Neoadjuvant Stereotactic Radiotherapy for Brain Metastasis - Prospective Trial NeoSTROBE
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 260
- Locations
- 4
- Primary Endpoint
- Acute Toxicity
Study Overview
Brief Summary
This multicentre proof-of-concept study, involving 4 centers, aims to establish the value of fractionated neoadjuvant stereotactic radiotherapy (NaSRT) as a new treatment paradigm for brain metastases (BM) in the frame of the Czech neurooncology network. Most relevant studies published to date used single-fraction radiotherapy and dealt with the inherent bias related to their retrospective nature. The researchers aim to increase the level of evidence for this treatment paradigm together with other similar ongoing studies.
Detailed Description
The prospective study will evaluate the efficacy and toxicity of neoadjuvant stereotactic radiotherapy (NaSRT) in patients with brain metastases (BM). Clinical data gathered will include local control (LC), the incidence of leptomeningeal disease (LMD), radiological and clinical signs of radiation necrosis (RN), overall survival, and incidence of metachronous brain metastases. The magnetic resonance imaging (MRI) characteristics of irradiated and subsequently resected BM will be obtained according to the usual protocol and specified time intervals. Clinical monitoring will comprise neurological findings, Karnofsky performance status, and quality of life (FACT-Br/EORTC QLQ-C30 questionnaire and EORTC QLQ-BN20 questionnaire. These questionnaires are designed to measure cancer patients' physical, psychological, and social functions. The questionnaires are composed of multi-item scales and single items). The data obtained from the retrospective control group (estimated for 160 patients) will include the same parameters monitored in the consecutive group of patients who underwent surgery at centers included in our study, with or without adjuvant radiotherapy (RT). Formation of this control group corresponding to the NaSRT group will enable the efficacy and risks of NaSRT to be determined in comparison with established treatment modalities.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
No masking will be used in the study.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years
- •Karnofsky Performance Status ≥ 60
- •Histologically verified primary cancer disease
- •MRI findings indicating BM
- •Target BM indicated for surgical resection and any other metastases suitable for radical SRT.
- •Target BM between 1 cm and 7 cm at the longest diameter on T1 post-contrast MR imaging
Exclusion Criteria
- •Confirmed hematological malignity
- •Small-cell (lung) carcinoma
- •Peracute condition requiring immediate neurosurgical intervention
- •History of whole-brain radiotherapy (WBRT)
- •History of stereotactic radiotherapy to a target brain metastasis
- •Pregnancy
- •Inability to perform surgical resection of the target BM within 7 days after NaSRT
Arms & Interventions
Neoadjuvant NaSRT - prospective
Patients undergoing neoadjuvant NaSRT will be enrolled prospectively in this study arm.
Intervention: Neoadjuvant Stereotactic Radiotherapy (NaSRT) (Radiation)
Postoperative SRT - retrospective
Patients who underwent postoperative SRT in the past will be analyzed retrospectively in this study arm.
Intervention: Postoperative Stereotactic Radiotherapy (SRT) (Radiation)
Outcomes
Primary Outcomes
Acute Toxicity
Time Frame: 3 months
Acute Toxicity will be assessed in the study subjects according to Common Terminology Criteria for Adverse Events (CTCAE) ver. 5 to 10%.
Quality of Life Questionnaire (FACT-Br/EORTC QLQ-C30)
Time Frame: 3 months
Quality of Life will be assessed in the study subjects using the FACT-Br/EORTC QLQ-C30 questionnaire.
Quality of Life Questionnaire (EORTC QLQ-BN20)
Time Frame: 3 months
Quality of Life will be assessed in the study subjects using the EORTC QLQ-BN20 questionnaire.
Secondary Outcomes
- Time from NaSRT to detection of LMD(3 years)
- Time from NaSRT to local progression(3 years)
- Time from NaSRT to the onset of RN(3 years)
- Overall Survival(3 years)
- Time from NaSRT to detection of distant parenchymal metastasis(3 years)