Pre-operative Hypofractionated Proton Therapy

NCT ID: NCT05917301

Last Updated: 2025-04-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-18
• Study Completion Date: 2032-12-31

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.

Conditions

Soft Tissue Sarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pre-operative hypofractionated proton therapy

Patients will have 5 fractions of proton therapy prior to surgical resection of their sarcoma.

Group Type: EXPERIMENTAL

hypofractionation

Intervention Type: RADIATION

This study is being done to see if hypofractionation in treating sarcoma, will also provide patients with a faster and safer treatment outcome.

Interventions

hypofractionation

This study is being done to see if hypofractionation in treating sarcoma, will also provide patients with a faster and safer treatment outcome.

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Robert L. Sloan Fund for Cancer Research

OTHER

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Curtland Deville, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Locations

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Curtiland Deville, MD

Role: CONTACT

cdeville@jhmi.edu

202-537-4788

Ryan Manuel

Role: CONTACT

rmanuel5@jhmi.edu

Facility Contacts

Curtiland Deville, MD

Role: primary

cdeville@jhmi.edu

202-537-4788

Dana Kaplin

Role: backup

dkaplin1@jhmi.edu

410-614-3950

References

Gogineni E, Chen H, Hu C, Boudadi K, Engle J, Levine A, Deville C Jr. Prospective phase II trial of preoperative hypofractionated proton therapy for extremity and truncal soft tissue sarcoma: the PRONTO study rationale and design. Radiat Oncol. 2024 May 14;19(1):56. doi: 10.1186/s13014-024-02447-0.

Reference Type: DERIVED

PMID: 38745333 (View on PubMed)

Other Identifiers

IRB00335181

Identifier Type: OTHER

Identifier Source: secondary_id

SIB2289

Identifier Type: -

Identifier Source: org_study_id