Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort

Обзор

This phase II trial studies the side effects of hypofractionated radiation therapy in treating patients with soft tissue sarcomas prior to surgery. 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.

Подробное описание

PRIMARY OBJCETIVES:

I. Grade \>= 2 radiation morbidity (subcutaneous tissue fibrosis, joint stiffness, or edema) at 2 years.

SECONDARY OBJECTIVES:

I. Evaluate local control, regional control, distant metastasis, progression free survival, and overall survival.

II. Evaluate the functional outcomes as assessed using the musculoskeletal tumor rating scale (MSTS) and the Toronto Extremity Salvage Score (TESS).

III. Collect germ-line deoxyribonucleic acid (DNA) and nucleic acids from cancer patients to further investigate the association and identify new germ-line mutations that impact cancer predisposition.

IV. Investigate the role of germ-line mutations in predicting cancer outcome and response to therapy.

OUTLINE:

Patients undergo hypofractionated radiation therapy on Monday-Friday for 5 days. Beginning 2-12 weeks after completion of radiation therapy, patients undergo surgery.

After completion of study treatment, patients are followed up at 3 months and then every 6 months for 5 years.

Вмешательства

• Процедура Conventional Surgery
  Undergo surgery
• Лучевая терапия Hypofractionated Radiation Therapy
  Undergo hypofractionated radiation therapy
• Другое Laboratory Biomarker Analysis
  Correlative studies
• Другое Questionnaire Administration
  Ancillary studies

Первичные конечные точки

• Grade >= 2 radiation morbidity (subcutaneous tissue fibrosis, joint stiffness, or edema) [Срок оценки: Up to 2 years]

Вторичные конечные точки (5)

• Distant metastasis [Срок оценки: Up to 3 years]
• Local failure [Срок оценки: Up to 3 years]
• Overall survival [Срок оценки: Up to 3 years]
• Progression free survival [Срок оценки: Up to 3 years]
• Regional failure [Срок оценки: Up to 3 years]

Критерии участия

Критерии включения

• Histologically confirmed soft tissue sarcoma of the extremity/trunk
• Intermediate or high grade sarcoma
• Resectable primary lesion (patients with pre-existing metastasis will be included if their primary is still going to be resected)
• Recurrent, any grade, no previous radiation therapy
• Karnofsky performance status (KPS) >= 70 or Eastern Cooperative Oncology Group (ECOG) 0 - 2
• If a woman is of childbearing potential, a negative serum pregnancy test must be documented

Критерии исключения

• Active treatment of a separate malignancy
• History of prior irradiation to the area to be treated
• Pre-operative chemotherapy (post-op acceptable)

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

• UCLA / Jonsson Comprehensive Cancer Center — Los Angeles

Публикации

• Nikitas J, Kendal JK, Savjani RR, Jackson N, Peterson N, Deng J, Hernandez J, Chong N, Singh AS, Chmielowski B, Federman NC, Crompton JG, Kadera BE, Wessel LE, Christ AB, Nelson SD, Dry SM, Weidhaas JB, Steinberg ML, Bernthal NM, Eilber FC, Kalbasi A, Reddy VK. Five-Day Preoperative Radiation Therapy for Patients With High-Risk Soft Tissue Sarcoma: A Nonrandomized Clinical Trial. JAMA Netw Open. 2 PMID 41405883

Идентификаторы

NCT: NCT02701153 · 15-001657 · NCI-2016-00202 · 15-001657

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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