locally advanced HNSCC
Conditions
Interventions
Product Name: docetaxel
Pharmaceutical Form: Concentrate for solution for infusion
Product Name: cisplatin
Pharmaceutical Form: Concentrate for solution for infusion
Product Name: 5-fluorouracil (5-
Sponsors
University Medical Centre Nijmegen St Radboud
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Histologically or cytologically proven non-metastatic locally advanced HNSCC, stage III or IV, for which concomitant chemo-radiotherapy would be the standard therapy -Patients can be included either with irresectable disease or for which the concomitant chemoradiotherapy was chosen for organ preservation -Measurable disease -Primary site: oral cavity, oropharynx, hypopharynx and larynx -Written informed consent -Age between 18 years and 65 years -WHO performance status 0-1 -Adequate bone marrow function (WBC > 3.0 x 109/L, platelets > 100 x 109/L, Hb > 6 mmol/L) -Adequate hepatic function: total bilirubin 60ml/min. (Cockcroft-Gault formula) -Expected adequacy of 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: -Active alcohol addiction -Admission for COPD in the last 12 months -Weight loss > 10% in 3 months before entry -Pregnancy or lactation -Patients (M/F) with reproductive potential not implementing adequate contraceptives measures -Prior surgery, radiotherapy or chemotherapy for this tumor -Serious concomitant diseases preventing the safe administration of chemotherapy and/or radiotherapy or likely to interfere with the study assessments -Serious active infections -Other malignancies in the past 5 years with the exception of adequately treated carcinoma in situ of the cervix, or squamous or basal cell carcinoma of the skin Concomitant treatments -Concomitant (or within 4 weeks before randomisation) administration of any other experimental drug under investigation -Concurrent treatment with any other anti-cancer therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the feasibility of induction TPF followed by CRT with conventional RT versus induction TPF followed by CRT with accelerated RT for locally advanced HNSCC;Secondary Objective: Toxicity profile (acute and late adverse events) Quality of life (QoL) Tumour response (CR, PR or SD) Disease free survival Overall survival ;Primary end point(s): To assess the feasibility of induction TPF followed by CRT with conventional RT versus induction TPF followed by CRT with accelerated RT for locally advanced HNSCC | — |
Countries
Netherlands
Outcome results
None listed