NRG-CC013

A Randomized, Masked, Placebo Controlled, Phase II Trial Of Concurrent Chemoradiation With BMX-001 In Patients With Head And Neck Squamous Cell Carcinoma Receiving Concurrent Chemoradiation

Co-Principal Investigator(s)

Sue S. Yom

Status

Disease Site

Head and Neck [HN] Other

Phase

II

Developmental Therapeutics

Yes

Primary Objective

To compare the incidence of severe
oral mucositis (SOM) between BMX-001 and placebo, defined as ≥ Grade 3 per WHO
criteria from the start of radiation through 4 weeks after completion of study
treatment, with additional assessments at 6, 8 and 12 weeks after completion of
study treatment.

Patient Population

• Patients
  must be planned to receive radiation and concurrent cisplatin chemotherapy as
  definitive therapy. Patients planned to receive concurrent cisplatin and
  radiation therapy in the adjuvant setting are not eligible.
• Pathologically confirmed (histologically or
  cytologically) squamous cell carcinoma of the oropharynx, larynx, hypopharynx,
  nasopharynx, or oral cavity.

Target Accrual

98