locally advanced squamous cell carcinoma of the head and neck MedDRA version: 12.0 Level: LLT Classification code 10063569 Term: Metastatic squamous cell carcinoma
Conditions
Interventions
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Cisplatin
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number: 75-
Pharm
Sponsors
G.O.N.O. - GRUPPO ONCOLOGICO NORD OVEST
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1.Signed written informed consents prior to beginning protocol. 2. ? 18 years of age. 3. Histologically or cytologically confirmed diagnosis of HNSCC of oral cavity, oropharynx, hypopharynx or larynx. 4. Tumor tissue available for immunohistochemical staining of HPV and EGFR expression. (clinical protocol: 11. APPENDIX 3). 5. Stage III/IVa/IVb (UICC 2002 6th edition). Patients with tumor of hypopharynx and base of tongue stage II are eligible. 6. Not suitable for surgery disease at ENT evaluation. 7. Technically resectable disease needing demolitive surgery and with definitive cure rate improbable or medical contraindication for surgery. 8. Patient?s surgery refusal. 9. ECOG Performance Status 0-2 at study entry. 10. Neutrophils ? 1,5 x 109/L , platelet count ? 120 x 109/L and hemoglobin ? 10 g/dl Normal liver function, as follows: Total bilirubin ≤ 1,5 x ULN, Creatinine clearance ? 60 ml/min (Cockroft-Gault method). 11. Odontologic intervention completed from two weeks. 12. Nutritional evaluation. 13. Phisycal examination (clinical protocol: VALUTAZIONE BASALE 5.2.) 14. Effective contraception if risk of conception exists. 15. Psychological, familiar, social and geographic conditions that can guarantee the adhesion to the protocol and the follow-up. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Distant metastasis. 2. Nasopharyngeal carcinoma WHO type II or III. 3. Prior surgery, excluding prior diagnostic biopsy. 4. Prior systemic chemotherapy and/or radiotherapy; Concurrent chronic systemic immune therapy, chemotherapy for disease other than cancer, or hormone therapy not indicated in the study protocol. 5. Medical or psychological condition that would not permit the patient to complete the trial or sign informed consent. Other concomitant anticancer therapy. 6. Known chronic heart failure. Clinically relevant coronary artery disease or history of a myocardial infarction within the last 12 months before study entry. 7. Active uncontrolled infection. 8. Known peripheral neuropathy ? grade 2 NCI-CTC version 3.0. 9. Previous or current malignancy except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix. 10. Pregnancy (absence confirmed by b-HCG test) or lactation period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: overall survival;Secondary Objective: - Time to survival free of progression - safety - % of objective response - locoregional control of disease;Primary end point(s): overall survival | — |
Countries
Italy
Outcome results
None listed