Proton Therapy
Conditions
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.
Interventions
RADIATIONStandard-of-Care Proton Therapy
Participants receive standard-of-care proton therapy at Stanford. Treatment is not assigned by the study.
Sponsors
Stanford University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of upright proton therapy | 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (FACT-G) | 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) | 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 | 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. |
Countries
United States
Contacts
CONTACTAryan Dwivedi
PRINCIPAL_INVESTIGATORYuan J Rao, MD
Stanford University
Outcome results
None listed