Single Fraction Stereotactic Radiosurgery Compared With Fractionated Stereotactic Radiosurgery in Treating Patients With Resected Metastatic Brain Disease

Titre officiel

Phase III Trial of Post-Surgical Single Fraction Stereotactic Radiosurgery (SRS) Compared With Fractionated SRS for Resected Metastatic Brain Disease

Sommaire:

Cet essai de phase III étudie l’efficacité de la radiochirurgie stéréotaxique unique par rapport à celle de la radiochirurgie stéréotaxique fractionnée dans le traitement des patients atteints d’un cancer qui s’est propagé au cerveau à partir d’autres parties du corps et qui a été réséqué. La radiochirurgie stéréotaxique unique est une radiothérapie spécialisée qui délivre une seule dose élevée de rayonnement directement sur la tumeur et qui peut causer moins de dommages aux tissus normaux. La radiochirurgie stéréotaxique fractionnée permet d’administrer de multiples doses plus faibles de radiothérapie en plusieurs séances. Cette étude pourrait aider les médecins à déterminer si la radiochirurgie stéréotaxique fractionnée est meilleure ou pire que l’approche habituelle de la radiochirurgie stéréotaxique unique.

Description de l'essai

Primary Outcome:

• Surgical bed recurrence-free survival (SB-RFS)

Secondary Outcome:

• Change in Functional Assessment of Cancer Therapy-Brain (FACT-BR) Emotional sub-scale score
• Functional Assessment of Cancer Therapy-Brain (FACT-BR) total score
• Linear Analog Self-Assessment (LASA) overall quality of life
• Functional Assessment of Cancer Therapy-Brain (FACT-BR) Emotional sub-scale score for long-term survivors
• Functional Assessment of Cancer Therapy-Brain (FACT-BR) total score for long-term survivors
• Linear Analog Self-Assessment (LASA) overall quality of life for long-term survivors
• Karnofsky Performance Status (KPS)
• Barthel Activities of Daily Living (ADL) Index
• Karnofsky Performance Status (KPS) for long-term survivors
• Barthel Activities of Daily Living (ADL) Index for long-term survivors
• Overall survival
• Incidence of adverse events
• Proportion of patients with radiation necrosis
• Time until whole-brain radiation therapy (WBRT) due to any reason (e.g. surgical bed recurrence, recurrence/progression at another central nervous system [CNS] site)

PRIMARY OBJECTIVES:

• To ascertain if time to surgical bed failure is increased with fractionated stereotactic radiosurgery (FSRS) compared to single-fraction stereotactic radiosurgery (SSRS) in patients with resected brain metastasis.

SECONDARY OBJECTIVES:

• To ascertain if there is better emotional well-being at 9 months as assessed by the Functional Assessment of Cancer Therapy-Brain (FACT-BR) in patients with resected brain metastasis undergoing FSRS compared to SSRS (Primary quality of life [QOL] objective).
• To ascertain whether there is improved overall survival in patients with resected brain metastases who undergo FSRS compared to patients who receive SSRS.
• To ascertain in patients with resected brain metastases whether there is improved overall QOL as assessed by the FACT-BR and Linear Analog Self-Assessment (LASA) in patients who receive FSRS compared to patients who receive SSRS (Secondary QOL objective).
• To compare the functional independence in patients who receive FSRS to patients who receive SSRS.
• To tabulate and descriptively compare the post-treatment adverse events associated with the interventions, including the potential impact of immunotherapy and targeted therapy.
• To compare rates of radiation necrosis at 12 months in patients who receive FSRS to patients who receive SSRS.
• To evaluate if there is any difference in central nervous system (CNS) failure patterns (local, distant brain failure, local leptomeningeal disease, widespread leptomeningeal disease) in patients who receive FSRS compared to patients who receive SSRS after resection of brain metastasis.
• To ascertain in patients with resected brain metastases whether there is increased time to whole-brain radiation therapy (WBRT) in patients who receive FSRS compared to patients who receive SSRS.
• To determine in long-term survivors (patients who are alive more than 12 months from time of randomization) whether there is better emotional well-being and overall QOL as assessed by the FACT-BR and LASA in patients who receive FSRS to the surgical bed compared to patients who receive SSRS (Secondary QOL objective).
• To ascertain if time to surgical bed failure as assessed by central review is increased with FSRS compared to SSRS in patients with resected brain metastasis.
• To ascertain in patients with resected brain metastases whether there is improved QOL as assessed by all other total and individual FACT-BR and LASA items and subscale values in patients who receive FSRS compared to patients who receive SSRS (Exploratory QOL objective).
• To determine in patients with resected brain metastases whether there is less cognitive progression in patients who receive FSRS to the surgical bed compared to patients who receive SSRS (Exploratory cognitive objective).

OUTLINE:
Patients are randomized to 1 of 2 arms. ARM I: Patients undergo SSRS over 1 session. ARM II: Patients undergo FSRS over 3 or 5 daily sessions. After completion of study, patients are followed up at 30 days, at 3, 6, 9, 12, 16, and 24 months, then every 6 months until 5 years from randomization.

Voir cet essai sur ClinicalTrials.gov