Radiation Induced Mucositis in Head and Neck Cancer Clinical Trial
Official title:
A Multicenter, Phase II/III Study to Assess Radiation Induced Mucositis in Subjects With Locally Advanced Squamous Cell Carcinoma of the Head and Neck Administered Cisplatin and Radiation With or Without P276-00
A Clinical Study to Assess Radiation Induced Mucositis in Subjects with Locally Advanced Squamous Cell Carcinoma of the Head and Neck
A Multicenter, Phase II/III Study to Assess Radiation Induced Mucositis in Subjects with
Locally Advanced Squamous Cell Carcinoma of the Head and Neck Administered Cisplatin and
Radiation with or without P276-00
The Phase II component will be a single arm, open label, multicenter study to assess RIM in
subjects with locally advanced SCCHN treated with P276-00 in combination with radiation
therapy and cisplatin. `
The Phase III component will be a randomized, assessor blinded, multicenter, two-arm study
to compare the time to onset of WHO Grade ≥ 3 RIM in subjects with locally advanced SCCHN
(OC, OP, HP, and L) who are receiving definitive CRT for treatment of their malignancy.
Subjects receiving definitive CRT will receive weekly intravenous cisplatin administered
during radiation.
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Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment