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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00095927 | Randomized Amifostine For SCCHN | PHASE2 | COMPLETED | 58 | — | — | May 1, 2003 | Jun 1, 2008 | Jan 4, 2017 | 9 | United States |
| Arm | Type | Description |
|---|---|---|
| Arm A Amifostine | ACTIVE_COMPARATOR | Patients with newly diagnosed, locally advanced stage ill or IV SCCHN received; * 4 weekly doses of carboplatin (area under the curve, 1.5) and paclitaxel (45 mg/m 2) concurrently with concomitant boost radiation consisting of 72 grays in 42 fractions over 6 weeks (every day for 18 days, twice a day for 12 days) (grading determined according to the TNM staging system). * Subcutaneous daily amifostine at a dose of 500 mg |
| Arm B No-Amifostine | EXPERIMENTAL | Patients with newly diagnosed, locally advanced stage ill or IV SCCHN \- 4 weekly doses of carboplatin (area under the curve, 1.5) and paclitaxel (45 mg/m 2) concurrently with concomitant boost radiation consisting of 72 grays in 42 fractions over 6 weeks (every day for 18 days, twice a day for 12 days) (grading determined according to the TNM staging system). |
| Name | Type | Description |
|---|---|---|
| Amifostine | DRUG | Given subcutaneously |
| Carboplatin | DRUG | Given IV |
| Paclitaxel | DRUG | Given IV |
| radiation | RADIATION | Given once daily for 4 weeks and then twice daily for 2 weeks. |
Inclusion Criteria * Histologically or cytologically proven squamous cell carcinoma of the head and neck. Biopsy is preferred unless medically contraindicated. * Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx or larynx. Tumors of the nasal and paranasal cavities will also be inc...