UPRIGHT-PRO: Prospective Development Study of Upright Proton Therapy

NCT07708636 | Not Yet Recruiting

• 1 other identifier: IRB-85278
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 2

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.

Conditions

Proton Therapy

Outcome Measures

Primary Outcomes (1)

• Feasibility of upright proton therapy

  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.

  End of proton therapy (3 months)

Secondary Outcomes (3)

• 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

Study Arms (1)

Participants Receiving Standard-of-Care Proton Therapy

Participants with cancer receiving standard-of-care proton therapy at Stanford.

Radiation: Standard-of-Care Proton Therapy

Interventions

Standard-of-Care Proton Therapy RADIATION

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

Participants Receiving Standard-of-Care Proton Therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

(i) Up to 450 participants are expected to be enrolled at Stanford-affiliated site(s). (ii) The total number of participants expected to enroll across all sites is 450, as this is a single-site study conducted at Stanford-affiliated facilities. (iii) Participants will be pediatric and adult patients with cancer who are being considered for treatment with upright proton therapy as part of their standard clinical care. These participants are appropriate for the study because the purpose is to evaluate the feasibility of delivering upright proton therapy in patients who would otherwise be eligible for proton radiation treatment.

You may qualify if:

• 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)

Sponsors & Collaborators

• Stanford University: lead

Study Sites (2)

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

Study Officials

• Yuan J Rao, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aryan Dwivedi

CONTACT

aryand@stanford.edu; aryand@stanford.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 16, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

US (2)