UPRIGHT-PRO: Prospective Development Study of Upright Proton Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Stanford University
- Enrollment
- 450
- Locations
- 2
- Primary Endpoint
- Feasibility of upright proton therapy
Study Overview
Brief Summary
This study is being done to evaluate whether cancer patients can safely and reliably receive proton radiation therapy while positioned upright. Proton therapy is an established form of radiation treatment, and the upright treatment system used in this study has been cleared by the U.S. Food and Drug Administration. The intent of this protocol is to observe the treatment methods, doses, and outcomes for the initial cohorts of patients treated with this upright device. This study will support research activities and evaluate feasibility as needed. Results of this study will be reported in the scientific literature but the investigators do not intend to report to the FDA for a new use or indication or change to the labeling; nor are the investigators required to do so.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Any cancer patient (children and adults) recommended for proton therapy.
- •Participation in other clinical trials is allowed (including randomized trials of protons versus other treatments)
Exclusion Criteria
- •Any patient that doesn't meet the inclusion criteria
Outcomes
Primary Outcomes
Feasibility of upright proton therapy
Time Frame: End of proton therapy (3 months)
Feasibility is defined by the proportion of evaluable patients who complete a technically successful course of upright proton therapy. Technically successful course of upright proton therapy is defined as ≥80% of prescribed proton fractions delivered with upright proton therapy. Feasible if ≥70% of evaluable cases meet technically successful criterion.
Secondary Outcomes
- Quality of Life (FACT-G)(Baseline and end of proton therapy (3 months))
- Treatment Satisfaction (FACIT-TS-G)(End of proton therapy (3 months))
- Comfort/Stability Survey at Simulation(Baseline)