Preoperative Chemoradiation With Capecitabine and Cetuximab
This study has been completed.
Sponsor:
Austrian Breast & Colorectal Cancer Study Group
Collaborators:
Hoffmann-La Roche
Merck Gesellschaft mbH, Austria
Information provided by (Responsible Party):
Austrian Breast & Colorectal Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00297128
First received: February 27, 2006
Last updated: December 29, 2011
Last verified: December 2011
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Purpose
- feasibility and tolerance of preoperative therapy with Cetuximab in combination with Capecitabine and radiotherapy for patients with locally advanced operable rectal carcinoma
- collection of response rate (T-downstaging, pathological complete remission), correlation of responsiveness with EGFR-status
| Condition | Intervention | Phase |
|---|---|---|
|
Rectal Cancer |
Drug: Capecitabine Drug: Cetuximab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Preoperative Chemoradiation With Capecitabine and Cetuximab Within a Multidisciplinary Therapeutic Approach in Patients With Operable T3-T4 Rectal Cancer: a Phase II Study |
Resource links provided by NLM:
Further study details as provided by Austrian Breast & Colorectal Cancer Study Group:
Primary Outcome Measures:
- feasibility and tolerance of preoperative therapy with Cetuximab in combination with Capecitabine and radiotherapy for patients with locally advanced operable rectal carcinoma [ Time Frame: descriptive evaluation ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- collection of response rate (T-downstaging, pCR), correlation of responsiveness with EGFR-status [ Time Frame: description evaluation ] [ Designated as safety issue: No ]
| Enrollment: | 31 |
| Study Start Date: | October 2005 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Drug: Capecitabine
825 mg/m2 bid (on each therapy day of first 4 therapy weeks)
Other Name: Xeloda
Drug: Cetuximab
400mg/m2 week 1, 250mg/m2 week 2-4
Other Name: Erbitux
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age: 18-80
- bioptical confirmed adenocarcinoma of the rectum in operable T3-T4NxM0 status. In spite of infiltration of the neighbouring organs the tumor has to be basically surgically complete resectable
- no former chemotherapy, radiotherapy of pelvis or abdomen and/or tumor resection of a rectum carcinoma
- WHO performance status 0-2
- adequate bone marrow reserve (granulocytes - not more than 1.500/µl; thrombocytes - not more than 100.000/µl)
- adequate hepatic function ( bilirubin - not more than 1.5 x ULN; GOT and GPT - not more than 3.5 x ULN)
- adequate renal function (creatinin - not more than 1.5 mg/dl)
- women of childbearing potential: exclusion of pregnancy (negative urin or serum pregnancy test)
- willingness of women of childbearing potential and accordingly of potent men to use approved contraceptives (e.g. birth-control pill, loop, condom) during and at least 3 month after conclusion of the study
- life expectancy of at least 3 month
- signed Informed Consent before recruitment
- exclusion of distant metastases at the time of recruitment
Exclusion Criteria:
- former radiotherapy of pelvis or abdomen
- former chemotherapy
- any other kind of malign tumor (except adequate treated skin basalioma or in situ cervical carcinoma) in the last 5 years
- general contraindication or known hypersensitivity against Cetuximab and/or Capecitabine
- Non malign disease, if there is a contraindication with radiotherapy or chemotherapy with Cetuximab and Capecitabine or a resection of the rectum: high-graded cardiac insufficiency, angina pectoris, hypertension or arrhythmia, hepatic disease, significant neurological or psychiatric disorders
- florid, serious infections at the time of recruitment
- legally limited contractual capability or evidence of neurological or psychiatric disease, if it will constrict the patients compliance in the opinion of the investigator
- evidence of lacking cooperation of the patient
- pregnant or breast feeding women
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00297128
Locations
| Austria | |
| Hospital BHB St. Veit/Glan, Surgery | |
| St. Veit a. d. Glan, Carinthia, Austria, 9330 | |
| Hospital Wiener Neustadt, Surgery | |
| Wiener Neustadt, Lower Austria, Austria, 2700 | |
| Medical University of Graz, Oncology | |
| Graz, Styria, Austria, 8036 | |
| State Hospital Leoben | |
| Leoben, Styria, Austria, 8700 | |
| Medical University of Innsbruck, Surgery | |
| Innsbruck, Tyrol, Austria, 6020 | |
| Hospital BHS Linz, Radiooncology | |
| Linz, Upper Austria, Austria, 4010 | |
| Klinikum Wels-Grieskirchen | |
| Wels, Upper Austria, Austria, 4600 | |
| State Hospital Feldkirch | |
| Feldkirch, Vorarlberg, Austria, 6807 | |
| Paracelsus Medical University Salzburg - Oncology | |
| Salzburg, Austria, 5020 | |
| Medical University of Vienna, Radiotherapy | |
| Vienna, Austria, 1090 | |
Sponsors and Collaborators
Austrian Breast & Colorectal Cancer Study Group
Hoffmann-La Roche
Merck Gesellschaft mbH, Austria
Investigators
| Principal Investigator: | Josef Thaler, MD | Austrian Breast & Colorectal Cancer Study Group |
| Principal Investigator: | Joerg Tschmelitsch, MD | Austrian Breast & Colorectal Cancer Study Group |
| Principal Investigator: | Alexander de Vries, MD | Austrian Breast & Colorectal Cancer Study Group |
More Information
Additional Information:
No publications provided
| Responsible Party: | Austrian Breast & Colorectal Cancer Study Group |
| ClinicalTrials.gov Identifier: | NCT00297128 History of Changes |
| Other Study ID Numbers: | ABCSG R03 (96) / TAKO 06 |
| Study First Received: | February 27, 2006 |
| Last Updated: | December 29, 2011 |
| Health Authority: | Austria: Federal Office for Safety in Health Care |
Keywords provided by Austrian Breast & Colorectal Cancer Study Group:
|
pilot study rectal cancer phase II preoperative chemoradiation capecitabine cetuximab |
operable T4 ABCSG TAKO R03 96 06 |
Additional relevant MeSH terms:
|
Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Capecitabine |
Fluorouracil Cetuximab Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 13, 2013