Clinical trial NCT00716391: TPF Plus Cisplatin and Radiotherapy vs TPF Plus Cetuximab and Radiotherapy to Treat Head and Neck Cancer.
Official title: Open Label Randomized, Multi-centre Phase III Trial of TPF Plus Concomitant Treatment With Cisplatin and Radiotherapy Versus Concomitant Cetuximab and Radiotherapy in Locally Advanced, Unresectable Head and Neck Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Head and Neck Cancer
Keywords: Head and Neck Cancer
Lead sponsor: Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
Sponsor class: OTHER
First posted: 2008-07-16
Enrollment: 519
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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 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.

Primary outcomes:
measure: Global survival
timeFrame: Up to 89 months
Secondary outcomes:
measure: Overall response rate (ORR)
timeFrame: Up to 89 months
measure: Progression free-survival (PFS)
timeFrame: Up to 89 months
measure: Time to loco-regional control of disease
timeFrame: Up to 89 months
measure: Satisfaction with treatment. Analysis of QoL in both treatment arms.
timeFrame: Up to 89 months
Other outcomes:
Locations:
city: Almeria
country: Spain
facility: Hospital Puerta del Mar
state: Almería
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Hospitalet de Ll.
country: Spain
facility: Hospital Durán i Reynals
state: Barcelona
city: Manresa
country: Spain
facility: Hospital de Manresa
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Mútua de Terrassa
state: Barcelona
city: Palma de Mallorca
country: Spain
facility: Hospital Son Dureta
state: Mallorca
city: Palma De Mallorca
country: Spain
facility: Hospital Son Llàtzer
state: Mallorca
city: Sagunto
country: Spain
facility: Hospital de Sagunto
state: Valencia
city: Alicante
country: Spain
facility: Hospital general Universitario
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial de Barcelona
city: Bilbao
country: Spain
facility: Hospital de Basurto
city: Burgos
country: Spain
facility: Hospital General Yagüe
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcántara
city: Girona
country: Spain
facility: Hospital Dr. Trueta (ICO Girona)
city: Granada
country: Spain
facility: Oncogranada
city: Granada
country: Spain
facility: H. Virgen de las Nieves
city: Jaén
country: Spain
facility: Hospital General de Jaén
city: Lugo
country: Spain
facility: Hospital Xeral Calde
city: Lérida
country: Spain
facility: Hospital Universitari Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Clínica Quirón
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital La Paz
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico de Santiago
city: Segovia
country: Spain
facility: Hospital General de Segovia
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
city: Valencia
country: Spain
facility: Hospital General Universitario
city: Valencia
country: Spain
facility: Hospital La Fe
city: Vigo
country: Spain
facility: Hospital Xeral Cies
city: Vigo
country: Spain
facility: Hospital de Meixoeiro
city: Zamora
country: Spain
facility: Hospital Provincial de Zamora
city: Zaragoza
country: Spain
facility: Hospital Clínico Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
city: Ávila
country: Spain
facility: Hospital Nuestra Señora de Sonsoles
Study officials:
affiliation: University of Salamanca
name: Juan J Cruz, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario 12 de Octubre
name: Ricardo Hitt, MD
role: PRINCIPAL_INVESTIGATOR
References: