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.

Study Overview

• Status: Not yet recruiting
• Conditions: Proton Therapy
• Intervention / Treatment: Radiation: Standard-of-Care Proton Therapy

• Study Type: Observational
• Enrollment (Estimated): 450

Contacts and Locations

• Study Contact: Name: Aryan Dwivedi; Phone Number: aryand@stanford.edu; Email: aryand@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University
      • Contact: Aryan Dwivedi; Email: aryand@stanford.edu
      • Principal Investigator: Yuan J Rao, MD
    • Palo Alto, California, United States, 94304
      • Lucile Packard Children's Hospital Stanford
      • Contact: Aryan Dwivedi; Email: aryand@stanford.edu
      • Principal Investigator: Yuan J Rao, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants Receiving Standard-of-Care Proton Therapy; Participants with cancer receiving standard-of-care proton therapy at Stanford.	Radiation: Standard-of-Care Proton Therapy; Participants receive standard-of-care proton therapy at Stanford. Treatment is not assigned by the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life (FACT-G)	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.	Baseline and end of proton therapy (3 months)
Treatment Satisfaction (FACIT-TS-G)	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.	End of proton therapy (3 months)
Comfort/Stability Survey at Simulation	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.	Baseline

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Yuan J Rao, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: June 26, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: IRB-85278

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No