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| Sponsors and Collaborators: |
Austrian South Oncology Group Medical University of Graz |
|---|---|
| Information provided by: | Austrian South Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00502463 |
Purpose
The purpose of the trial is to determine the feasibility of an induction chemotherapy with radio-immunotherapy in patients with head and neck cancer stage III/IV
| Condition | Intervention |
|---|---|
|
Head and Neck Cancer |
Procedure: radio-immunotherapy |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Induction by Docetaxel/Cisplatin/5-Fluorouracil (TCF) Prior to Radiotherapy With Concomintant Cetuximab in Locally Advanced Inoperable Head and Neck Tumours - a Methodical Trial |
| Estimated Enrollment: | 50 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | December 2013 |
3 Cycles of: Docetaxel 75 mg/m2 on d1, Cisplatin 75 mg/m2 on d1, 5-FU 750 mg/m2 on days 1-5 as continuous i.v. infusion, Duration of 1 cycle: 21 days;
Followed by Cetuximab 400 mg/m2, Start of radiotherapy: 1 week after the first application of Cetuximab, During radiotherapy (35 x 2 Gy): Cetuximab 250 mg/m2 weekly, Up to 8 applications of Cetuximab.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Felix Keil, MD | +43 3842402 ext 2821 | felix.keil@lkh-leoben.at |
| Austria | |
| LKH Leoben Dept. of Hemato-Oncology | Recruiting |
| Leoben, Austria, 8700 | |
| Contact: Felix Keil, MD +43 3842401 ext 2821 felix.keil@lkh-leoben.at | |
| Contact: Christoph Tinchon, MD +43 3842401 ext 2821 christph.tinchon@lkh-leoben.at | |
| Sub-Investigator: Wolfgang Anderhuber, MD | |
| Sub-Investigator: Konstantia Gruber, MD | |
| Medical University of Graz, Dept. of Radiooncology | Not yet recruiting |
| Graz, Austria, 8036 | |
| Contact: Karin Kapp, MD +43 316 385 ext 83325 karin.kapp@meduni-graz.at | |
| Contact: Manfred Oettl, MD +43 316 385 ext 83325 manfred.oettl@meduni-graz.at | |
| Sub-Investigator: Petra Hobischer, MD | |
| Sub-Investigator: Reingard Aigner, MD | |
| Sub-Investigator: Gerhard Friedrich, MD | |
| Sub-Investigator: Heinz Stammberger, MD | |
| Sub-Investigator: Gerdard Friedrich, MD | |
| Sub-Investigator: Michaela Salzwimmer, MD | |
| Sub-Investigator: Sabine Reinisch, MD | |
| Sub-Investigator: Hellmut Samonigg, MD | |
| Sub-Investigator: Anne-Katrin Kasparek, MD | |
| LKH Feldkirch, Dept. of Radiooncology | Not yet recruiting |
| Feldkirch, Austria, 6807 | |
| Contact: Alexander de Vries, MD +43 5522 303 ext 3300 Alexander.DeVries@lkhf.at | |
| Contact: Franz Boehler, MD +43 5522 303 ext 3300 Franz.Boehler@lkhf.at | |
| Sub-Investigator: Alois Lang, MD | |
| Sub-Investigator: Wolfgang Elsaesser, MD | |
| Medical University of Vienna, Dept. of Medicine I | Not yet recruiting |
| Vienna, Austria, 1090 | |
| Contact: Gabriela Kornek, MD +43 1 40400 ext 5462 gabriela.kornek@meduniwien.ac.at | |
| Contact: Richard Poetter, MD +43 1 40400 ext 7680 richard.poetter@meduniwien.ac.at | |
| Sub-Investigator: Martin Burian, MD | |
| Sub-Investigator: Edgar Selzer, MD | |
| Sub-Investigator: Carmen Stromberger, MD | |
| Study Chair: | Felix Keil, MD | LKH Leoben, Dept. for Hemato-Oncology |
More Information
| Study ID Numbers: | ASOG-HNO1 |
| Study First Received: | July 15, 2007 |
| Last Updated: | July 16, 2007 |
| ClinicalTrials.gov Identifier: | NCT00502463 History of Changes |
| Health Authority: | Austria: Federal Ministry for Health and Women |
|
head and neck cancer, stage III/IV no prior radiotherapy of head and neck region |
|
Docetaxel Cisplatin Fluorouracil Head and Neck Neoplasms Cetuximab |
|
Neoplasms Neoplasms by Site Head and Neck Neoplasms |
