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. The completion date has passed and the status has not been verified in more than two years.
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
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 ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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

Locations
Spain
Hospital Puerta del Mar
Almeria, Almería, Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Hospital Durán i Reynals
Hospitalet de Ll., Barcelona, Spain
Hospital de Manresa
Manresa, Barcelona, Spain
Hospital Mútua de Terrassa
Terrassa, Barcelona, Spain
Hospital Son Dureta
Palma de Mallorca, Mallorca, Spain, 07014
Hospital de Sagunto
Sagunto, Valencia, Spain
Hospital general Universitario
Alicante, Spain
Hospital Clínic i Provincial de Barcelona
Barcelona, Spain, 08036
Hospital de Basurto
Bilbao, Spain
Hospital General Yagüe
Burgos, Spain
Hospital San Pedro de Alcántara
Cáceres, Spain
Hospital Dr. Trueta (ICO Girona)
Girona, Spain, 17007
Oncogranada
Granada, Spain, 18014
H. Virgen de las Nieves
Granada, Spain
Hospital General de Jaén
Jaén, Spain
Hospital Xeral Calde
Lugo, Spain
Hospital Universitari Arnau de Vilanova
Lérida, Spain, 25198
Hospital Clínico San Carlos
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Clínica Quirón
Madrid, Spain
Fundación Jiménez Díaz
Madrid, Spain
Hospital Gregorio Marañon
Madrid, Spain
Hospital La Paz
Madrid, Spain
Hospital Son Llàtzer
Mallorca, Spain
Hospital Universitario Central de Asturias
Oviedo, Spain, 33006
Hospital Universitario de Salamanca
Salamanca, Spain, 37007
Hospital Universitario Marques de Valdecilla
Santander, Spain, 39008
Hospital Clínico de Santiago
Santiago de Compostela, Spain
Hospital General de Segovia
Segovia, Spain
Hospital Arnau de Vilanova
Valencia, Spain, 46015
Hospital General Universitario
Valencia, Spain
Hospital La Fe
Valencia, Spain
Hospital Xeral Cies
Vigo, Spain, 36024
Hospital de Meixoeiro
Vigo, Spain, 36200
Hospital Provincial de Zamora
Zamora, Spain, 49021
Hospital Clínico Lozano Blesa
Zaragoza, Spain
Hospital Miguel Servet
Zaragoza, Spain
Hospital Nuestra Señora de Sonsoles
Ávila, 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

Additional Information:
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

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
Cisplatin
Cetuximab
Antineoplastic Agents

ClinicalTrials.gov processed this record on January 19, 2017