This is a randomized, multicenter, phase III trial comparing induction chemotherapy with Docetaxel, Cisplatin and 5-Fluorouracil (TPF) followed by concurrent chemoradiotherapy to concurrent chemoradiotherapy alone, in nasopharyngeal cancers staged as T2b, T3, T4 and/or with lymph node involvement (≥ N1. The main end point is the event free survival.
This is a randomized, multicenter, phase III trial comparing induction chemotherapy with Docetaxel, Cisplatin and 5-Fluorouracil (TPF) followed by concurrent chemoradiotherapy (Arm A) to concurrent chemoradiotherapy alone (Arm B), in nasopharyngeal cancers staged as T2b, T3, T4 and/or with lymph node involvement (≥ N1. The main end point is the event free survival. The treatments are : Arm A: induction chemotherapy: Docetaxel (75 mg/m² administered on D1 of each course, every 3 weeks via one-hour IV infusion) + Cisplatin(75 mg/m² administered on D1 via one-hour infusion )+ 5-FU (750 mg/m²/d administered as a continuous infusion from D1 to D5. The cycles will be repeated every 3 weeks up to a total of 3 courses. followed by chemoradiotherapy with Cisplatin (40 mg/m2 starting on D1 of the radiation therapy) during 7 weeks Arm B: Chemoradiotherapy with Cisplatin alone (40 mg/m2 starting on D1 of the radiation therapy) during 7 weeks
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
83
Induction chemotherapy (Docetaxel, Cisplatin and 5-Fluorouracil) + concurrent radiochemotherapy
Hôpital de la Pitié-Salpétrière
Paris, France
Institut Gustave Roussy
Villejuif, France
University of Casablanca
Casablanca, Morocco
University of Cluj
Cluj-Napoca, Romania
Hôpital Habib Bourguiba
Event free-survival
Time frame: 3 years
Survival
Time frame: 3 years
late and acute toxicity according to NCI-CTC and EORTC/RTOG criteria
Time frame: early and late
Cumulative incidence of loco-regional progression
Time frame: 3 years
Cumulative rate of metastasis
Time frame: 3 years
Global response to chemo-radiotherapy
Time frame: 3 years
Global response to induction chemotherapy
Time frame: after the induction chemotherapy of the last patient included
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Sfax, Tunisia