Actively Recruiting
Isotoxic High Dose (iHD) Fractionated Stereotactic Radiation Therapy for Brain Metastases: a Feasibility Study
Led by Ruijin Hospital · Updated on 2024-04-10
35
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Brain metastasis is a serious condition with limited survival for untreated patients, typically only 1-2 months. Researchers are studying isotoxic high dose fractionated stereotactic radiation therapy (iHD-SRT) as a local treatment to improve tumor control while protecting brain function. This trial explores optimizing stereotactic radiotherapy (SRT) dosage based on normal tissue tolerance to enhance treatment effects for brain metastases, addressing the lack of prospective data comparing different SRT dosages and fractionation schemes. Participants will receive iHD-SRT, a precise radiation therapy using high-resolution equipment to deliver individualized doses with biologically effective dose (BED10) greater than 50 Gy but less than 100 Gy. This approach aims to maximize tumor control while respecting organ-at-risk limits to reduce brain toxicity. The study is a single-arm, open-label, prospective trial enrolling 35 patients over two years, followed by one year of monitoring. During the study, participants will undergo treatment with iHD-SRT and be closely monitored for treatment completion and side effects, especially radiation-induced brain necrosis within one year. The main outcomes measured are the proportion of patients receiving the targeted radiation dose and the incidence of brain necrosis. Follow-up will assess safety and feasibility, with an expected total involvement of three years from treatment start to final evaluation.
CONDITIONS
Brief Title
a Feasibility Study of iHD-SRT for BM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and willing to participate and sign the consent form
- ECOG Performance Status 0 to 2
- Malignant tumor confirmed by pathological histology
- Brain metastases confirmed by head MRI with measurable lesions no more than 15 in number and total volume no more than 20cc
- Estimated survival time of at least 3 months
You will not qualify if you...
- Diffuse brain metastases or meningeal metastases or technically difficult to perform stereotactic radiotherapy
- Severe internal medicine complications or absolute contraindications for radiotherapy
- Other reasons such as potential non-compliance with the clinical protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 1 month
Participants receive isotoxic high dose fractionated stereotactic radiation therapy (iHD-SRT) for brain metastases.
Multiple visits during treatment period
Trial Site Locations
Total: 1 location
1
Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
Research Team
D
Dan Ou, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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