Neoadjuvant Treatment of Colon Cancer

May 20, 2015 updated by: Vejle Hospital

Neoadjuvant Chemotherapy and Biological Treatment for Patients With Locally Advanced 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herlev, Denmark, DK-2730
        • Department of Oncology, Herlev Hospital
      • Hilleroed, Denmark, 3400
        • Dept. of Oncology, Hilleroed Hospital
      • Vejle, Denmark, DK-7100
        • Department of Oncology, Vejle Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Within 1 week after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Recurrence free survival
Time Frame: Up to 2 years.
Up to 2 years.
Overall survival
Time Frame: Up to 2 years.
Up to 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vejle Hospital

Collaborators

Herlev Hospital

Investigators

  • Principal Investigator: Anders Jakobsen, DMSc, Vejle Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

April 14, 2010

First Submitted That Met QC Criteria

April 20, 2010

First Posted (Estimate)

April 21, 2010

Study Record Updates

Last Update Posted (Estimate)

May 21, 2015

Last Update Submitted That Met QC Criteria

May 20, 2015

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-20100014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colon Cancer

Clinical Trials on Oxaliplatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe