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Neoadjuvant Treatment of Colon Cancer

NCT01108107 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2015-05-21

No results posted yet for this study

Summary

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.

Conditions

Interventions

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

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

Sponsors & Collaborators

  • Herlev Hospital

    collaborator OTHER

  • Vejle Hospital

    lead OTHER

Principal Investigators

  • Anders Jakobsen, DMSc · Vejle Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2013-09-30
Completion
2015-03-31

Countries

  • Denmark

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01108107 on ClinicalTrials.gov