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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
SINGLE
Enrollment
73
Bharat Cancer Hospital & Research Institute
Surat, Gujarat, India
Sri Venkateshwara Hospitals
Bangalore, Karnataka, India
Mazumdar Shaw Cancer Center
Bangalore, Karnataka, India
Tata Memorial Hospital
Mumbai, Maharashtra, India
Number of severe Radiation Induced Mucositis (WHO grade >=3)
For Phase2, to assess the incidence of severe (WHO Grade \>=3) Radiation Induced Mucositis (RIM)occurring up to a cumulative radiation dose of 66 Gray (Gy) based on the WHO mucositis scale in subjects with locally advanced squamous cell carcinoma of the head and neck (SCCHN) treated with cisplatin and radiotherapy plus P276-00 * For Phase 3 * To assess and compare the incidence of severe (WHO Grade\>=3) Radiation Induced Mucositis (RIM) occurring up to a cumulative radiation dose of 54 Gy based on the WHO mucositis scale * To assess and compare the incidence of severe (WHO Grade\>=3) RIM occurring up to a cumulative radiation dose of 66 Gy based on the WHO mucositis scale in subjects with locally advanced SCCHN treated with cisplatin and radiotherapy plus P276-00 or cisplatin and radiotherapy (the two treatment arms).
Time frame: Week 15
Time to onset of severe RIM (WHO Grade ≥ 3)
To evaluate the time to onset of severe RIM (WHO Grade\>=3) as defined by the number of days between start of study treatment and the first time that WHO Grade 3 or 4 mucositis was observed (regardless of whether it had been Grade 0,1 or 2 previously)
Time frame: Week 15
Duration of severe RIM (WHO Grade>=3)
To assess the duration of severe RIM (WHO Grade\>=3) as defined by the number of days from the onset of severe RIM as defined above, to the day when severe RIM resolved (first time when WHO Grade 0, 1, or 2 was observed)
Time frame: Week 15
Progression-Free Survival (PFS)
To assess Progression-Free Survival (PFS)
Time frame: 1year
Overall Survival (OS)
To assess Overall Survival (OS)
Time frame: 1year
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Curie Manavta Cancer Centre
Nashik, Maharashtra, India
Ruby Hall Clinic
Pune, Maharashtra, India
Meenakshi Mission Hosp. & Res. Centre
Madurai, Tamil Nadu, India