Trial record 13 of 900 for:
colon cancer | Open Studies
Neoadjuvant Treatment of Colon Cancer
This study is currently recruiting participants.
Verified December 2012 by Vejle Hospital
Sponsor:
Vejle Hospital
Collaborator:
Herlev Hospital
Information provided by (Responsible Party):
Vejle Hospital
ClinicalTrials.gov Identifier:
NCT01108107
First received: April 14, 2010
Last updated: December 10, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colon Cancer |
Drug: Oxaliplatin Drug: Capecitabine Biological: Panitumumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Neoadjuvant Chemotherapy and Biological Treatment for Patients With Locally Advanced Colon Cancer |
Resource links provided by NLM:
Further study details as provided by Vejle Hospital:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Recurrence free survival [ Time Frame: Up to 2 years. ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Up to 2 years. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 66 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01108107
Contacts
| Contact: Anders Jakobsen, DMsc | +45 7940 6010 | anders.jakobsen@slb.regionsyddanmark.dk |
| Contact: John Ploen, MD | +45 7940 6016 | john.ploeen@slb.regionsyddanmark.dk |
Locations
| Denmark | |
| Department of Oncology, Herlev Hospital | Recruiting |
| Herlev, Denmark, DK-2730 | |
| Contact: Benny V. Jensen, MD +45 4488 4000 ext 82297 bevi@heh.regionh.dk | |
| Contact: Ole Larsen, MD + 45 4488 4000 ext 82329 olelar02@heh.regionh.dk | |
| Principal Investigator: Benny V Jensen, MD | |
| Sub-Investigator: Ole Larsen, MD | |
| Dept. of Oncology, Hilleroed Hospital | Recruiting |
| Hilleroed, Denmark, 3400 | |
| Contact: Rahim Altaf, MD rah@noh.regionh.dk | |
| Sub-Investigator: Jesper Vilandt, MD | |
| Principal Investigator: Rahim Altaf, MD | |
| Department of Oncology, Vejle Hospital | Recruiting |
| Vejle, Denmark, DK-7100 | |
| Contact: Anders Jakobsen, DMSc +45 7940 6010 anders.jakobsen@slb.regionsyddanmark.dk | |
| Contact: John Ploen, MD +45 7940 6016 john.ploeen@slb.regionsyddanmark.dk | |
| Principal Investigator: Anders Jakobsen, MD, DMSc | |
| Sub-Investigator: John Ploen, MD | |
Sponsors and Collaborators
Vejle Hospital
Herlev Hospital
Investigators
| Principal Investigator: | Anders Jakobsen, DMSc | Vejle Hospital |
More Information
No publications provided
| Responsible Party: | Vejle Hospital |
| ClinicalTrials.gov Identifier: | NCT01108107 History of Changes |
| Other Study ID Numbers: | S-20100014 |
| Study First Received: | April 14, 2010 |
| Last Updated: | December 10, 2012 |
| Health Authority: | Denmark: Ethics Committee |
Keywords provided by Vejle Hospital:
|
Colon cancer Neoadjuvant treatment KRAS mutation |
BRAF mutation PIK3CA mutation Possibly avoid chemotherapy after operation |
Additional relevant MeSH terms:
|
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Colonic Diseases Digestive System Diseases Gastrointestinal Diseases |
Intestinal Diseases Oxaliplatin Capecitabine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013