Colon Cancer Clinical Trial
Official title:
Neoadjuvant Chemotherapy and Biological Treatment for Patients With Locally Advanced Colon Cancer
Verified date | March 2014 |
Source | Vejle Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 76 |
Est. completion date | March 2015 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Oncology, Herlev Hospital | Herlev | |
Denmark | Dept. of Oncology, Hilleroed Hospital | Hilleroed | |
Denmark | Department of Oncology, Vejle Hospital | Vejle |
Lead Sponsor | Collaborator |
---|---|
Vejle Hospital | Herlev Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The frequency of patients requiring adjuvant chemotherapy based on the histological evaluation of the preparation from the operation. | Within 1 week after surgery | No | |
Secondary | Recurrence free survival | Up to 2 years. | No | |
Secondary | Overall survival | Up to 2 years. | No |
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