Effectiveness Study of Resection of Primary Tumor in Stag... | NCT02149784

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

NCT02149784

Sponsor

Sun Yat-sen University

Status

Unknown status

Last Update Posted

Apr 27, 2017Actual

Enrollment

480Estimated

Phase

Phase 3

Conditions

Colorectal Cancer Metastatic

Interventions

Surgical resection of primary tumor

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Jul 2018Estimated

Completion Date

Jul 2019Estimated

First Submitted Date

May 18, 2014

First Submission Date that Met QC Criteria

May 25, 2014

First Posted Date

May 29, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2017

Last Update Posted Date

Apr 27, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

480Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Surgical resection of primary tumor	Procedure	Surgical resection of primary tumor of mCRC patients who were respond to first line chemotherapy'	Surgical treatment group

Measure	Description	Time Frame
Overall survival		3 years

Measure	Description	Time Frame
Number of Participants with Adverse Events both in surgery group and chemotherapy group		2 years

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gong Chen, Prof.	Contact	+86 20 87343584		Chengong@sysucc.org.cn

Overall Officials

Name	Affiliation	Role
Gong Chen, Prof.	Sun Yat-Sen University Cancer Center	Principal Investigator
Zhi-zhong Pan, Prof.	Sun Yat-Sen University Cancer Center	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sun Yat-Sen University Cancer Center	Recruiting	Guangzhou	Guangdong	510060	China