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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2019-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Colorectal Cancer Metastatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgical treatment group

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

Group Type EXPERIMENTAL

Surgical resection of primary tumor

Intervention Type PROCEDURE

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

Chemotherapy group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Surgical resection of primary tumor

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No