Proton TherapyNCT07708636
UPRIGHT-PRO: Prospective Development Study of Upright Proton Therapy
An observational study of Proton Therapy, run by Stanford University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Proton Therapy
- What is being tested?
- Standard-of-Care Proton Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 450 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2026to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Any patient that doesn't meet the inclusion criteria
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Lucile Packard Children's Hospital Stanford
Palo Alto, California, 94304
Aryan Dwivedi, aryand@stanford.edu
Yuan J Rao, MD
Stanford University
Palo Alto, California, 94304
Aryan Dwivedi, aryand@stanford.edu
Yuan J Rao, MD
About this study
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
- Being tested
- Standard-of-Care Proton Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard-of-Care Proton TherapyRadiation
Participants receive standard-of-care proton therapy at Stanford. Treatment is not assigned by the study.
| Study group | Role | What they receive |
|---|---|---|
| Participants Receiving Standard-of-Care Proton Therapy | Participants with cancer receiving standard-of-care proton therapy at Stanford. Receives: Radiation: Standard-of-Care Proton Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of proton therapy (3 months)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proton TherapyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuan J Rao, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708636
- Sponsor's protocol ID
- IRB-85278
- Status last verified
- Jul 2026
- First submitted
- 26 Jun 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UPRIGHT-PRO: Prospective Development Study of Upright Proton Therapy
- ClinicalTrials.gov ID
- NCT07708636
- Acronym / sponsor ID
- IRB-85278
- Conditions
- Proton Therapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Receiving Standard-of-Care Proton Therapy | – | Radiation: Standard-of-Care Proton TherapyParticipants with cancer receiving standard-of-care proton therapy at Stanford. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- Any patient that doesn't meet the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard-of-Care Proton TherapyParticipants receive standard-of-care proton therapy at Stanford. Treatment is not assigned by the study. | Radiation | Participants Receiving Standard-of-Care Proton Therapy |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
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Active, not recruitingPhase 3
Radiation Therapy With Protons or Photons in Treating Patients With Liver Cancer
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuan J Rao, MD principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Proton Therapy, run by Stanford University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aryan Dwivedi (aryand@stanford.edu, aryand@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of upright proton therapy (time frame: End of proton therapy (3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.