TPF Plus Cisplatin and Radiotherapy vs TPF Plus Cetuximab and Radiotherapy to Treat Head and Neck Cancer.
NCT ID: NCT00716391
Last Updated: 2019-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
519 participants
INTERVENTIONAL
2008-07-07
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
TPF plus concomitant treatment with cisplatin and conventional radiotherapy.
TPF, radiotherapy and cisplatin.
3 cycles of: cisplatin: 75 mg/m2, i.v., 1 hour, once daily docetaxel: 75 mg/m2, i.v., 1 hour, once daily 5-fluorouracil: 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
TPF plus concomitant treatment with cetuximab and conventional radiotherapy
TPF, radiotherapy and cetuximab.
3 cycles of: cisplatin: 75 mg/m2, i.v., 1 hour, once daily docetaxel: 75 mg/m2, i.v., 1 hour, once daily 5-fluorouracil: 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
Interventions
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TPF, radiotherapy and cisplatin.
3 cycles of: cisplatin: 75 mg/m2, i.v., 1 hour, once daily docetaxel: 75 mg/m2, i.v., 1 hour, once daily 5-fluorouracil: 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
TPF, radiotherapy and cetuximab.
3 cycles of: cisplatin: 75 mg/m2, i.v., 1 hour, once daily docetaxel: 75 mg/m2, i.v., 1 hour, once daily 5-fluorouracil: 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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. Surgical treatment, previous radiotherapy and/or chemotherapy for the study disease.
3. Other tumor 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.
18 Years
70 Years
ALL
No
Sponsors
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Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
OTHER
Responsible Party
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Principal Investigators
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Juan J Cruz, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Salamanca
Ricardo Hitt, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario 12 de Octubre
Locations
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Hospital Puerta del Mar
Almería, Almería, Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
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
Hospital Son Llàtzer
Palma de Mallorca, Mallorca, Spain
Hospital de Sagunto
Sagunto, Valencia, Spain
Hospital general Universitario
Alicante, , Spain
Hospital Nuestra Señora de Sonsoles
Ávila, , Spain
Hospital Clínic i Provincial de Barcelona
Barcelona, , Spain
Hospital de Basurto
Bilbao, , Spain
Hospital General Yagüe
Burgos, , Spain
Hospital San Pedro de Alcántara
Cáceres, , Spain
Hospital Dr. Trueta (ICO Girona)
Girona, , Spain
Oncogranada
Granada, , Spain
H. Virgen de las Nieves
Granada, , Spain
Hospital General de Jaén
Jaén, , Spain
Hospital Universitari Arnau de Vilanova
Lleida, , Spain
Hospital Xeral Calde
Lugo, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Clínica Quirón
Madrid, , Spain
Fundación Jiménez Díaz
Madrid, , Spain
Hospital Gregorio Marañon
Madrid, , Spain
Hospital La Paz
Madrid, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Marques de Valdecilla
Santander, , Spain
Hospital Clínico de Santiago
Santiago de Compostela, , Spain
Hospital General de Segovia
Segovia, , Spain
Hospital Arnau de Vilanova
Valencia, , Spain
Hospital General Universitario
Valencia, , Spain
Hospital La Fe
Valencia, , Spain
Hospital Xeral Cies
Vigo, , Spain
Hospital de Meixoeiro
Vigo, , Spain
Hospital Provincial de Zamora
Zamora, , Spain
Hospital Clínico Lozano Blesa
Zaragoza, , Spain
Hospital Miguel Servet
Zaragoza, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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This site would like to expose the activities of the group and at the same time serve as an information and communication tool of this pathology for professionals and patients.
Other Identifiers
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TTCC-2007-01
Identifier Type: -
Identifier Source: org_study_id
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