identifier: 20140413
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer Metastatic

Keywords

Metastasis colorectal cancer; Chemotherapy; Resection of primary tumor

Outcome Measures

Primary Outcomes (1)

• Overall survival

  3 years

Secondary Outcomes (1)

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

  2 years

Study Arms (2)

Surgical treatment group

EXPERIMENTAL

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

Procedure: Surgical resection of primary tumor

Chemotherapy group

NO INTERVENTION

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

Interventions

Surgical resection of primary tumor PROCEDURE

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

Surgical treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Study Officials

• Gong Chen, Prof.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

• Zhi-zhong Pan, Prof.

  Sun Yat-sen University

  STUDY CHAIR

• De-Sen Wan, Prof.

  Sun Yat-sen University

  STUDY DIRECTOR

Central Study Contacts

Gong Chen, Prof.

CONTACT

+86 20 87343584; Chengong@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sun Yat-Sen University Cancer Center

Study Record Dates

• First Submitted: May 18, 2014
• First Posted: May 29, 2014
• Study Start: September 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2019
• Last Updated: April 27, 2017

Record last verified: 2017-04

Locations

CN (1)