UPRIGHT-PRO: Prospective Development Study of Upright Proton Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard-of-Care Proton Therapy.
- Who it may be relevant to
- Registry conditions: Proton Therapy. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Radiation Standard-of-Care Proton Therapy
Participants receive standard-of-care proton therapy at Stanford. Treatment is not assigned by the study.
Primary outcome measures
- Feasibility of upright proton therapy [Time frame: End of proton therapy (3 months)]
Secondary outcome measures (3)
- Quality of Life (FACT-G) [Time frame: Baseline and end of proton therapy (3 months)]
- Treatment Satisfaction (FACIT-TS-G) [Time frame: End of proton therapy (3 months)]
- Comfort/Stability Survey at Simulation [Time frame: Baseline]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Lucile Packard Children's Hospital Stanford — Palo Alto
- Stanford University — Palo Alto
Identifiers
NCT: NCT07708636 · IRB-85278