Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DOCETAXEL XRP6976 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Docetaxel, Cisplatin | EXPERIMENTAL | Induction:One-hour intravenous infusion of docetaxel at 75 mg/m2 followed by a 30 minute intravenous infusion of cisplatin at 75 mg/m2. All patients to be pre-medicated with oral dexamethasone at 8 mg twice daily for 3 days, commencing one day before docetaxel infusion. All patients will be premedicated with intravenous dexamethasone 20 mg to be administered before cisplatin infusion. Docetaxel and cisplatin treatments to be repeated every 21 days for three cycles. Chemoradiotherapy (CRT): Cisplatin to be administered by 30 minutes intravenous infusion at a dose of 30 mg/m2 weekly starting concomitantly with conventional radiotherapy for a period of 6 weeks. Intravenous cisplatin to be continued for four weeks. Radiotherapy: Gross disease dose will be 60 Gy/30 fractions and sub clinical dose 45-50 Gy/30 fractions. |
| Name | Type | Description |
|---|---|---|
| Cisplatin | DRUG | Pharmaceutical form:solution Route of administration: intravenous |
| DOCETAXEL XRP6976 | DRUG | Pharmaceutical form:solution Route of administration: intravenous |
| Dexamethasone | DRUG | Pharmaceutical form:tablet Route of administration: oral |
Inclusion criteria : * Histologically confirmed, unresectable locally advanced squamous cell carcinoma of head and neck of oral cavity in stage III-IV without evidence of distant metastases. * No prior chemotherapy or radiation therapy. * Having at least one measurable lesion in one dimension. * Ag...