Pre-operative Hypofractionated Proton Therapy

NCT05917301 | Recruiting DMC

• 2 other identifiers: SIB2289IRB00335181
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

proton therapy; soft tissue sarcoma; hypofractionated

Outcome Measures

Primary Outcomes (1)

• Rate of major wound complications

  Number of major wound complications as defined by the CAN-NCIC-SR2 trial ("secondary operation under general or regional anaesthesia for wound repair (debridement, operative drainage, and secondary wound closure including rotationplasty, free flaps, or skin grafts), or wound management without secondary operation…\[including\] an invasive procedure without general or regional anaesthesia (mainly aspiration of seroma), readmission for wound care such as intravenous antibiotics, or persistent deep packing for 120 days or longer.")

  90 days after surgery

Secondary Outcomes (8)

• Incidence of acute grade ≥3 adverse events

  2 years after treatment

• Rate of local recurrence free survival

  1 and 2 years after enrollment

• Rate of metastasis free survival

  1 and 2 years after enrollment

• Rate of late grade ≥2 radiation toxicity

  median two year follow up

• Musculoskeletal Tumor Rating Scale scores

  baseline, 2-12 weeks after end of radiation therapy, after surgery (3-6 month follow up), every 3 months during follow up for 2 years

Study Arms (1)

Pre-operative hypofractionated proton therapy

EXPERIMENTAL

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

Radiation: hypofractionation

Interventions

hypofractionation RADIATION

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

Pre-operative hypofractionated proton therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥18 years of age)
• Patients with primary or locally recurrent extremity or truncal soft tissue sarcoma
• WHO/ECOG status ≤2

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Robert L. Sloan Fund for Cancer Research: collaborator

Study Sites (1)

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 38745333 DERIVED

MeSH Terms

Conditions

Sarcoma

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Study Officials

• Curtland Deville, MD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Curtiland Deville, MD

CONTACT

202-537-4788; cdeville@jhmi.edu

Ryan Manuel

CONTACT

rmanuel5@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 23, 2023
• Study Start: April 18, 2024
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2032
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

US (1)