A Phase II Study of Hyperfractionated Accelerated Radiotherapy Delivered With Integrated Neck Surgery for Node-positive Cases in Squamous Cell Carcinoma of the Head and Neck
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 169
- Locations
- 1
- Primary Endpoint
- Toxicities as per CTCAE
Study Overview
Brief Summary
This study is examining the effects of increasing the dose of radiation given to treat head and neck cancer. Radiation doses to the primary cancer are higher than usually given; lymph glands of the neck will also be treated at a lower dose. Surgery on the lymph glands my be necessary in the future. Radiation treatments given in small fractions twice a day allows a higher dose to be delivered than if the treatment was given once a day. This study will enroll patients at three sequential increasing dose levels. Approximately 40 patients will be enrolled at each dose level.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically proven squamous cell carcinoma
- •Larynx & pharynx (except Nasopharyngeal carcinoma)
- •Stage III & IV, but any stage hypopharynx
- •Informed Consent
Exclusion Criteria
- Not provided
Arms & Interventions
Hyperfractionated Accelerated Radiotherapy
Hypofractionated Accelerated Radiotherapy with integrated neck surgery
Intervention: hyperfractionated accelerated radiotherapy (Procedure)
Outcomes
Primary Outcomes
Toxicities as per CTCAE
Time Frame: 1 yr
Secondary Outcomes
No secondary outcomes reported