Status:
UNKNOWN
The Value of Palliative Primary Tumor Resection in Metastatic Colon Cancer
Lead Sponsor:
Fudan University
Conditions:
Metastatic Colon Cancer
Surgery
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 w...
Eligibility Criteria
Inclusion
- 75 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
- ANC≥1.5\*109/L；PLT≥90\*109/L；HB≥90g/L；TBI≤1.5(UNL); ALT、AST≤2.5ULN；Cr≤1.0(ULN) screening within 7 days
- No systemic chemotherapy
- Patients with voluntary participation, and sign the informed consent
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
627 Patients enrolled
Trial Details
Trial ID
NCT04416854
Start Date
April 1 2020
End Date
December 31 2025
Last Update
June 4 2020
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032