Neoadjuvant Chemotherapy Versus Standard Treatment in Patients With Locally Advanced Colon Cancer

• Status: Active, not recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vejle Hospital
• Treatments: Capecitabine; Oxaliplatin

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.

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.