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 because the information has not been verified recently.
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

July 14, 2008
February 12, 2011
July 2008
July 2013   (final data collection date for primary outcome measure)
Global survival [ Time Frame: Time between the beginning of treatment with TPF and the éxitus for any reason ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00716391 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
TPF Plus Cisplatin and Radiotherapy vs TPF Plus Cetuximab and Radiotherapy to Treat Head and Neck Cancer.
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.

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.

This study is being sponsored by a cooperative medical group.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Head and Neck Cancer
  • 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
  • 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
  • Active Comparator: Group A
    TPF plus concomitant treatment with cisplatin and conventional radiotherapy.
    Intervention: Other: TPF, radiotherapy and cisplatin.
  • Experimental: Group B
    TPF plus concomitant treatment with cetuximab and conventional radiotherapy
    Intervention: Other: TPF, radiotherapy and cetuximab.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
458
December 2013
July 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact: Juan C Adansa, MD +34 923 29 11 00 ext 749 unidad_eecc@usal.es
Spain
 
NCT00716391
TTCC-2007-01
No
Prof. Juan Jesús Cruz, Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
Not Provided
Principal Investigator: Juan J Cruz, Professor Hospital Universitario de Salamanca
Principal Investigator: Ricardo Hitt, MD Hospital Universitario 12 de Octubre
Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP