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Pre-operative Hypofractionated Proton Beam Therapy for the Treatment of Primary or Locally Recurrent Soft Tissue Sarcoma of the Trunk and Extremities, PRONTO Trial
Trial Status: active
This phase II trial tests the safety and side effects of hypofractionated proton beam therapy (PBT) before surgery (pre-operative), and how well it works in treating patients with soft tissue sarcoma (STS) of the trunk or extremity that is the first occurrence (primary) or that has come back at or near the original site after a period of improvement (locally recurrent). PBT is a type of radiation therapy that uses streams of protons (tiny particles with a positive charge) that come from a special machine. This type of radiation kills tumor cells but does not damage nearby tissues. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Because PBT delivers less radiation to normal tissues outside of the tumor, it may have fewer side effects, such as wound healing complications after surgery. Giving pre-operative hypofractionated PBT may provide patients with primary or locally recurrent STS a faster and safer treatment outcome.
Inclusion Criteria
Adult patients (≥ 18 years of age)
Patients with primary or locally recurrent extremity or truncal soft tissue sarcoma
Patients who will be having pre-operative radiation therapy as determined by their clinician
World Health Organization (WHO)/Eastern Cooperative Oncology Group (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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05917301.
I. Evaluate the rate of major wound complications in patients receiving pre-operative hypofractionated PBT occurring within 90 days after surgery.
SECONDARY OBJECTIVES:
I. Evaluate the safety and tolerability of pre-operative hypofractionated PBT for primary resectable STS.
II. Evaluate 1-year and 2-year local recurrence-free survival (LRFS) and metastasis-free survival (MFS) rates for patients receiving pre-operative hypofractionated PBT and resection.
III. Evaluate the rate of late grade ≥ 2 toxicity for patients with primary resectable STS receiving pre-operative hypofractionated PBT followed by surgical resection.
IV. Evaluate functional outcomes after hypofractionated PBT and surgery.
V. Evaluate quality of life after hypofractionated PBT and surgery.
VI. Evaluate pathologic response in surgical specimen after hypofractionated PBT.
OUTLINE:
Patients undergo hypofractionated PBT once every other weekday for 5 treatment fractions in the absence of disease progression or unacceptable toxicity. Patients then undergo surgical resection within 2-12 weeks of completing radiation therapy. Additionally, patients undergo computed tomography (CT) with or without magnetic resonance imaging (MRI) during screening, cone-beam CT (CBCT) and x-rays for PBT planning during treatment, and chest CT or chest X-ray, and MRI and/or CT of the primary disease site throughout the study.
After completion of study treatment, patients are followed up every 3-6 months for up to 2 years.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
