UPRIGHT-PRO: Prospective Development Study of Upright Proton Therapy
ConditionProton Therapy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Any patient that doesn't meet the inclusion criteria
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Standard-of-Care Proton Therapy
RadiationParticipants receive standard-of-care proton therapy at Stanford. Treatment is not assigned by the study.
Treatment groups
450 Participants
are divided into 1 treatment groupGroup A: Participants Receiving Standard-of-Care Proton Therapy1 intervention
Trial outcomes
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.
Time frame
End of proton therapy (3 months)Secondary outcomes
1
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.
Time frame
Baseline and end of proton therapy (3 months)2
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.
Time frame
End of proton therapy (3 months)3
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.
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: