Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00995293 | Taxotere (Docetaxel) New Indication: Squamous Cell Carcinoma of the Head and Neck (SCCHN) Treatment Registration Trial | PHASE3 | COMPLETED | 240 | — | — | Aug 27, 2009 | Jan 26, 2018 | Mar 2, 2018 | 1 | China |
| NCT00401323 | Taxotere (Docetaxel) in 1st Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma | PHASE2 | COMPLETED | 568 | — | — | Jan 1, 1998 | Jun 1, 2003 | Jan 20, 2011 | 20 | United States, Argentina +18 |
| Arm | Type | Description |
|---|---|---|
| Docetaxel Cisplatin 5-Fluorouracil (DCF) | EXPERIMENTAL | 4 cycles of the following products every 3 weeks (unless disease progression/relapse or unacceptable toxicity occured or the patient refused treatment): * Docetaxel 60mg/m² on day 1 * Cisplatin 75mg/m² on day 1 * 5-FU 750mg/m²/day on day 1 to day 5 |
| Cisplatin 5-Fluorouracil (CF) | EXPERIMENTAL | 4 cycles of the following products every 3 weeks (unless disease progression/relapse or unacceptable toxicity occured or the patient refused treatment): * Cisplatin 75mg/m² on day 1 * 5-FU 750mg/m²/day on day 1 to day 5 |
| docetaxel plus cisplatin | EXPERIMENTAL | Taxotere 75 mg/m², one-hour IV infusion on Day 1 of each 3-week cycle followed by cisplatin 75 mg/m² administered as a 30-minute to 3-hour infusion on Day 1 |
| cisplatin plus 5-FU | ACTIVE_COMPARATOR | Cisplatin 100 mg/m², 30-minute to 3-hour infusion on Day 1 of each 3-week cycle followed by the continuous infusion of 5-FU 1000 mg/m²/day from Day 1 to Day 5 |
| docetaxel plus 5-FU | EXPERIMENTAL | Taxotere 85 mg/m², one-hour IV infusion on Day 1 of each 3-week cycle followed by the continuous infusion of 5-FU 750 mg/m²/day from Day 1 to Day 5 Arm only in the phase II part of the study |
| Name | Type | Description |
|---|---|---|
| DOCETAXEL | DRUG | Intravenous |
| CISPLATIN | DRUG | Intravenous |
| 5-FLUOROURACIL | DRUG | Intravenous |
| docetaxel (XRP6976) | DRUG | - |
| 5-fluorouracil (5-FU) | DRUG | - |
Inclusion criteria: * Tumor type: Histologically or cytologically proven squamous cell carcinoma of the head and neck (SCCHN) presenting with locally advanced disease at diagnosis. Primary tumor sites eligible are: oral cavity, oropharynx, hypopharynx and larynx. * Extent of the disease: * Patie...