Neoadjuvant Treatment of Colon Cancer

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will investigate

• the effect of preoperative combination chemotherapy in patients with locally advanced colon cancer with mutation in the KRAS, BRAF or PIK3CA gene

• the effect of preoperative combination chemotherapy in combination with biological treatment in patients without mutation in the KRAS, BRAF or PIK3CA gene.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vejle Hospital
• Collaborator: Herlev Hospital
• Treatments: Capecitabine; Oxaliplatin; Panitumumab

Criteria

Inclusion Criteria:

• Histologically verified locally advanced T3 or T4 colon cancer assessed by CT scan

• Analysis of KRAS, BRAF, PIK3CA

• Age ≥18 år

• Performance status ≤ 2

• Hematology

• ANC ≥ 1.5x10^9/l. Thrombocytes ≥ 100x10^9/l.

• Biochemistry

• Bilirubinaemia ≤ 3 x UNL. ALAT ≤ 5 x UNL

• Consent to translational research

• Fertile women must present a negative pregnancy test and use secure birth control during and 3 months after treatment.

• Written and orally informed consent.

Exclusion Criteria:

• Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment, active severe infections or other concurrent disease.

• Peripheral neuropathy NCI grade >1

• Other malignant disease within 5 years prior to enrollment, except basal cell squamous carcinoma of the skin and cervical carcinoma-in-situ

• Other investigational treatment within 30 days prior to treatment start

• History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.

• Bleeding tumors

• Hypersensitivity to one or more of the substances