Adaptive Fractionation in Online Adaptive Stereotactic Radiotherapy for Abdominopelvic Lymph Node Oligometastases

Обзор

Oligometastases, a state of cancer with up to five metastases, was traditionally treated with systemic treatments like chemotherapy. Treatment with stereotactic body radiotherapy (SBRT) showed a high local control and improved disease-free survival. The use of SBRT also allows for the deferral of systemic treatment, thereby delaying its potential side effects. SBRT enables the delivery of a high dose to the tumor while minimizing the dose to organs at risk, reducing normal tissue damage, however, toxicity remains a potential issue in the abdominopelvic region, where lymph node oligometastases are often located near highly mobile, radiosensitive organs like the bowel. Online adaptive radiotherapy is used to address this issue, adapting the treatment plan to the anatomy of the day. Unfortunately, adaptive radiotherapy results in longer treatment delivery times than conventional radiotherapy. This can potentially be countered by increasing the fraction dose and reducing the number of fractions if the patient anatomy allows it. This is convenient for the patient as it reduces the number of hospital visits, and it could also reduce the total workload for the hospital. Therefore, there is not only a benefit of a reduction in toxicity by adaptive treatment, but also in reducing the total treatment time. This study aims to investigate if the number of adaptive fractions can be reduced by 30% for patients with abdominal or pelvic lymph node oligometastases.

Вмешательства

• Лучевая терапия Online-Adaptive SBRT
  The treatment will consist of online-adaptive SBRT using the ETHOS linear accelerator. The standard treatment will be 45 Gy in 5 fractions (45Gy/5Fx). If the patient anatomy allows, the number of planned fractions will be isotoxically reduced, keeping OAR and target dose goals biologically equivalent, to a minimum of 25 Gy in 1 fraction (25Gy/1Fx). For the adaptive treatment, daily HyperSight CBCT scans will be made, and the target and OAR contours will be automatically delineated and adjusted

Первичные конечные точки

• Proportion of participants achieving ≥30% reduction in number of online-adaptive fractions compared with the standard 5-fraction SBRT course. [Срок оценки: From enrollment to the end of treatment at 1 month.]

Вторичные конечные точки (6)

• Overall survival (time-to-event in months) from start of SBRT [Срок оценки: From first day of treatment up to 48 months.]
• Local control at the treated site assessed by RECIST v1.1 [Срок оценки: At 12, 24, and 36 months after treatment.]
• Participants with treatment-related acute adverse events (CTCAE v5.0) [Срок оценки: From first day of treatment to 90 days after last fraction.]
• Participants with treatment-related late adverse events (CTCAE v5.0) [Срок оценки: >90 days after last fraction to 24 months.]
• Magnitude of intra- and interfraction bowel displacement on CBCT (mm) [Срок оценки: Assessed at each delivered fraction from the first fraction through the final delivered fraction (up to 5 fractions over up to 2 weeks).]
• Treatment fractions requiring patient re-alignment due to intrafraction motion (CBCT-guided adaptive workflow) [Срок оценки: Assessed at each delivered fraction from the first fraction through the final delivered fraction (up to 5 fractions over up to 2 weeks).]

Критерии участия

Критерии включения

• Patients with abdominal and/or pelvic lymph node recurrences of solid tumors.
• No more than 5 metastatic lesions in no more than 2 organs and a controlled primary tumor site.
• Diagnostic imaging includes at least a PET scan or CT thorax/abdomen, of which one is not older than 4 weeks at the time of referral for SBRT.
• Primary tumor must be treated at least 4 months before the diagnosis of metastasis.
• Patients must be 18 years or older.
• Written informed consent.

Критерии исключения

• Prior radiotherapy in the same field.
• Second primary malignancy except in situ carcinoma of the cervix, adequately treated non-melanoma skin cancer, or other malignancy treated at least 3 years.
• Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.

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

Нидерланды · 1 центр

• Erasmus MC — Rotterdam

Идентификаторы

NCT: NCT07415356 · NL-OMON57107

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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