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OpenTrials
Completed

NCT Number: NCT01108107

Neoadjuvant Treatment of Colon Cancer

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.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Oncology, Herlev Hospital, Herlev, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxaliplatin

Drug

130 mg/m2 intravenously on day 1 of a 3-weekly cycle

Capecitabine

Drug

2000 mg/m2/day (tablets) on day 1 and 14 of a 3-weekly cycle

Panitumumab

Biological

9 mg/kg intravenously on day 1 of a 3-weekly cycle

Primary outcomes

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

    Time frame: Within 1 week after surgery

Secondary outcomes

  1. Recurrence free survival

    Time frame: Up to 2 years.

  2. Overall survival

    Time frame: Up to 2 years.

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Collaborators

  • Herlev Hospital

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2015
First posted
Apr 21, 2010
Registry last updated
May 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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