Neoadjuvant Chemotherapy and Biological Treatment for Patients With Locally Advanced Colon Cancer

Vejle Hospital3 sites in 1 country76 target enrollmentApril 2010

Overview

Phase: Phase 2
Intervention: Oxaliplatin
Conditions: Colon Cancer
Sponsor: Vejle Hospital
Enrollment: 76
Locations: 3
Primary Endpoint: The frequency of patients requiring adjuvant chemotherapy based on the histological evaluation of the preparation from the operation.
Status: Completed
Last Updated: 10 years ago

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.

Registry

clinicaltrials.gov

Start Date

April 2010

End Date

March 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Sponsor

Responsible Party

Sponsor

•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.

•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