At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed squamous cell carcinoma of oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx
- ✓Newly diagnosed, locally advanced, unresectable/unresected AJCC Stage III, IVA, or IVB disease
- ✓At least 50 Gy radiation to oral cavity/oropharynx mucosa that is visualizable
- ✓Concurrent cisplatin chemotherapy at 100 mg/m² on days 1, 22, and 43
- ✕History of other primary malignancy, except curatively treated in situ cervical cancer or basal cell carcinoma of skin without evidence of disease for >3 years
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Weekly Doses of Palifermin (rHuKGF) for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer Receiving Radiotherapy With Concurrent Chemotherapy (RT/CT)
In Brief
A Phase 3 clinical trial evaluating Placebo, palifermin, and 2 other interventions for Mucositis and 4 related conditions. Completed, enrolled 188 participants.
Detailed Summary
The purpose of this research study is to test the safety and effectiveness of palifermin to determine if weekly doses can be safely administered to reduce the incidence (occurrence of), duration (length of time) and severity (amount of pain) of oral mucositis (painful sores in the mouth). Mucositis is a common side effect for patients receiving chemotherapy (cancer-killing drug) and radiotherapy (cancer-killing x-rays) for the treatment of head and neck cancer (HNC).
Study Details
Timeline
Interventions
Commercially available cisplatin was administered as an intravenous infusion at a dose of 100 mg/m\^2 on Days 1, 22, and 43.
Radiotherapy was delivered in 200 cGy daily fractions, 5 days a week.