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NCT05917301 | RECRUITING | Soft Tissue Sarcoma

Pre-operative Hypofractionated Proton Therapy
Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

Condition or disease

Soft Tissue Sarcoma

Intervention/treatment

hypofractionation

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : PROspective Phase II Trial of Pre-operative Hypofractionated protoN Therapy for Extremity and Truncal Soft Tissue sarcOma
Actual Study Start Date : 2024-04-18
Estimated Primary Completion Date : 2030-12
Estimated Study Completion Date : 2032-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Pre-operative Hypofractionated Proton Therapy

Location Details

NCT05917301

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, District of Columbia

Sibley Memorial Hospital

Washington, District of Columbia, United States, 20016