Pre-operative Hypofractionated Proton Therapy

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Rate of major wound complications [Срок оценки: 90 days after surgery]

Вторичные конечные точки (8)

• Incidence of acute grade ≥3 adverse events [Срок оценки: 2 years after treatment]
• Rate of local recurrence free survival [Срок оценки: 1 and 2 years after enrollment]
• Rate of metastasis free survival [Срок оценки: 1 and 2 years after enrollment]
• Rate of late grade ≥2 radiation toxicity [Срок оценки: median two year follow up]
• Musculoskeletal Tumor Rating Scale scores [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: through study conclusion (estimated 5 years from opening)]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Sibley Memorial Hospital — Washington D.C.

Публикации

• 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

Идентификаторы

NCT: NCT05917301 · SIB2289 · IRB00335181

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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