patients with locally advanced squamous cell carcinoma of the head and neck MedDRA version: 9.1 Level: LLT Classification code 10060121 Term: Squamous cell carcinoma of head and neck
Conditions
Interventions
Product Name: Fluorouracil
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Fluorouracil
Product Name: Cisplatin
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cispla
Sponsors
AVAPO RICERCHE - VENEZIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically proven squamous cell carcinoma of the head and neck. 2. Primary tumor sites eligible : oral cavity, oropharynx, hypopharynx Although they are admittedly of squamous cell types, the following tumors will be excluded because of them responsiveness to chemotherapy: tumors of the nasal and paranasal cavities and of the nasopharynx.3. Stage 3 or 4 disease without evidence of distant metastases verified by chest X?Ray, abdominal ultrasound, or CT (liver function test abnormalities); bone scan in case of local symptoms.4. At least one uni or bidimensionally measurable lesion.5. Tumor considered inoperable after evaluation by a multidisciplinary team (i.e. a surgeon, a medical oncologist and a radiation oncologist). Criteria for inoperability are: a) technical unresectability: tumor fixation/invasion to base of the skull or cervical vertebrae, involvement of the nasopharynx, and fixed lymph nodes.b) Physician decision based on low surgical curability. This category will include the following: i) All T3-4 stages.ii) All N2-3 stages excluding T1 N2.iii) Patients for organ preservation. Reason for inoperability will be recorded in the CRF.6. No previous chemotherapy or radiotherapy for any reason and no previous surgery for SCCHN (other than biopsy) are allowed at time of study entry. 7. Age > 18 years.8. Karnofsky performance status > 70. (ECOG 0-1) (Appendix II)9. No active alcohol addiction.10. Life expectancy > 6 months.11. Signed informed consent prior to beginning protocol specific procedures.12. Adequate bone marrow, hepatic and renal functions as evidenced by the following:a) Hematology (Bone marrow):i) Neutrophils > 2.0 109/Lii) Platelets > 100 x 109/Liii) Hemoglobin > 10 g/dLb) Hepatic functioni) Total bilirubin 1.5 x ULN associated with alkaline phosphatase > 2.5 x ULN are not eligible for the study.c) Renal function : serum creatinine 60 ml/min (calculated by the Cockcroft-Gault method) . 13. Patients must be available for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating center. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women or women of childbearing potential not using adequate contraception.2. Previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin, or other cancer curatively treated by surgery and with no evidence of disease for at least 5 years. Any prior treatment with radiotherapy or chemotherapy is an exclusion criterion.3. Symptomatic peripheral neuropathy > grade 2 by NCIC-CTG criteria4. Symptomatic altered hearing > grade 2 by NCIC-CTG criteria.5. Other serious illnesses or medical conditions including:a) Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry.b) History of significant neurologic or psychiatric disorders including dementia or seizures.c) Active uncontrolled infection.d) Active peptic ulcer.e) Hypercalcemia.f) Chronic obstructive pulmonary disease requiring hospitalization during the year preceding study entry6. History of ipersensitivity reaction to polysorbate 80 (Appendix IV)7. Patients requiring intravenous alimentation.8. Patients who experienced a weight loss of more than 20% of their body weight in the 3 months preceding study entry.9. Concomitant treatment with any other anticancer therapy.10. Participation in a therapeutic clinical trial within 30 days of study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: · To compare the 3 years overall survival between neoadjuvant and non neoadjuvant arms · To compare the tolerability of concomitant chemoradiotherapy and radiotherapy plus Cetuximab;Secondary Objective: · To compare the radiological and pathological complete response rate at the end of treatment, the progression free survival, the duration of response, the time to progression, the hematological and non-hematological toxicity, the duration of radiotherapy plus concomitant chemo or cetuximab, the interruption number and the radiological complete response during concomitant chemoradiation and radiation plus cetuximab;Primary end point(s): 1) the 3 years the overall survival, calculated from the date of randomisation to the of death or date of last contact 2) the tolerability of concomitant chemoradiation and radiotherapy plus cetuximab | — |
Countries
Italy
Outcome results
None listed