Status:
UNKNOWN
A Phase Ⅱ Study of XELOX Chemotherapy With or Without Surgery of Primary Lesion for Colon Cancer Patients
Lead Sponsor:
Fudan University
Conditions:
Metastatic Colon Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The primary endpoint is to evaluate the TFS (time to failure of strategy).
Detailed Description
The primary endpoint is to evaluate the time to failure of strategy, that is the second progression time after induction therapy by the use of XELOX regimen, comparing XELOX regimen chemotherapy combi...
Eligibility Criteria
Inclusion
- 18\~75 ears old
- Pathological diagnosis of colon cancer adenocarcinoma
- No systemic chemotherapy for metastatic tumors
- ECOG (Eastern Cooperative Oncology Group) 0-1 and expected survival period for 6 months or more
- At least one measurable objective tumor lesions
- 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
- Primary and metastatic tumors exist at the same time, and distant metastases are not resectable
- Patients with voluntary participation, and sign the informed consent
Exclusion
- Operation intervention required for perforation, bleeding and obstruction of intestinal cavity
- With uncontrollable large pleural or peritoneal effusion
- Alcohol or drug addictions
- 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
- Multiple primary colorectal carcinoma
- Pregnancy or breast-feeding women
- 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 :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2017
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT02291744
Start Date
October 1 2014
End Date
October 1 2017
Last Update
November 11 2015
Active Locations (1)
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1
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China, 200032