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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants Receiving Standard-of-Care Proton Therapy | Participants with cancer receiving standard-of-care proton therapy at Stanford. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard-of-Care Proton Therapy | Radiation | Participants receive standard-of-care proton therapy at Stanford. Treatment is not assigned by the study. |
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| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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(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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aryan Dwivedi | Contact | aryand@stanford.edu | aryand@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Yuan J Rao, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucile Packard Children's Hospital Stanford | Palo Alto | California | 94304 | United States |
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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 |
| Stanford University | Palo Alto | California | 94304 | United States |
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