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Recruiting NCT05917301

Pre-operative Hypofractionated Proton Therapy

No phase Interventional Soft Tissue Sarcoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: hypofractionation.
Who it may be relevant to
Registry conditions: Soft Tissue Sarcoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

PROspective Phase II Trial of Pre-operative Hypofractionated protoN Therapy for Extremity and Truncal Soft Tissue sarcOma

Overview

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.

Interventions

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

Primary outcome measures

  • Rate of major wound complications [Time frame: 90 days after surgery]
Secondary outcome measures (8)
  • Incidence of acute grade ≥3 adverse events [Time frame: 2 years after treatment]
  • Rate of local recurrence free survival [Time frame: 1 and 2 years after enrollment]
  • Rate of metastasis free survival [Time frame: 1 and 2 years after enrollment]
  • Rate of late grade ≥2 radiation toxicity [Time frame: median two year follow up]
  • Musculoskeletal Tumor Rating Scale scores [Time frame: 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]
  • Toronto Extremity Salvage Score (TESS) scores [Time frame: 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]
  • Functional Assessment of Cancer Therapy-General (FACT-G) scores [Time frame: 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]
  • Rate of pathologic complete response [Time frame: through study conclusion (estimated 5 years from opening)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Sibley Memorial Hospital — Washington D.C.

Publications

  • 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

Identifiers

NCT: NCT05917301 · SIB2289 · IRB00335181

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗