ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
TPF Plus Cisplatin and Radiotherapy vs TPF Plus Cetuximab and Radiotherapy to Treat Head and Neck Cancer.

This study is not yet open for participant recruitment.
Verified by Grupo Español de Tratamiento de Tumores de Cabeza y Cuello, July 2008

Sponsored by: 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

MedlinePlus related topics:   Cancer    Head and Neck Cancer   

ChemIDplus related topics:   Docetaxel    Cisplatin    Cetuximab   

U.S. FDA Resources

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.

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     Not yet recruiting
      Barcelona, Spain, 08036
      Principal Investigator: Juan J Grau, MD            
Hospital Dr. Trueta (ICO Girona)     Not yet recruiting
      Girona, Spain, 17007
      Principal Investigator: José Rubio, MD            
Oncogranada     Not yet recruiting
      Granada, Spain, 18014
      Principal Investigator: Joaquín Belón, MD            
Hospital Universitario 12 de Octubre     Not yet 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            
Hospital Universitario de Salamanca     Active, not recruiting
      Salamanca, Spain, 37007
Hospital de Meixoeiro     Not yet recruiting
      Vigo, Spain, 36200
      Principal Investigator: Carlos Grande, MD            
Hospital Xeral Cies     Not yet recruiting
      Vigo, Spain, 36024
      Principal Investigator: Javier Castellanos, MD            
Hospital Provincial de Zamora     Not yet recruiting
      Zamora, Spain, 49021
      Principal Investigator: Yolanda López, MD            
Spain, Barcelona
Hospital Germans Trias i Pujol     Active, not recruiting
      Badalona, Barcelona, Spain, 08916
Spain, Mallorca
Hospital Son Dureta     Not yet recruiting
      Palma de Mallorca, Mallorca, Spain, 07014
      Principal Investigator: José Fuster, 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

Responsible Party:   Grupo Español de Tratamiento de Tumores de Cabeza y Cuello ( Prof. Juan Jesús Cruz )
Study ID Numbers:   TTCC-2007-01
First Received:   July 14, 2008
Last Updated:   July 14, 2008
ClinicalTrials.gov Identifier:   NCT00716391
Health Authority:   Spain: Spanish Agency of Medicines

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

Study placed in the following topic categories:
Docetaxel
Cisplatin
Head and Neck Neoplasms
Cetuximab

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

ClinicalTrials.gov processed this record on September 05, 2008




Links to all studies - primarily for crawlers