Neoadjuvant Treatment of Colon Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Colon Cancer

Intervention / Treatment
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* Drug: Oxaliplatin
* Drug: Capecitabine
* Drug: Oxaliplatin
* Drug: Capecitabine
* Biological: Panitumumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Chemotherapy only<br>Chemotherapy only, if mutations in KRAS, BRAF or PIK3CA gene | Drug: Oxaliplatin<br>* 130 mg/m2 intravenously on day 1 of a 3-weekly cycle<br>Drug: Capecitabine<br>* 2000 mg/m2/day (tablets) on day 1 and 14 of a 3-weekly cycle<br>|
| Other: Chemotherapy + biological treatment<br>Addition of biological treatment, if no mutations in KRAS, BRAF, and PIK3CA genes. | Drug: Oxaliplatin<br>* 130 mg/m2 intravenously on day 1 of a 3-weekly cycle<br>Drug: Capecitabine<br>* 2000 mg/m2/day (tablets) on day 1 and 14 of a 3-weekly cycle<br>Biological: Panitumumab<br>* 9 mg/kg intravenously on day 1 of a 3-weekly cycle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The frequency of patients requiring adjuvant chemotherapy based on the histological evaluation of the preparation from the operation. |  | Within 1 week after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence free survival |  | Up to 2 years. | 
| Overall survival |  | Up to 2 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colon cancer, Neoadjuvant treatment, KRAS mutation, BRAF mutation, PIK3CA mutation, Possibly avoid chemotherapy after operation