Status:
COMPLETED
TPF Plus Cisplatin and Radiotherapy vs TPF Plus Cetuximab and Radiotherapy to Treat Head and Neck Cancer.
Lead Sponsor:
Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 an...
Detailed Description
This study is being sponsored by a cooperative medical group.
Eligibility Criteria
Inclusion
- 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:
- 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).
- 2.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.
- Adequate nutritional condition: loss of weight \<20% with relation to the theoretical weight and albumin superior or equal to 35 g/L.
- Patients must be accessible for the treatment and the follow-up.
Exclusion
- 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.
- Known drugs abuse (with the exception of excessive consumption of alcohol)
- Known allergic reaction to some of the components of the treatment of the study.
- Previous treatment with monoclonal antibodies or other transduction of the sign inhibitors or treatment directed against the EGFR.
- Any experimental treatment in 30 days before the entry in the study.
Key Trial Info
Start Date :
July 7 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
519 Patients enrolled
Trial Details
Trial ID
NCT00716391
Start Date
July 7 2008
End Date
December 1 2017
Last Update
May 24 2019
Active Locations (39)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Puerta del Mar
Almería, Almería, Spain
2
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
3
Hospital Durán i Reynals
Hospitalet de Ll., Barcelona, Spain
4
Hospital de Manresa
Manresa, Barcelona, Spain