TPF Plus Cisplatin and Radiotherapy vs TPF Plus Cetuximab and Radiotherapy to Treat Head and Neck Cancer.
Conditions
Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms
Conditions: Keywords
Head and Neck Cancer
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: TPF, radiotherapy and cisplatin. Type: Other
Name: TPF, radiotherapy and cetuximab. Type: Other
Overall Status
Recruiting
Summary
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.
Detailed Description
This study is being sponsored by a cooperative medical group.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
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.
Locations
Hospital Puerta del Mar
Almeria, Almería, Spain
Status: Recruiting
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Status: Recruiting
Hospital Durán i Reynals
Hospitalet de Ll., Barcelona, Spain
Status: Recruiting
Hospital de Manresa
Manresa, Barcelona, Spain
Status: Recruiting
Hospital Mútua de Terrassa
Terrassa, Barcelona, Spain
Status: Recruiting
Hospital Son Dureta
Palma de Mallorca, Mallorca, Spain
Status: Recruiting
Hospital de Sagunto
Sagunto, Valencia, Spain
Status: Recruiting
Hospital general Universitario
Alicante, Spain
Status: Recruiting
Hospital Clínic i Provincial de Barcelona
Barcelona, Spain
Status: Recruiting
Hospital de Basurto
Bilbao, Spain
Status: Recruiting
Hospital General Yagüe
Burgos, Spain
Status: Recruiting
Hospital San Pedro de Alcántara
Cáceres, Spain
Status: Terminated
Hospital Dr. Trueta (ICO Girona)
Girona, Spain
Status: Recruiting
H. Virgen de las Nieves
Granada, Spain
Status: Recruiting
Oncogranada
Granada, Spain
Status: Terminated
Hospital General de Jaén
Jaén, Spain
Status: Not yet recruiting
Hospital Xeral Calde
Lugo, Spain
Status: Recruiting
Hospital Universitari Arnau de Vilanova
Lérida, Spain
Status: Recruiting
Clínica Quirón
Madrid, Spain
Status: Recruiting
Fundación Jiménez Díaz
Madrid, Spain
Status: Recruiting
Hospital Clínico San Carlos
Madrid, Spain
Status: Recruiting
Hospital Gregorio Marañon
Madrid, Spain
Status: Recruiting
Hospital La Paz
Madrid, Spain
Status: Recruiting
Hospital Universitario 12 de Octubre
Madrid, Spain
Status: Recruiting
Hospital Son Llàtzer
Mallorca, Spain
Status: Recruiting
Hospital Universitario Central de Asturias
Oviedo, Spain
Status: Recruiting
Hospital Universitario de Salamanca
Salamanca, Spain
Status: Recruiting
Hospital Universitario Marques de Valdecilla
Santander, Spain
Status: Recruiting
Hospital Clínico de Santiago
Santiago de Compostela, Spain
Status: Not yet recruiting
Hospital General de Segovia
Segovia, Spain
Status: Recruiting
Hospital Arnau de Vilanova
Valencia, Spain
Status: Recruiting
Hospital General Universitario
Valencia, Spain
Status: Recruiting
Hospital La Fe
Valencia, Spain
Status: Recruiting
Contact: Miguel Pastor Borgoñon, MD
Hospital de Meixoeiro
Vigo, Spain
Status: Recruiting
Hospital Xeral Cies
Vigo, Spain
Status: Recruiting
Hospital Provincial de Zamora
Zamora, Spain
Status: Recruiting
Hospital Clínico Lozano Blesa
Zaragoza, Spain
Status: Recruiting
Hospital Miguel Servet
Zaragoza, Spain
Status: Recruiting
Hospital Nuestra Señora de Sonsoles
Ávila, Spain
Status: Recruiting
Contact: Elena Filipovich, MD
Start Date
July 2008
Completion Date
December 2013
Sponsors
Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
Source
Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page