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Neoadjuvant Treatment of Colon Cancer

This study is currently recruiting participants.
Verified December 2012 by Vejle Hospital
Sponsor:
Collaborator:
Herlev Hospital
Information provided by (Responsible Party):
Vejle Hospital
ClinicalTrials.gov Identifier:
NCT01108107
First received: April 14, 2010
Last updated: December 10, 2012
Last verified: December 2012
History of Changes
  Purpose

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.

Condition Intervention Phase
Colon Cancer
 Drug: Oxaliplatin
Drug: Capecitabine
Biological: Panitumumab
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neoadjuvant Chemotherapy and Biological Treatment for Patients With Locally Advanced Colon Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Vejle Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recurrence free survival [ Time Frame: Up to 2 years. ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Up to 2 years. ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: April 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Chemotherapy only
Chemotherapy only, if mutations in KRAS, BRAF or PIK3CA gene
 Drug: Oxaliplatin
130 mg/m2 intravenously on day 1 of a 3-weekly cycle
Drug: Capecitabine
2000 mg/m2/day (tablets) on day 1 and 14 of a 3-weekly cycle
Chemotherapy + biological treatment
Addition of biological treatment, if no mutations in KRAS, BRAF, and PIK3CA genes.
 Drug: Oxaliplatin
130 mg/m2 intravenously on day 1 of a 3-weekly cycle
Drug: Capecitabine
2000 mg/m2/day (tablets) on day 1 and 14 of a 3-weekly cycle
Biological: Panitumumab
9 mg/kg intravenously on day 1 of a 3-weekly cycle

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01108107

Contacts
Contact: Anders Jakobsen, DMsc +45 7940 6010 anders.jakobsen@slb.regionsyddanmark.dk
Contact: John Ploen, MD +45 7940 6016 john.ploeen@slb.regionsyddanmark.dk

Locations
Denmark
Department of Oncology, Herlev Hospital Recruiting
Herlev, Denmark, DK-2730
Contact: Benny V. Jensen, MD     +45 4488 4000 ext 82297     bevi@heh.regionh.dk    
Contact: Ole Larsen, MD     + 45 4488 4000 ext 82329     olelar02@heh.regionh.dk    
Principal Investigator: Benny V Jensen, MD            
Sub-Investigator: Ole Larsen, MD            
Dept. of Oncology, Hilleroed Hospital Recruiting
Hilleroed, Denmark, 3400
Contact: Rahim Altaf, MD         rah@noh.regionh.dk    
Sub-Investigator: Jesper Vilandt, MD            
Principal Investigator: Rahim Altaf, MD            
Department of Oncology, Vejle Hospital Recruiting
Vejle, Denmark, DK-7100
Contact: Anders Jakobsen, DMSc     +45 7940 6010     anders.jakobsen@slb.regionsyddanmark.dk    
Contact: John Ploen, MD     +45 7940 6016     john.ploeen@slb.regionsyddanmark.dk    
Principal Investigator: Anders Jakobsen, MD, DMSc            
Sub-Investigator: John Ploen, MD            
Sponsors and Collaborators
Vejle Hospital
Herlev Hospital
Investigators
Principal Investigator: Anders Jakobsen, DMSc Vejle Hospital
  More Information

No publications provided

Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT01108107     History of Changes
Other Study ID Numbers: S-20100014
Study First Received: April 14, 2010
Last Updated: December 10, 2012
Health Authority: Denmark: Ethics Committee

Keywords provided by Vejle Hospital:
Colon cancer
Neoadjuvant treatment
KRAS mutation
 BRAF mutation
PIK3CA mutation
Possibly avoid chemotherapy after operation

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
 Intestinal Diseases
Oxaliplatin
Capecitabine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013