Neoadjuvant Treatment of Colon Cancer

Phase 2

Completed

• Conditions: Colon Cancer
• Interventions: Drug: Oxaliplatin; Drug: Capecitabine; Biological: Panitumumab

• Registration Number: NCT01108107
• Lead Sponsor: Vejle Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-14
• Study First Submitted QC: 2010-04-20
• Study First Posted: 2010-04-21
• Primary Completion: 2013-09
• Status Verified: 2014-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-05-20
• Last Update Posted: 2015-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Chemotherapy + biological treatment	Capecitabine	Addition of biological treatment, if no mutations in KRAS, BRAF, and PIK3CA genes.
Chemotherapy only	Oxaliplatin	Chemotherapy only, if mutations in KRAS, BRAF or PIK3CA gene
Chemotherapy + biological treatment	Oxaliplatin	Addition of biological treatment, if no mutations in KRAS, BRAF, and PIK3CA genes.
Chemotherapy only	Capecitabine	Chemotherapy only, if mutations in KRAS, BRAF or PIK3CA gene
Chemotherapy + biological treatment	Panitumumab	Addition of biological treatment, if no mutations in KRAS, BRAF, and PIK3CA genes.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Recurrence free survival	Up to 2 years.
Overall survival	Up to 2 years.

Trial Locations

Locations (3)

Dept. of Oncology, Hilleroed Hospital; 🇩🇰 Hilleroed, Denmark

Department of Oncology, Vejle Hospital; 🇩🇰 Vejle, Denmark

Department of Oncology, Herlev Hospital; 🇩🇰 Herlev, Denmark