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Neoadjuvant Treatment of Colon Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Neoadjuvant Treatment of Colon Cancer

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

NCT01108107•Vejle Hospital

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

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

Locations (3)

Department of Oncology, Herlev Hospital

Herlev, Denmark

Dept. of Oncology, Hilleroed Hospital

Hilleroed, Denmark

Department of Oncology, Vejle Hospital

Vejle, Denmark

Key Dates

Start Date

April 1, 2010

Primary Completion Date

September 1, 2013

Completion Date

March 1, 2015

Last Updated

May 21, 2015

Enrollment

ACTUAL participants

Conditions

Colon Cancer

Interventions

Oxaliplatin

DRUG

Capecitabine

DRUG

Oxaliplatin

DRUG

Capecitabine

DRUG

Panitumumab

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 21, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Neoadjuvant Treatment of Colon Cancer

Inclusion Criteria

Exclusion Criteria

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