Neoadjuvant Chemotherapy Versus Standard Treatment in Patients With Locally Advanced Colon Cancer
Overview
- Phase
- Phase 3
- Intervention
- Capecitabine
- Conditions
- Colon Cancer
- Sponsor
- Vejle Hospital
- Enrollment
- 250
- Locations
- 9
- Primary Endpoint
- Two-year disease free survival
- Status
- Active, Not Recruiting
- Last Updated
- last month
Overview
Brief Summary
The purpose of this study is to compare 3 cycles of neoadjuvant (preoperative) chemotherapy + operation with the standard treatment of locally advanced colon cancer, which is operation + 8 cycles of (adjuvant) chemotherapy.
Patients receiving neoadjuvant chemotherapy may not need adjuvant chemotherapy after the operation and, if this is the case, they will be spared of 5 cycles of chemotherapy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically verified locally advanced T3 (ETI \> 5 mm) or T4 colon cancer assessed by CT scan.
- •Age ≥ 18 years
- •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.
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.
Arms & Interventions
A, Conventional treatment
Operation + 4 or 8 cycles of adjuvant chemotherapy, if indicated.
Intervention: Capecitabine
A, Conventional treatment
Operation + 4 or 8 cycles of adjuvant chemotherapy, if indicated.
Intervention: Oxaliplatin
B, Neoadjuvant chemotherapy
3 cycles of neoadjuvant chemotherapy + operation. Adjuvant chemotherapy only if indicated.
Intervention: Capecitabine
B, Neoadjuvant chemotherapy
3 cycles of neoadjuvant chemotherapy + operation. Adjuvant chemotherapy only if indicated.
Intervention: Oxaliplatin
Outcomes
Primary Outcomes
Two-year disease free survival
Time Frame: 2 years after completed study treatment
Secondary Outcomes
- Rate of patients fulfilling the criteria for adjuvant chemotherapy(6, 12, 18, and 24 months after completed study treatment)