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Sponsored by: |
Heinrich-Heine University, Duesseldorf |
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Information provided by: | Heinrich-Heine University, Duesseldorf |
ClinicalTrials.gov Identifier: | NCT00791141 |
This multicenter, open-label, uncontrolled phase II trial evaluates safety and efficacy of post-operative chemoradiation in combination with cetuximab in squamous cell carcinoma of the head and neck.
Condition | Intervention | Phase |
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Head and Neck Cancer |
Drug: Cetuximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Multicenter, Open-Label Phase II Trial on Post-Surgery Chemoradiation in Combination With Cetuximab in Squamous Cell Carcinoma of the Head and Neck With High Risk of Locoregional Recurrence. |
Estimated Enrollment: | 80 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | September 2012 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Cetuximab: Experimental
Cetuximab in combination with radiotherapy, cisplatin and 5-FU. After chemoradiotherapy all patients receive a cetuximab maintenance therapy.
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Drug: Cetuximab
Loading dose prior to chemoradiotherapy 400 mg/m², followed by every week infusion of 250 mg/m² during chemoradiotherapy. After chemoradiotherapy every 2 week infusions of 500 mg/m² over 6 months.
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Advanced squamous cell carcinoma of the head and neck still has a poor prognosis and loco-regional recurrence frequently occurs. Efforts have been made to improve response rates and survival and different therapeutic regimens including concurrent chemo-radiotherapy or sequential chemo-radiotherapy have been developed.
To further increase the outcome of patients with locally advanced SCCHN effective new treatments with minimal toxicities are needed. Molecular targeted agents, which do not demonstrate overlapping toxicities with commonly used chemotherapy agents, have therefore been investigated. The EGFR is widely expressed at high levels in SSCHN and is associated with poor prognosis.
Cetuximab has already been investigated in combination with radiotherapy or chemotherapy in patients with head and neck cancer. The immunoradiotherapy was well tolerated with most of the side effects related to the high dose irradiation. The most common side effects are mucositis and dysphagia. Additionally, skin reactions appear sometimes more frequently in cetuximab administration. Grade 3 to 4 infusion reactions were observed in 3% of the patients treated with cetuximab. Based on the current promising results with RCT in patients with locally advanced head and neck cancer and clinical results with EGFR-antibodies plus RT, the present study was primarily designed to define the acute grade 3/4 toxicity.
We expect to show effective results in reducing the risk of distant metastasis, with administration of an additional six month adjuvant cetuximab treatment, in patient with recurrent SCCHN.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
To be categorized as high risk patients have to fulfil at least one of the following criterias:
Adequate renal, liver and hematological functions (within maximum 9 weeks until surgery):
Exclusion Criteria:
Other serious illness or medical conditions:
Contact: Wilfried Budach, Prof. Dr. | 0049-211-8117991 | Wilfried.Budach@uni-duesseldorf.de |
Contact: Christian Giro, Dr. | 0049-211-8117994 | Christian.Giro@med.uni-duesseldorf.de |
Germany | |
Charité University Medicine, Department of Radiotherapy and Radiological Oncology | Not yet recruiting |
Berlin, Germany, 13353 | |
Contact: Volker Budach, Prof. Dr. 0049-30-450527052 volker.budach@charite.de | |
Contact: Carmen Stromberger, Dr. 0049-30-450527052 carmen.stromberger@charite.de | |
Principal Investigator: Volker Budach, Prof. Dr. | |
Sub-Investigator: Carmen Stromberger, Dr. | |
Germany, BW | |
Department of Radiotherapeutics of the University Hospital Freiburg | Not yet recruiting |
Freiburg, BW, Germany, 79106 | |
Contact: Michael Henke, Prof. Dr. 0049-761-2709550 henke@uni-freiburg.de | |
Contact: Cornelia Kluftinger, Dr. 0049-761-2709588 cornelia.kluftinger@uniklinik-freiburg.de | |
Principal Investigator: Michael Henke, Prof. Dr. | |
Sub-Investigator: Cornelia Kluftinger, Dr. | |
Sub-Investigator: Christina Hanser, Dr. | |
Sub-Investigator: Tanja Schimek-Jasch, Dr. | |
Department of Radiological Oncology University Hospital Heidelberg | Not yet recruiting |
Heidelberg, BW, Germany, 69120 | |
Contact: Peter Debus, Prof.Dr.Dr. 0049-6221-568200 j.debus@dkfz-heidelberg.de | |
Contact: Marc Muenter, PD Dr. 0049-6221-568202 Marc.Muenter@med.uni-heidelberg.de | |
Principal Investigator: Peter Debus, Prof.Dr.Dr. | |
Sub-Investigator: Marc Muenter, PD Dr. | |
Department of Radiotherapy and Radiological Oncology University Hospital Tuebingen | Not yet recruiting |
Tuebingen, BW, Germany, 72076 | |
Contact: Stefan Welz, Dr. med. 0049-7071-2986142 Stefan.Welz@med.uni-tuebingen.de | |
Contact: Bernhard Berger, Dr. med. 0049-7071-2986742 Bernhard.Berger@med.uni-tuebingen.de | |
Principal Investigator: Stefan Welz, Dr. | |
Sub-Investigator: Bernhard Berger, Dr. | |
Department of Radiotherapy and Radiological Oncology University Hospital Ulm | Not yet recruiting |
Ulm, BW, Germany, 89091 | |
Contact: Thomas Wiegel, Prof. Dr. 0049-731-50056101 thomas.wiegel@uniklinik-ulm.de | |
Contact: Juliane Hagg 0049-731-50056144 juliane.hagg@uniklinik-ulm.de | |
Principal Investigator: Thomas Wiegel, Prof. Dr. | |
Sub-Investigator: Juliane Hagg | |
Sub-Investigator: Tanja Zunterer, Dr. | |
Germany, NW | |
Department of Radioptherapy and Radiological Oncology University Hospital Duesseldorf | Recruiting |
Duesseldorf, NW, Germany, 40225 | |
Contact: Wilfried Budach, Prof. Dr. 0049-211-8117991 Wilfried.Budach@uni-duesseldorf.de | |
Contact: Christian Giro, Dr. 0049-211-8117994 Christian.Giro@med.uni-duesseldorf.de | |
Principal Investigator: Wilfried Budach, Prof. Dr. | |
Sub-Investigator: Christian Giro, Dr. | |
Sub-Investigator: Christiane Matuschek, Dr. | |
Department of Radiotherapy and Radiological Oncology University Hospital Essen | Not yet recruiting |
Essen, NW, Germany, 45122 | |
Contact: Martin Stuschke, Prof. Dr. 0049-201-7232321 martin.stuschke@uni-essen.de | |
Contact: Sara Grehl, Dr. | |
Principal Investigator: Martin Stuschke, Prof. Dr. | |
Sub-Investigator: Sara Grehl, Dr. | |
Germany, Rheinland-Pfalz | |
Department of Radiotherapy and Radiological Oncology University Hospital Mainz | Not yet recruiting |
Mainz, Rheinland-Pfalz, Germany, 55131 | |
Contact: Heinz Schmidberger, Prof. Dr. 0049-6131-173851 Leitung@radioonkologie.klinik.uni-mainz.de | |
Contact: Walter Meyenburg, Dr. 0049-6131-172803 | |
Principal Investigator: Heinz Schmidberger, Prof. Dr. | |
Sub-Investigator: Walter Meyenburg, Dr. | |
Germany, Thueringen | |
Department of Radiotherapy and Radiological Oncology Universität Hospital Jena | Not yet recruiting |
Jena, Thueringen, Germany, 07743 | |
Contact: Thomas Wendt, Prof. Dr. 0049-3641-933214 Thomas.Wendt@med.uni-jena.de | |
Contact: Alexander Voigt, Dr. 0049-3641-934004 Alexander.Voigt@med.uni-jena.de | |
Principal Investigator: Thomas Wendt, Prof. Dr. | |
Sub-Investigator: Alexander Voigt, Dr. |
Principal Investigator: | Wilfried Budach, Prof. Dr. | Department of Radiotherapy and Radiological Oncology |
Responsible Party: | Heinrich-Heine University, Duesseldorf, Department of Radiotherapy and Radiological Oncology ( Heinrich-Heine University represented by Coordinating Investigator Prof. Dr. W. Budach ) |
Study ID Numbers: | ACCRA-HN |
Study First Received: | November 13, 2008 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00791141 |
Health Authority: | Germany: Paul-Ehrlich-Institut |
Head and Neck Cancer Radiation therapy Chemotherapy Chemoradiotherapy adjuvant cetuximab administration |
Epidermoid carcinoma Squamous cell carcinoma Head and Neck Neoplasms Cetuximab Carcinoma, squamous cell |
Carcinoma, Squamous Cell Carcinoma, squamous cell of head and neck Recurrence Carcinoma |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |