Chemotherapy in locally advanced colon cancer
Phase 3
Recruiting
- Conditions
- Cancer of the large intestine.Malignant neoplasm of colon
- Registration Number
- IRCT20130819014404N2
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 58
Inclusion Criteria
Adnocarcinoma
Stage T3 with lymph node involvement and T4
Non metastatic
Primary tumor without complications which needs surgery (i.e. obstruction, perforation, bleeding)
Age between 18-75
Functional status ECOG between 0-1
Exclusion Criteria
Contraindication for receiving contrast for imaging
Major surgery in less than 28 days prior to recruiting to the study
Co-existence of other cancers
Past medical history of other cancers
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease Free Survival. Timepoint: One year after intervention. Method of measurement: No relapse of cancer.;Histological response and down staging of tumor. Timepoint: After surgery. Method of measurement: Pathological and radiological examination.
- Secondary Outcome Measures
Name Time Method Overall survival. Timepoint: 1 year after surgery. Method of measurement: The patient is alive.;The safety and tolerably of chemotherapy before surgery. Timepoint: 60-day mortality after surgery. Method of measurement: The patient is alive.;Quality of life. Timepoint: At baseline, 6 months and one year after the completion of the study. Method of measurement: ?Questionnaires EORTC QLQ-CR29 and EORTC QLQ-C30.