Head and Neck Cancer
Conditions
Keywords
HNSCC, neo Adjuvant, Chemoradiation therapy, TPF
Brief summary
The purpose of this trial is to compare two different treatments for fit patients with head and neck cancer: All patients are given induction-chemotherapy (docetaxel, cisplatin, 5-FU). Subsequently patients are being randomised into two groups: * The first group receives neo-adjuvant chemotherapy ('high' dose cisplatin) and conventional radiotherapy * The second group receives neo-adjuvant chemotherapy ('low' dose cisplatin) and accelerated radiotherapy.
Detailed description
Induction Chemotherapy TPF(arm A and B) : Docetaxel 75 mg/m2 iv on day 1, Cisplatin 75 mg/ m2 iv on day 1, 5-FU 750 mg/ m2/day iv continuous infusion (in Hickman or port a cath) on days 1-5; prophylactic G-CSF This cycle will be repeated every 21 days for a maximum of 4 cycles. Clinical evaluation after each cycle and radiological evaluation after 2 cycles will take place. In case of PD or SD (after 2 cycles) with no minor response (no decrease in measurable disease from baseline) concomitant chemoradiotherapy will started per protocol. Surgery The investigators in each centre can decide neck surgery for residual tumor
Interventions
RADIATIONconventional radiotherapy with 'high' dose cisplatin
radiotherapy: 5 fractions/week, total treatment time 7 weeks. Dose to gross tumor volume 70 Gy/35 fractions, dose to elective nodal areas 46 Gy/23 fractions. 100 mg/m2 cisplatin iv on day 1, 22 and 43
RADIATIONaccelerated radiotherapy with 'low' dose cisplatin
Accelerated radiotherapy 6 fractions/week, total treatment time 6 weeks. During one of the weekdays two fractions will be delivered with an interval of at least 6h. Dose to gross tumor volume 70 Gy/35 fractions, dose to elective nodal areas 46 Gy/23 fractions cisplatin 40 mg/m2 iv on day 1,8,18,22,29,35
Sponsors
Sanofi
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Histology and staging disease * 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 General conditions * Written informed consent * Age \>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 \< 1. 5 x upper normal limit, ASAT and ALAT \< 2.5 x upper normal limits * Adequate renal function: calculated creatinin clearance \> 60ml/min. (Cockcroft-Gault formula) Other * Expected adequacy of follow-up.
Exclusion criteria
General conditions * 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 or current history * 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 |
|---|---|
| feasibility of both study-arms | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| to assess the toxicity profile, tumour response, disease free survival and overall survival in both study-arms. Also QoL will be measured. | 2 years |
Countries
Netherlands
Contacts
Primary ContactC.M.L. van Herpen, Md, Phd
Outcome results
None listed