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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: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| 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 |
|---|---|
|
Group A: Active Comparator
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
|
|
Group B: Experimental
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
|
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 Clínic i Provincial de Barcelona | Active, not recruiting |
| Barcelona, Spain, 08036 | |
| Hospital de Basurto | Not yet recruiting |
| Bilbao, Spain | |
| Principal Investigator: Elena Galve, MD | |
| Hospital General Yagüe | Active, not recruiting |
| Burgos, Spain | |
| Hospital San Pedro de Alcántara | Active, not recruiting |
| Cáceres, Spain | |
| Hospital Dr. Trueta (ICO Girona) | Recruiting |
| Girona, Spain, 17007 | |
| Principal Investigator: José Rubio, MD | |
| Oncogranada | Active, not recruiting |
| Granada, Spain, 18014 | |
| H. Virgen de las Nieves | Recruiting |
| Granada, Spain | |
| Principal Investigator: Antonio L Irigoyen | |
| Hospital Son Llàtzer | Recruiting |
| Mallorca, Spain | |
| Principal Investigator: Belén González, MD | |
| Hospital Xeral Calde | Recruiting |
| Lugo, Spain | |
| Principal Investigator: J. Ramón Mel, MD | |
| Hospital Universitario 12 de Octubre | Recruiting |
| Madrid, Spain, 28041 | |
| Principal Investigator: Ricardo Hitt, MD | |
| Hospital Clínico San Carlos | Not yet recruiting |
| Madrid, Spain, 28040 | |
| Principal Investigator: José A García, MD | |
| Fundación Jiménez Díaz | Not yet recruiting |
| Madrid, Spain | |
| Principal Investigator: Victoria Casado, MD | |
| Clínica Quirón | Not yet recruiting |
| Madrid, Spain | |
| Principal Investigator: Ramón Pérez Carrión, MD | |
| Hospital General de Jaén | Not yet recruiting |
| Jaén, Spain | |
| Principal Investigator: Miguel A Moreno, MD | |
| Hospital Universitario de Salamanca | Recruiting |
| Salamanca, Spain, 37007 | |
| Principal Investigator: Juan J Cruz, MD | |
| Hospital Clínico de Santiago | Not yet recruiting |
| Santiago de Compostela, Spain | |
| Principal Investigator: Jorge J García, MD | |
| Hospital General de Segovia | Active, not recruiting |
| Segovia, Spain | |
| Hospital de Meixoeiro | Active, not recruiting |
| Vigo, Spain, 36200 | |
| Hospital Miguel Servet | Recruiting |
| Zaragoza, Spain | |
| Principal Investigator: Javier Martínez Trufero, MD | |
| Hospital Provincial de Zamora | Active, not recruiting |
| Zamora, Spain, 49021 | |
| Hospital Clínico Lozano Blesa | Active, not recruiting |
| Zaragoza, Spain | |
| Hospital Xeral Cies | Recruiting |
| Vigo, Spain, 36024 | |
| Principal Investigator: Javier Castellanos, MD | |
| Spain, Almería | |
| Hospital Puerta del Mar | Not yet recruiting |
| Almeria, Almería, Spain | |
| Principal Investigator: Esperanza Arriola, MD | |
| Spain, Barcelona | |
| 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 Mútua de Terrassa | Active, not recruiting |
| Terrassa, Barcelona, Spain | |
| Hospital de Manresa | Recruiting |
| Manresa, Barcelona, Spain | |
| Principal Investigator: Esther Casado | |
| Spain, Mallorca | |
| Hospital Son Dureta | Recruiting |
| Palma de Mallorca, Mallorca, Spain, 07014 | |
| Principal Investigator: José Fuster, MD | |
| Spain, Valencia | |
| Hospital de Sagunto | Active, not recruiting |
| Sagunto, Valencia, Spain | |
| Principal Investigator: | Juan J Cruz, Professor | Hospital Universitario de Salamanca |
| Principal Investigator: | Ricardo Hitt, MD | Hospital Universitario 12 de Octubre |
More Information
| Responsible Party: | Grupo Español de Tratamiento de Tumores de Cabeza y Cuello ( Prof. Juan Jesús Cruz ) |
| Study ID Numbers: | TTCC-2007-01 |
| Study First Received: | July 14, 2008 |
| Last Updated: | January 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00716391 History of Changes |
| Health Authority: | Spain: Spanish Agency of Medicines |
|
Head and Neck Cancer |
|
Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Cisplatin Antineoplastic Agents |
Therapeutic Uses Head and Neck Neoplasms Physiological Effects of Drugs Cetuximab Pharmacologic Actions |