Stereotactic Body Radiotherapy in Patients With Rare Oligometastatic Cancers (OligoRARE)

Официальное название

Stereotactic Body Radiotherapy in Addition to Standard of Care Treatment in Patients With Rare Oligometastatic Cancers (OligoRARE): a Randomized, Phase 3, Open-label Trial

Обзор

This is a randomized open-label multicentre Phase III superiority study of the effect of adding SBRT to the standard of care treatment on overall survival in patients with rare oligometastatic cancers. Patients will be randomized in a 1:1 ratio between current standard of care treatment vs. standard of care treatment + SBRT to all sites of known metastatic disease. The primary objective of this trial is to assess if the addition of stereotactic body radiotherapy (SBRT) to standard of care treatment improves overall survival (OS) as compared to standard of care treatment alone in patients with rare oligometastatic cancers.

Вмешательства

• Лучевая терапия Stereotactic body radiotherapy
  Each lesion may be treated with 1, 3, or 5 SBRT fractions of 16-24 Gy, 24-33 Gy or 25-40 Gy, respectively, depending on the local practice and size \& location of oligometastases. Three-fraction regimens will deliver a fraction every second day, and five-fraction regimens are delivered daily. All treatments must be completed within 2 weeks (10 working days) in order to avoid delays in starting systemic therapy.
• Лучевая терапия Palliative RT
  Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications. Recommended dose fractionations in this arm will include 8 Gy in 1 fractions, 20 Gy in 5 fractions, and 30 Gy in 10 fractions. Patients in this arm should not receive stereotactic doses or radiotherapy boosts, unless there is a clearly known clinical benefit (e.g. stereotactic radiation

Первичные конечные точки

• Overall survival [Срок оценки: 7.5 years from first patient in]

Вторичные конечные точки (8)

• Progression-free survival [Срок оценки: 9 years from first patient in]
• Disease-specific survival [Срок оценки: 9 years from first patient in]
• Time to disease progression [Срок оценки: 9 years from first patient in]
• Time to development of new metastatic lesions [Срок оценки: 9 years from first patient in]
• Time to development of polymetastatic disease [Срок оценки: 9 years from first patient in]
• Adverse events graded according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0 [Срок оценки: 9 years from first patient in]
• Health-related quality of life evaluated using self-administered EORTC QLQ-C30 questionnaires [Срок оценки: 9 years from first patient in]
• Health-related quality of life evaluated using self-administered EQ-5D-5L questionnaires [Срок оценки: 9 years from first patient in]

Критерии участия

Критерии включения

• Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.
• Controlled primary tumour, defined as:
• at least 3 months since original tumour treated definitively, with no progression at primary site
• Total number of oligometastases of 1-5 including:
• Brain metastases amenable to radiosurgery or fractionated stereotactic radiotherapy patient who had neurosurgical resection before trial inclusion are allowed and resected brain metastases count to the total number of oligometastases
• All sites of disease can be safely treated based on the judgement of an experienced radiation oncologist
• ECOG score 0-2
• Life expectancy > 6 months
• Age 18 or older
• Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.

Критерии исключения

• Primary cancer of prostate, breast, lung or colorectal
• Serious medical comorbidities precluding radiotherapy:
• These include interstitial lung disease in patients requiring thoracic radiation, Crohn's disease in patients where the GI tract will receive radiotherapy, or ulcerative colitis where the bowel will receive radiotherapy and connective tissue disorders such as lupus or scleroderma.
• For patients with liver metastases, moderate/severe liver dysfunction (Child Pugh B or C)
• Substantial overlap with a previously treated radiation volume. Prior radiotherapy in general is allowed, as long as the composite plan meets dose constraints herein. For patients treated previously with radiation, biological effective dose calculations should be used to equate previous doses to the tolerance doses listed in the RTQA Guidelines. All such cases should be discussed with one of the study coordinators
• Brain metastases only, without extra-cerebral metastases
• Malignant pleural effusion, malignant ascites, meningeal carcinomatosis and peritoneal carcinomatosis
• Maximum size of 6 cm for lesions outside the brain, except:
• Bone metastases over 5 cm may be included, if in the opinion of the local radiation oncologist it can be treated safely (e.g. rib, scapula, pelvis)
• Clinical or radiologic evidence of symptomatic spinal cord compression. Patients can be eligible if surgical resection has been performed, but the surgical site counts toward the total of up to 3 metastases.
• Metastatic disease that invades any of the following: GI tract (including oesophagus, stomach, small or large bowel), mesenteric lymph nodes, or disseminated skin metastases and lymphangiosis
• Pregnant or breast feeding women
• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial

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

Открытое

Основная цель

Лечение

Центры проведения

Бельгия · 3 центра

• Institut Jules Bordet — Anderlecht
• Universitair Ziekenhuis Gent — Ghent
• Gasthuiszusters Antwerpen - Sint-Augustinus — Wilrijk

Франция · 2 центра

• Centre Oscar Lambret — Lille
• Gustave Roussy — Villejuif

Польша · 2 центра

• Medical University Of Gdansk — Gdansk
• Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research I — Warsaw

Швейцария · 2 центра

• Inselspital — Bern
• UniversitaetsSpital Zurich — Zurich

Великобритания · 2 центра

• University Hospitals Birmingham NHS Foundation Trust (UHB) - UHB-Queen Elisabeth Medical C — Birmingham
• Royal Marsden Hospital - site: Chelsea, London — London

Германия · 1 центр

• Universitaets Krankenhaus Eppendorf - Universitaetsklinikum Hamburg-Eppendorf KE - Univers — Hamburg

Италия · 1 центр

• Istituto Europeo di Oncologia — Milan

Идентификаторы

NCT: NCT04498767 · EORTC 1945

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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