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Sponsors and Collaborators: |
Austrian Breast & Colorectal Cancer Study Group Sanofi-Synthelabo Hoffmann-La Roche |
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Information provided by: | Austrian Breast & Colorectal Cancer Study Group |
ClinicalTrials.gov Identifier: | NCT00297141 |
Rate of T-downstaging (Reduction of the T-stadium) at the time of final surgery following the preoperative combined radiochemotherapy (chemotherapy:
Oxaliplatin, Capecitabine) Evaluation of the toxicity grade III and IV of the therapy scheme
Condition | Intervention | Phase |
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Rectal Cancer |
Drug: Capecitabine Drug: Oxaliplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Preoperative Combined Radiochemotherapy for Patients With Newly Diagnosed, Primary Operable and Locally Advanced Rectal Carcinoma (cT3, Nx, M0) of the Lower and Middle Rectum |
Estimated Enrollment: | 60 |
Study Start Date: | October 2004 |
Estimated Study Completion Date: | March 2006 |
About 60 patients with locally advanced rectal carcinoma (cT3, Nx, M0) of the lower and middle rectum will be recruited.
The radiotherapy is an essential part of therapy of the advanced rectal carcinoma and the additional administration of a chemotherapy will positively influence the effect of the therapy (downstaging-rate, rate of distant metastases, survival-rate). Probably a downsizing and downstaging (as per literature and by own experience) can be reached with an preoperative combined radiochemotherapy.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Austria | |
Paracelsus Medical University Salzburg - Oncology | |
Salzburg, Austria, 5020 | |
Medical University of Vienna, Radiotherapy | |
Vienna, Austria, 1090 | |
Austria, Carinthia | |
Hospital BHB St. Veit/Glan, Surgery | |
St. Veit a. d. Glan, Carinthia, Austria, 9330 | |
Austria, Lower Austria | |
Hospital Wiener Neustadt | |
Wiener Neustadt, Lower Austria, Austria, 2700 | |
Austria, Styria | |
Medical University of Graz, Oncology | |
Graz, Styria, Austria, 8036 | |
State Hospital Leoben, Surgery | |
Leoben, Styria, Austria, 8700 | |
Austria, Tyrol | |
Medical University of Innsbruck, Surgery | |
Innsbruck, Tyrol, Austria, 6020 | |
Austria, Upper Austria | |
Hospital Kreuzschwestern Wels | |
Wels, Upper Austria, Austria, 4600 | |
Hospital BHS Linz | |
Linz, Upper Austria, Austria, 4020 | |
Austria, Vorarlberg | |
State Hospital, Radiooncology | |
Feldkirch, Vorarlberg, Austria, 6807 |
Principal Investigator: | Dietmar Oefner, MD | Austrian Breast & Colorectal Cancer Study Group |
Principal Investigator: | Alexander de Vries, MD | Austrian Breast & Colorectal Cancer Study Group |
Principal Investigator: | Josef Thaler, MD | Austrian Breast & Colorectal Cancer Study Group |
Study ID Numbers: | ABCSG 95 / TAKO 05, Studie 95, EudraCT: 2004-002358-72 |
Study First Received: | February 27, 2006 |
Last Updated: | January 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00297141 History of Changes |
Health Authority: | Austria: Federal Ministry for Health and Women |
Preoperative Radiochemotherapy Newly Diagnosed Primary Operable Locally Advanced Rectal Carcinoma T3 |
Lower Rectum Middle Rectum ABCSG TAKO 95 05 |
Antimetabolites Capecitabine Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Rectal Neoplasm Intestinal Diseases Rectal Diseases |
Intestinal Neoplasms Carcinoma Oxaliplatin Digestive System Diseases Rectal Cancer Gastrointestinal Neoplasms Colorectal Neoplasms Neoplasms, Glandular and Epithelial |
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Neoplasms by Histologic Type Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Rectal Neoplasms Gastrointestinal Diseases Intestinal Diseases Rectal Diseases |
Pharmacologic Actions Intestinal Neoplasms Carcinoma Oxaliplatin Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Colorectal Neoplasms Neoplasms, Glandular and Epithelial |