Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
76 participants
INTERVENTIONAL
2010-04-30
2015-03-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Chemotherapy only
Chemotherapy only, if mutations in KRAS, BRAF or PIK3CA gene
Oxaliplatin
130 mg/m2 intravenously on day 1 of a 3-weekly cycle
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.
Oxaliplatin
130 mg/m2 intravenously on day 1 of a 3-weekly cycle
Capecitabine
2000 mg/m2/day (tablets) on day 1 and 14 of a 3-weekly cycle
Panitumumab
9 mg/kg intravenously on day 1 of a 3-weekly cycle
Interventions
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Oxaliplatin
130 mg/m2 intravenously on day 1 of a 3-weekly cycle
Capecitabine
2000 mg/m2/day (tablets) on day 1 and 14 of a 3-weekly cycle
Oxaliplatin
130 mg/m2 intravenously on day 1 of a 3-weekly cycle
Capecitabine
2000 mg/m2/day (tablets) on day 1 and 14 of a 3-weekly cycle
Panitumumab
9 mg/kg intravenously on day 1 of a 3-weekly cycle
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Herlev Hospital
OTHER
Vejle Hospital
OTHER
Responsible Party
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Principal Investigators
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Anders Jakobsen, DMSc
Role: PRINCIPAL_INVESTIGATOR
Vejle Hospital
Locations
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Department of Oncology, Herlev Hospital
Herlev, , Denmark
Dept. of Oncology, Hilleroed Hospital
Hilleroed, , Denmark
Department of Oncology, Vejle Hospital
Vejle, , Denmark
Countries
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References
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Dam C, Lund-Rasmussen V, Ploen J, Jakobsen A, Rafaelsen SR. Computed tomography assessment of early response to neoadjuvant therapy in colon cancer. Dan Med J. 2015 Jul;62(7):A5103.
Other Identifiers
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S-20100014
Identifier Type: -
Identifier Source: org_study_id
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