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TPF Plus Cisplatin and Radiotherapy vs TPF Plus Cetuximab and Radiotherapy to Treat Head and Neck Cancer.
This study is currently recruiting participants.
Verified by Grupo Español de Tratamiento de Tumores de Cabeza y Cuello, January 2009
First Received: July 14, 2008   Last Updated: January 5, 2009   History of Changes
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.

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
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

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
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 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
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

No publications provided

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

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

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

ClinicalTrials.gov processed this record on November 30, 2009