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

Phase 2
18 Years
Open (Enrolling)
Colon Cancer

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Trial Information

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

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The frequency of patients requiring adjuvant chemotherapy based on the histological evaluation of the preparation from the operation.

Outcome Time Frame:

Within 1 week after surgery

Safety Issue:


Principal Investigator

Anders Jakobsen, DMSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vejle Hospital


Denmark: Ethics Committee

Study ID:




Start Date:

April 2010

Completion Date:

December 2013

Related Keywords:

  • Colon Cancer
  • Colon cancer
  • Neoadjuvant treatment
  • KRAS mutation
  • BRAF mutation
  • PIK3CA mutation
  • Possibly avoid chemotherapy after operation
  • Colonic Neoplasms