TPF Plus Cisplatin and Radiotherapy vs TPF Plus Cetuximab and Radiotherapy to Treat Head and Neck Cancer.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Grupo Español de Tratamiento de Tumores de Cabeza y Cuello.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
ClinicalTrials.gov Identifier:
NCT00716391
First received: July 14, 2008
Last updated: February 12, 2011
Last verified: February 2011
  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 3

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.

Resource links provided by NLM:


Further study details as provided by Grupo Español de Tratamiento de Tumores de Cabeza y Cuello:

Primary Outcome Measures:
  • Global survival [ Time Frame: Time between the beginning of treatment with TPF and the éxitus for any reason ] [ Designated as safety issue: Yes ]

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

Detailed Description:

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
Criteria

Inclusion Criteria:

  1. Before the beginning of protocol's specific procedures, the informed consent has to be obtained.
  2. Locally advanced cancer of head and neck (oral cavity, oropharynx, larynx and hypopharynx) stage III-IV, without evidence of metastasis.
  3. 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.

  4. Epidermoid carcinoma histologically demonstrated
  5. Measurable disease according to the RECIST criteria .
  6. Men or women with age between 18 and 70 years, both inclusive.
  7. Functional condition index according to ECOG scale:0-1
  8. Patients in medical conditions to be able to receive treatment with TPF induction followed by normofractionated radiotherapy with cetuximab or cisplatin.
  9. Patients with adequate hematologic function: neutrophils superior or equal to 2 x 109, platelets superior or equal to 100 x 109, hemoglobin superior or equal to 10 g/dl.
  10. Adequate hepatic function: bilirubin lower or equal to 1 x top normal Limit, GOT and GPT lower or equal to 2,5 Top Normal Limit , alkaline phosphatase < 5 Top Normal Limit.
  11. Adequate renal function: creatinin <1,4 mg/dl (120 µmol/l); if the values are > 1,4 mg/dl, the clearance of creatinin will have to be > 60 ml/min (real or calculated for Cockcroft-Gault's method).
  12. Calcium lower or equal to 1,25 x top normal limit.
  13. Adequate nutritional condition: loss of weight <20% with relation to the theoretical weight and albumin superior or equal to 35 g/L.
  14. Patients must be accessible for the treatment and the follow-up.

Exclusion Criteria:

  1. Metastatic disease
  2. Surgical treatment, previous radiotherapy and/or chemiotherapy for the study disease.
  3. Other tumour locations in head and neck that are not oral cavity, oropharynx, larynx, hypopharynx.
  4. Other stages that are not III or IVM0.
  5. Other previous and / or synchronic squamous carcinoma.
  6. Diagnosis of another neoplasia in the last 5 years, excepting carcinoma in situ of uterine neck and/or a cutaneous carcinoma basocellular properly treated.
  7. Active infection(at needs endovenous antibiotics), including active tuberculosis and diagnosed HIV.
  8. Not controlled hypertension defined as arterial systolic tension superior or equal to 180 mm Hg and / or diastolic arterial tension superior or equal to 130 mm Hg baseline.
  9. Pregnancy(absence must be confirmed with the test of beta-HCG) or period of lactation.
  10. Immunity systemic treatment, chronic and concomitant, or hormonal treatment of the cancer.
  11. Other antineoplastic concomitant treatments.
  12. Coronary clinically significant arteriopathy or precedents of myocardial infarction in the last 12 months or high risk of not controlled arrhythmia or cardiac not controlled insufficiency.
  13. Pulmonary obstructive chronic disease that had needed 3 or more hospitalizations in the last 12 months.
  14. Active non controlled peptic ulcer.
  15. Presence of a psychological or medical disease that could prevent to accomplish the study by the patient or to grant his/her signature in the informed consent form.
  16. Known drugs abuse (with the exception of excessive consumption of alcohol)
  17. Known allergic reaction to some of the components of the treatment of the study.
  18. Previous treatment with monoclonal antibodies or other transduction of the sign inhibitors or treatment directed against the EGFR.
  19. Any experimental treatment in 30 days before the entry in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00716391

Contacts
Contact: Juan C Adansa, MD +34 923 29 11 00 ext 749 unidad_eecc@usal.es

Locations
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         
Sponsors and Collaborators
Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
Investigators
Principal Investigator: Juan J Cruz, Professor Hospital Universitario de Salamanca
Principal Investigator: Ricardo Hitt, MD Hospital Universitario 12 de Octubre
  More Information

Additional Information:
No publications provided

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

Keywords provided by Grupo Español de Tratamiento de Tumores de Cabeza y Cuello:
Head and Neck Cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Cetuximab
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 22, 2014