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| Sponsor: | Grupo Español de Tratamiento de Tumores de Cabeza y Cuello |
|---|---|
| Information provided by: | Grupo Español de Tratamiento de Tumores de Cabeza y Cuello |
| ClinicalTrials.gov Identifier: | NCT00716391 |
Purpose
An Open Label Randomized, Multi-Centre Phase III Trial of TPF Chemotherapy Plus Concomitant Treatment With Cisplatin and Conventional Radiotherapy Versus TPF Chemotherapy Plus Concomitant Cetuximab and Conventional Radiotherapy in Locally Advanced, Unresectable Head and Neck Cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Other: TPF, radiotherapy and cisplatin. Other: TPF, radiotherapy and cetuximab. |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open Label Randomized, Multi-centre Phase III Trial of TPF Plus Conc. Treatment With Cisplatin and Radiotherapy Versus Conc. Cetuximab and Radiotherapy in Locally Advanced, Unresectable Head and Neck Cancer. |
| Estimated Enrollment: | 458 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Group A
TPF plus concomitant treatment with cisplatin and conventional radiotherapy.
|
Other: TPF, radiotherapy and cisplatin.
3 cycles of: cisplatin: 75mg/m2, i.v., 1 hour, once daily docetaxel: 75 mg/m2, i.v., 1 hour, once daily 5-fluorouracilo: 750 mg/m2, i.v., 24 hours, 5 days Radiotherapy: 70Gy,divided into daily doses of 2 Gray (total days:35) Cisplatin: 100 mg/m2, i.v., 1 hour, 3 days
Other Name: TPF plus radiotherapy and cisplatin
|
|
Experimental: Group B
TPF plus concomitant treatment with cetuximab and conventional radiotherapy
|
Other: TPF, radiotherapy and cetuximab.
3 cycles of: cisplatin: 75mg/m2, i.v., 1 hour, once daily docetaxel: 75 mg/m2, i.v., 1 hour, once daily 5-fluorouracilo: 750 mg/m2, i.v., 24 hours, 5 days Radiotherapy: 70Gy,divided into daily doses of 2 Gray (total days:35) Cetuximab: 400 mg/m2, i.v, 2 hours, 1 day Cetuximab: 250 mg/m2, i.v, 1 hour, 7 days
Other Name: TPF plus radiotherapy and cetuximab
|
This study is being sponsored by a cooperative medical group.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The tumor must be considered to be non-operable according to the criteria of the Northern California Oncology Group. The reason of non-surgical resection will be annotated in the CRF.
Criteria of non-surgical resection according to the NCOG:
3.1.Technically not resectable (includes: evidence of mediastinal dissemination ; fixed tumor to the clavicle, base of the cranium or cervical vertebrae; affectation of the nasopharynx).
3.2.Medical criteria based on a low surgical curability. 3.3.Medical contraindication for the surgery.
Exclusion Criteria:
Contacts and Locations| Contact: Juan C Adansa, MD | +34 923 29 11 00 ext 749 | unidad_eecc@usal.es |
| Spain | |
| Hospital Puerta del Mar | Recruiting |
| Almeria, Almería, Spain | |
| Principal Investigator: Esperanza Arriola, MD | |
| Hospital Germans Trias i Pujol | Recruiting |
| Badalona, Barcelona, Spain, 08916 | |
| Principal Investigator: Beatriz Cirauqui, MD | |
| Hospital Durán i Reynals | Recruiting |
| Hospitalet de Ll., Barcelona, Spain | |
| Principal Investigator: Ricard Mesía, MD | |
| Hospital de Manresa | Recruiting |
| Manresa, Barcelona, Spain | |
| Principal Investigator: Esther Casado | |
| Hospital Mútua de Terrassa | Recruiting |
| Terrassa, Barcelona, Spain | |
| Principal Investigator: Romà Bastús, MD | |
| Hospital Son Dureta | Recruiting |
| Palma de Mallorca, Mallorca, Spain, 07014 | |
| Principal Investigator: José Fuster, MD | |
| Hospital de Sagunto | Recruiting |
| Sagunto, Valencia, Spain | |
| Principal Investigator: José M Vicent, MD | |
| Hospital general Universitario | Recruiting |
| Alicante, Spain | |
| Principal Investigator: Juan L. Martí Ciriquián, MD | |
| Hospital Clínic i Provincial de Barcelona | Recruiting |
| Barcelona, Spain, 08036 | |
| Principal Investigator: Juan J Grau, MD | |
| Hospital de Basurto | Recruiting |
| Bilbao, Spain | |
| Principal Investigator: Elena Galve, MD | |
| Hospital General Yagüe | Recruiting |
| Burgos, Spain | |
| Principal Investigator: Carlos García Girón, MD | |
| Hospital San Pedro de Alcántara | Terminated |
| Cáceres, Spain | |
| Hospital Dr. Trueta (ICO Girona) | Recruiting |
| Girona, Spain, 17007 | |
| Principal Investigator: José Rubio, MD | |
| H. Virgen de las Nieves | Recruiting |
| Granada, Spain | |
| Principal Investigator: Antonio L Irigoyen | |
| Oncogranada | Terminated |
| Granada, Spain, 18014 | |
| Hospital General de Jaén | Not yet recruiting |
| Jaén, Spain | |
| Principal Investigator: Miguel A Moreno, MD | |
| Hospital Xeral Calde | Recruiting |
| Lugo, Spain | |
| Principal Investigator: J. Ramón Mel, MD | |
| Hospital Universitari Arnau de Vilanova | Recruiting |
| Lérida, Spain, 25198 | |
| Principal Investigator: Santiaago Miguel Sanz, MD | |
| Fundación Jiménez Díaz | Recruiting |
| Madrid, Spain | |
| Principal Investigator: Victoria Casado, MD | |
| Hospital Clínico San Carlos | Recruiting |
| Madrid, Spain, 28040 | |
| Principal Investigator: José A García, MD | |
| Hospital Universitario 12 de Octubre | Recruiting |
| Madrid, Spain, 28041 | |
| Principal Investigator: Ricardo Hitt, MD | |
| Hospital La Paz | Recruiting |
| Madrid, Spain | |
| Principal Investigator: Beatriz Castelo, MD | |
| Hospital Gregorio Marañon | Recruiting |
| Madrid, Spain | |
| Principal Investigator: Yolanda Escobar, MD | |
| Clínica Quirón | Recruiting |
| Madrid, Spain | |
| Principal Investigator: Ramón Pérez Carrión, MD | |
| Hospital Son Llàtzer | Recruiting |
| Mallorca, Spain | |
| Principal Investigator: Belén González, MD | |
| Hospital Universitario Central de Asturias | Recruiting |
| Oviedo, Spain, 33006 | |
| Principal Investigator: Enrique estrada, MD | |
| Hospital Universitario de Salamanca | Recruiting |
| Salamanca, Spain, 37007 | |
| Sub-Investigator: Juan J Cruz, MD | |
| Principal Investigator: Elvira del Barco Morillo, MD | |
| Sub-Investigator: Juan Carlos Adansa Klain, MD | |
| Hospital Universitario Marques de Valdecilla | Recruiting |
| Santander, Spain, 39008 | |
| Principal Investigator: Almudena García Castaño, MD | |
| Hospital Clínico de Santiago | Not yet recruiting |
| Santiago de Compostela, Spain | |
| Principal Investigator: Jorge J García, MD | |
| Hospital General de Segovia | Recruiting |
| Segovia, Spain | |
| Principal Investigator: Beatriz Esteban, MD | |
| Hospital La Fe | Recruiting |
| Valencia, Spain | |
| Contact: Miguel Pastor Borgoñon, MD | |
| Principal Investigator: Miguel Pastor Borgoñon, MD | |
| Hospital Arnau de Vilanova | Recruiting |
| Valencia, Spain, 46015 | |
| Principal Investigator: Oscar Juan Vidal | |
| Hospital General Universitario | Recruiting |
| Valencia, Spain | |
| Principal Investigator: Alfonso Berrocal, MD | |
| Hospital de Meixoeiro | Recruiting |
| Vigo, Spain, 36200 | |
| Principal Investigator: Carlos Grande, MD | |
| Hospital Xeral Cies | Recruiting |
| Vigo, Spain, 36024 | |
| Principal Investigator: Javier Castellanos, MD | |
| Hospital Provincial de Zamora | Recruiting |
| Zamora, Spain, 49021 | |
| Principal Investigator: Yolanda López, MD | |
| Hospital Clínico Lozano Blesa | Recruiting |
| Zaragoza, Spain | |
| Principal Investigator: Julio Lambea, MD | |
| Hospital Miguel Servet | Recruiting |
| Zaragoza, Spain | |
| Principal Investigator: Javier Martínez Trufero, MD | |
| Hospital Nuestra Señora de Sonsoles | Recruiting |
| Ávila, Spain | |
| Contact: Elena Filipovich, MD | |
| Principal Investigator: Elena Filipovich, MD | |
| Principal Investigator: | Juan J Cruz, Professor | Hospital Universitario de Salamanca |
| Principal Investigator: | Ricardo Hitt, MD | Hospital Universitario 12 de Octubre |
More Information
| Responsible Party: | Prof. Juan Jesús Cruz, Grupo Español de Tratamiento de Tumores de Cabeza y Cuello |
| ClinicalTrials.gov Identifier: | NCT00716391 History of Changes |
| Other Study ID Numbers: | TTCC-2007-01 |
| Study First Received: | July 14, 2008 |
| Last Updated: | February 12, 2011 |
| Health Authority: | Spain: Spanish Agency of Medicines |
|
Head and Neck Cancer |
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Head and Neck Neoplasms Neoplasms by Site Neoplasms Cetuximab Cisplatin |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |