NCT05917301 Pre-operative Hypofractionated Proton Therapy
| NCT ID | NCT05917301 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| Condition | Soft Tissue Sarcoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-04-18 |
| Primary Completion | 2030-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-04-18 with a primary completion date of 2030-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is being done to examine whether proton therapy for certain kinds of sarcomas (extremity and trunk soft tissue) is safe and effective. As part of the study, patients will have five fractions of proton therapy before the participants have surgery for the sarcoma. The study will measure wound complications and functional outcomes / quality of life after the procedures. Patients will be asked to complete questionnaires about the treatment and quality of life from the time of enrollment until about two years after surgery. Otherwise, the participants will have standard of care follow ups with the treatment team.
Eligibility Criteria
Inclusion Criteria: * Adult patients (≥18 years of age) * Patients with primary or locally recurrent extremity or truncal soft tissue sarcoma * WHO/ECOG status ≤2 Exclusion Criteria: * History of prior local radiation therapy * Inability to tolerate treatment position for duration of simulation or treatment * Tumor originating in retroperitoneal location * Patients planned for systemic therapy including chemotherapy, targeted agents, and immunotherapy * Co-existing malignancy or treated malignancy in the last 2 years expected to limit life expectancy; does not include completely resected cutaneous basal cell carcinoma, squamous cell carcinoma, in situ breast or cervical malignancies, or other pathologies at the discretion of the investigators. * Confirmed pregnancy.
Contact & Investigator
Curtland Deville, MD
PRINCIPAL INVESTIGATOR
Johns Hopkins School of Medicine
Frequently Asked Questions
Who can join the NCT05917301 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Soft Tissue Sarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05917301 currently recruiting?
Yes, NCT05917301 is actively recruiting participants. Contact the research team at cdeville@jhmi.edu for enrollment information.
Where is the NCT05917301 trial being conducted?
This trial is being conducted at Washington D.C., United States.
Who is sponsoring the NCT05917301 clinical trial?
NCT05917301 is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The principal investigator is Curtland Deville, MD at Johns Hopkins School of Medicine. The trial plans to enroll 40 participants.