The Value of Palliative Primary Tumor Resection in Metastatic Colon Cancer

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    627
  • sponsor
    Fudan University
Updated on 24 January 2021
cancer
metastasis
systemic chemotherapy
adenocarcinoma
adenocarcinoma of colon

Summary

The aim of this trial is to evaluate the value of palliative primary tumor resection in colon cancer patients with initially unresectable metastases and a positive response to induction chemotherapy which depends on gene testing. The primary endpoint is to evaluate overall survival.

Details
Condition Surgery, Surgical aspects, Surgery, Metastatic Colon Cancer, surgical procedures, surgical treatment, surgeries, surgical procedure
Treatment mFOLFOX6, XELOX, resection of primary tumor
Clinical Study IdentifierNCT04416854
SponsorFudan University
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

years old
ECOG (Eastern Cooperative Oncology Group) 0-1 and expected survival period for 6 months or more
Pathological diagnosis of colon cancer adenocarcinoma
At least one measurable objective tumor lesions which could be evaluated
Primary and metastatic tumors exist at the same time, and distant metastases are not resectable
ANC1.5 _109/LPLT90_ 109/LHB90g/LTBI1.5(UNL); ALTAST2.5ULNCr1.0(ULN) screening within 7 days
No systemic chemotherapy
Patients with voluntary participation, and sign the informed consent

Exclusion Criteria

Operation intervention required for perforation, bleeding and obstruction of intestinal cavity
Multiple primary colorectal carcinoma
Malignant peritoneal effusion or metastatic carcinoma of the peritoneum
Uncontrolled pleural effusion
Malignant tumour of the past five years with other organizations to source, but the full treatment of cervical carcinoma in situ and except skin basal cell carcinoma and squamous cell carcinomas
With brain metastasis or meningeal metastasis
Pregnancy or breast-feeding women
Alcohol or drug addictions
There is an important organ failure or other serious diseases, including coronary artery disease, symptomatic cardiovascular disease or myocardial infarction within 12 months; serious neurological or psychiatric history; severe infection; actively disseminated vascula blood coagulation
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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