Colon cancer MedDRA version: 21.0 Level: LLT Classification code 10009951 Term: Colon cancer NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Xeloda
Pharmaceutical Form: Tablet
INN or Proposed INN: CAPECITABINE
Other descriptive name: CAPECITABINE
Trade Name: Oxaliplatin "Hospira"
Pharmaceutical Form: Concentrate for solution f
Sponsors
Vejle Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically verified locally advanced T3 (ETI > 5 mm) or T4 colon cancer assessed by CT scan. • Age = 18 years • PS 0-2. • Hematology ANC =1.5x10^9/l. Thrombocytes = 100x10^9/l. • Biochemistry Bilirubinemia = 3 x upper normal level. ALAT = 5 x upper normal value • Consent to translational research • Fertile women must present a negative pregnancy test and use secure contraceptives during and 3 months after treatment. • Written and orally informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: • Patients with distant metastases. • Acute operation • Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = 1 year before inclusion. • Active, serious infection or other serious disease. • Peripheral neuropathy NCI grade > 1 • Other malignant disease within 5 years prior to study enrollment, except basocellular or squamous skin cancer and carcinoma in situ cervicis uteri. • Other investigational treatment within 30 days prior to treatment start. • Hypersensitivity to one or more of the active or auxiliary substances.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of neoadjuvant chemotherapy in locally advanced colon cancer as estimated by disease free survival.;Secondary Objective: Not applicable;Primary end point(s): Two-year disease free survival.;Timepoint(s) of evaluation of this end point: Every 3 months the first year. Every 6 months the second year. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 Rate of patients fulfilling the criteria for adjuvant chemotherapy. 2 Overall survival (OS) 3 Response to neoadjuvant chemotherapy as evaluated at the operation.;Timepoint(s) of evaluation of this end point: 1. At time of operation 2. Every 3 months the first year. Every 6 months the second year. | — |
Countries
Denmark, Sweden
Outcome results
None listed