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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02149784

Enrollment

480

Registered

2014-05-29

Start date

2015-09-30

Completion date

2019-07-31

Last updated

2017-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer Metastatic

Keywords

Metastasis colorectal cancer, Chemotherapy, Resection of primary tumor

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.

Interventions

PROCEDURESurgical resection of primary tumor

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Overall survival	3 years

Secondary

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

Countries

China

Contacts

Primary ContactGong Chen, Prof.

Chengong@sysucc.org.cn+86 20 87343584

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026