Hypofractionated Accelerated Pelvic Nodal Radiotherapy (GCC 2048)
NCT04486755 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2026-05-11
Summary
A phase I trial to determine the safety of delivering three sequentially shorter RT schedules (20, 16, and 12 fractions) of HypoFx pelvic nodal RT in combination with a HypoFx, simultaneous integrated boost (SIB) to the prostate that have been designed to incrementally increased the biological equivalent dose (BED) to prostate cancer, while maintaining a constant BED to normal tissue toxicity.
Conditions
- Prostate Cancer
- Prostate Adenocarcinoma
Interventions
- RADIATION
-
Hypofractionated Radiation Therapy
All patients RT will be delivered utilizing pencil beam scanning proton therapy. Radiation treatment will be delivered 4 days per week.
Sponsors & Collaborators
-
University of Maryland, Baltimore
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-11-19
- Primary Completion
- 2026-08-31
- Completion
- 2027-08-31
Countries
- United States
Study Locations
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