Neoadjuvant Treatment of Colon Cancer

Vejle Hospital

Status and phase: Completed; Phase 2

Conditions: Colon Cancer

Treatments: Drug: Oxaliplatin; Biological: Panitumumab; Drug: Capecitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT01108107

S-20100014

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Chemotherapy only

Other group

Description:

Chemotherapy only, if mutations in KRAS, BRAF or PIK3CA gene

Treatment:

Drug: Capecitabine

Drug: Oxaliplatin

Drug: Capecitabine

Drug: Oxaliplatin

Chemotherapy + biological treatment

Other group

Description:

Addition of biological treatment, if no mutations in KRAS, BRAF, and PIK3CA genes.

Treatment:

Drug: Capecitabine

Drug: Oxaliplatin

Drug: Capecitabine

Biological: Panitumumab

Drug: Oxaliplatin