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 19 February 2024
cancer
metastasis
adenocarcinoma
induction chemotherapy
primary tumor
systemic chemotherapy
colon cancer
tumor resection
adenocarcinoma of colon
metastatic colon cancer
adenocarcinoma of the colon
mfolfox6
xelox
stage iv colon cancer

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
Age 18-75 years
Treatment XELOX, resection of primary tumor, mFOLFOX6
Clinical Study IdentifierNCT04416854
SponsorFudan University
Last Modified on19 February 2024

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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