Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Metastatic Cancer

Официальное название

Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Metastatic Cancer: A Phase II Randomized Trial

Обзор

A registry-based randomized phase II trial. A total of 46 patients with metastatic cancer on systemic therapy with oligoprogression to 1-5 extracranial lesions will be randomized using a 1:1 ratio to standard of care (begin next-line systemic therapy, best supportive care, continue current systemic line, based on treating physician decision) vs. receive stereotactic ablative radiotherapy to all oligoprogressive lesions while continuing their current systemic therapy.

Вмешательства

• Другое Standard arm
  Patients on the standard arm will be treated as per standard of care in our institution. Treatment options could include switching to next systemic therapy line, best supportive care or continuing on current systemic therapy.
• Лучевая терапия Experimental arm
  SABR to all oligoprogressive lesions + continuation of current systemic therapy

Первичные конечные точки

• Progression free survival [Срок оценки: 5 years]

Вторичные конечные точки (5)

• Overall survival [Срок оценки: 5 years]
• Quality of life Measured using the FACT-G tool, patient reported outcome- CTCAE (PRO-CTCAE) and Quality of life 5-level EQ-5D [Срок оценки: 5 years]
• Grade ≥ 3 toxicity Measured using the Common Terminology Criteria for Adverse Events (CTCAE v5.0) [Срок оценки: 5 years]
• Local control [Срок оценки: 5 years]
• Time to next systemic therapy [Срок оценки: 5 years]

Критерии участия

Критерии включения

• Age ≥18 years
• Metastatic cancer (any histology), with pathological or radiological proof of metastasis
• Ability to provide written informed consent
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Progressive disease while on systemic treatment (any line), defined as per RECIST criteria 1.1 on CT metrics as a greater than 20% increase in the sum measurement of lesions, non-target unequivocal progressive disease or a new lesion on CT.
• Oligoprogression to 1-5 extracranial lesions ≤ 5cm and involving ≤ 3 organs. Progression at the primary tumor site should be counted within the total of 5 lesions. For patients with lymph node metastases, each node is counted as one site of metastasis.
• All sites of disease can, in the opinion of the investigator, be safely treated and targetable with SABR (taking into account prior local therapy, organ function and underlying medical condition such as inflammatory bowel disease, pulmonary fibrosis, etc.)
• Patients with prior metastases that have been treated with ablative therapies (e.g. radiotherapy, surgery or radiofrequency ablation) before their current line of systemic therapy, are eligible.

Критерии исключения

• Pregnancy or breastfeeding
• Any medical condition that could, in the opinion of the investigator, preclude radiotherapy or prevent follow-up after radiotherapy.
• Presence of spinal cord compression
• Metastatic disease that invades the GI tract (including esophagus, stomach, small or large bowel

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Centre Hospitalier de l'Université de Montréal — Montreal

Идентификаторы

NCT: NCT04989725 · Suppress

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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