UPRIGHT-PRO: Prospective Development Study of Upright Proton Therapy

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.

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Key information

Conditions

Proton Therapy

Sex eligibility

All sexes

Study type

Observational

Primary location

Lucile Packard Children's Hospital Stanford, Palo Alto, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard-of-Care Proton Therapy

Radiation

Participants receive standard-of-care proton therapy at Stanford. Treatment is not assigned by the study.

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)

Time frame: Baseline and end of proton therapy (3 months)

Quality of life assessed using the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire. Total score ranges from 0 to 108, with higher scores indicating better quality of life.
Treatment Satisfaction (FACIT-TS-G)

Time frame: End of proton therapy (3 months)

Treatment satisfaction assessed using the Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-General (FACIT-TS-G) questionnaire. Total score ranges from 0 to 21, with higher scores indicating greater treatment satisfaction.
Comfort/Stability Survey at Simulation

Time frame: Baseline

Participant-reported comfort and perceived stability during upright and supine simulation, assessed using a custom survey. Total score ranges from 10 to 50, with higher scores indicating better quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Aryan Dwivedi

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Jul 16, 2026
Registry last updated: Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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