Status:
UNKNOWN
Adjuvant Chemotherapy in High Risk Stage II Colon Cancer
Lead Sponsor:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Conditions:
Stage II Colon Cancer
Adjuvant Chemotherapy
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
* Benefit of adjuvant chemotherapy after curative surgery for stage II Colon Cancer is still debated. Several high-risk features may help to stratify stage II cancer patients into groups that will tru...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age 18-75 years old
- Pathologically confirmed adenocarcinoma of the colon
- Complete resection of the primary tumor without gross or microscopic evidence of residual disease
- Histologically proven stage II: T3-T4 N0
- At least one of the following factors:T4 staging,Number of examined lymph nodes \< 12,poor differentiation (except MSI-H),LVI or PNI,tumor perforation or occlusion
- Treatment within 7 weeks following surgery
- ECOG PS 0-1
- No prior chemo, immuno or radiotherapy
- Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study.
- Exclusion criteria
- Have a birth plan during the clinical trial;
- Severe cardiovascular diseases such as cerebrovascular accidents occurring within 6 months, myocardial infarction, hypertension that cannot be controlled after drug intervention, unstable angina pectoris, heart failure (NYHA 2-4), and arrhythmia requiring drugs Intervention;
- Dementia, mental state changes or any mental illness that may interfere with understanding or making informed consent or completing a questionnaire;
- Subjects with ≥1 peripheral neuropathy according to CTCAE V version 4.03;
- Allergy or hypersensitivity history of the drug or drug ingredient used in this test;
- Excluding other malignant tumors, cured basal cell carcinoma of the skin or squamous cell carcinoma of the skin or any other part of the carcinoma in situ;
- Have received any other test drug treatment or participated in another interventional clinical trial within 30 days of the screening period;
- The investigator believes that it is not suitable for inclusion.
Exclusion
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
962 Patients enrolled
Trial Details
Trial ID
NCT04303429
Start Date
August 1 2020
End Date
January 1 2025
Last Update
April 8 2020
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