TPF Plus Cisplatin and Radiotherapy vs TPF Plus Cetuximab and Radiotherapy to Treat Head and Neck Cancer.

NCT00716391 | Completed Phase 3

• 1 other identifier: TTCC-2007-01
• Study Type: interventional
• Target: 519
• Locations: 1 country
• Sites: 39

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.

Conditions

Head and Neck Cancer

Keywords

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Global survival

  The time from the start of induction chemotherapy with TPF to death due to any cause or to the last check-up in the case of living patients

  Up to 89 months

Secondary Outcomes (4)

• Overall response rate (ORR)

  Up to 89 months

• Progression free-survival (PFS)

  Up to 89 months

• Time to loco-regional control of disease

  Up to 89 months

• Satisfaction with treatment. Analysis of QoL in both treatment arms.

  Up to 89 months

Study Arms (2)

Group A

ACTIVE COMPARATOR

TPF plus concomitant treatment with cisplatin and conventional radiotherapy.

Other: TPF, radiotherapy and cisplatin.

Group B

EXPERIMENTAL

TPF plus concomitant treatment with cetuximab and conventional radiotherapy

Other: TPF, radiotherapy and cetuximab.

Interventions

TPF, radiotherapy and cisplatin. OTHER

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

Also known as: TPF plus radiotherapy and cisplatin

Group A

TPF, radiotherapy and cetuximab. OTHER

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

Also known as: TPF plus radiotherapy and cetuximab

Group B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Before the beginning of protocol's specific procedures, the informed consent has to be obtained.
• Locally advanced cancer of head and neck (oral cavity, oropharynx, larynx and hypopharynx) stage III-IV, without evidence of metastasis.
• 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:
• Technically not resectable (includes: evidence of mediastinal dissemination; fixed tumor to the clavicle, base of the cranium or cervical vertebrae; affectation of the nasopharynx).
• Medical criteria based on a low surgical curability. 3.3.Medical contraindication for the surgery.
• Epidermoid carcinoma histologically demonstrated
• Measurable disease according to the RECIST criteria .
• Men or women with age between 18 and 70 years, both inclusive.
• Functional condition index according to ECOG scale:0-1
• Patients in medical conditions to be able to receive treatment with TPF induction followed by normofractionated radiotherapy with cetuximab or cisplatin.
• 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.
• 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.
• 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).
• Calcium lower or equal to 1,25 x top normal limit.

You may not qualify if:

• Metastatic disease
• Surgical treatment, previous radiotherapy and/or chemotherapy for the study disease.
• Other tumor locations in head and neck that are not oral cavity, oropharynx, larynx, hypopharynx.
• Other stages that are not III or IVM0.
• Other previous and / or synchronic squamous carcinoma.
• Diagnosis of another neoplasia in the last 5 years, excepting carcinoma in situ of uterine neck and/or a cutaneous carcinoma basocellular properly treated.
• Active infection(at needs endovenous antibiotics), including active tuberculosis and diagnosed HIV.
• 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.
• Pregnancy(absence must be confirmed with the test of beta-HCG) or period of lactation.
• Immunity systemic treatment, chronic and concomitant, or hormonal treatment of the cancer.
• Other antineoplastic concomitant treatments.
• 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.
• Pulmonary obstructive chronic disease that had needed 3 or more hospitalizations in the last 12 months.
• Active non controlled peptic ulcer.
• 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.

Sponsors & Collaborators

• Grupo Español de Tratamiento de Tumores de Cabeza y Cuello: lead

Study Sites (39)

Hospital Puerta del Mar

Almería, Almería, Spain

Location

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Durán i Reynals

Hospitalet de Ll., Barcelona, Spain

Location

Hospital de Manresa

Manresa, Barcelona, Spain

Location

Hospital Mútua de Terrassa

Terrassa, Barcelona, Spain

Location

Hospital Son Dureta

Palma de Mallorca, Mallorca, 07014, Spain

Location

Hospital Son Llàtzer

Palma de Mallorca, Mallorca, 07198, Spain

Location

Hospital de Sagunto

Sagunto, Valencia, Spain

Location

Hospital general Universitario

Alicante, Spain

Location

Hospital Nuestra Señora de Sonsoles

Ávila, Spain

Location

Hospital Clínic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

Hospital de Basurto

Bilbao, Spain

Location

Hospital General Yagüe

Burgos, Spain

Location

Hospital San Pedro de Alcántara

Cáceres, Spain

Location

Hospital Dr. Trueta (ICO Girona)

Girona, 17007, Spain

Location

Oncogranada

Granada, 18014, Spain

Location

H. Virgen de las Nieves

Granada, Spain

Location

Hospital General de Jaén

Jaén, Spain

Location

Hospital Universitari Arnau de Vilanova

Lleida, 25198, Spain

Location

Hospital Xeral Calde

Lugo, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Clínica Quirón

Madrid, Spain

Location

Fundación Jiménez Díaz

Madrid, Spain

Location

Hospital Gregorio Marañon

Madrid, Spain

Location

Hospital La Paz

Madrid, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, 33006, Spain

Location

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, 39008, Spain

Location

Hospital Clínico de Santiago

Santiago de Compostela, Spain

Location

Hospital General de Segovia

Segovia, Spain

Location

Hospital Arnau de Vilanova

Valencia, 46015, Spain

Location

Hospital General Universitario

Valencia, Spain

Location

Hospital La Fe

Valencia, Spain

Location

Hospital Xeral Cies

Vigo, 36024, Spain

Location

Hospital de Meixoeiro

Vigo, 36200, Spain

Location

Hospital Provincial de Zamora

Zamora, 49021, Spain

Location

Hospital Clínico Lozano Blesa

Zaragoza, Spain

Location

Hospital Miguel Servet

Zaragoza, Spain

Location

Related Links

• 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.

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Radiotherapy; Cisplatin; Cetuximab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Juan J Cruz, Professor

  University of Salamanca

  PRINCIPAL INVESTIGATOR

• Ricardo Hitt, MD

  Hospital Universitario 12 de Octubre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2008
• First Posted: July 16, 2008
• Study Start: July 7, 2008
• Primary Completion: July 18, 2017
• Study Completion: December 1, 2017
• Last Updated: May 24, 2019

Record last verified: 2019-05

Locations

ES (39)