a Feasibility Study of iHD-SRT for BM

Brain Metastases, Adult Clinical Trial

Official title:

Isotoxic High Dose (iHD) Fractionated Stereotactic Radiation Therapy (fSRT) for Intact Brain Metastases : a Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06231186
• Other study ID #: 2024(006)
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: Ruijin Hospital
• Contact: Dan Ou, MD
• Phone: 8618801970632
• Email: od12341[@]rjh.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Brain metastasis is the most challenging disease in the field of tumor treatment, with a median overall survival of only 1-2 months for untreated patients. Stereotactic radiotherapy (SRT) has the advantages of precise positioning, relatively concentrated dosage, shorter course, and lower toxicity. Several studies could effectively protect cognitive function and achieve better tumor control rate. Currently, it has gradually replaced WBRT as standard local treatment choice for brain metastases. SRT includes Stereotactic Radiosurgery (SRS) and Fractional Stereotactic Radiotherapy (fSRT). With the continuous updating of domestic radiation therapy equipment, the use of high-resolution multi leaf gratings enables the accuracy of fSRT based on linear accelerators to reach 0.5mm or even lower levels, and has gradually become one of the main choices for local treatment of a limited number of patients with brain metastases.

However, there is currently no prospective randomized controlled study data analyzing the clinical benefits of different segmentation and dosages of SRT. In retrospective data comparing different segmentation schemes, researchers found that higher BED was associated with better local control. However, the ASTRO guidelines recommend relatively conservative doses for SRT of brain metastases, especially as the lesion volume increases, and the recommended dose of BED10 for SRT was only 48 Gy (30 Gy/5 Fx). This is based on the consideration that higher radiation exposure will bring a higher risk of radiation-induced brain necrosis. However, with the continuous updates of SRT treatment equipment and technology, existing technologies can achieve higher dose coverage for more brain metastases while meeting the normal tissue limit. Therefore, this study conducted a prospective intervention study to explore the feasibility and safety of optimizing SRT dosage based on normal tissue tolerance for the treatment of brain metastases, in order to further improve the therapeutic effect of intracranial lesions with brain metastases.

This study is designed as a single arm open prospective study, assuming that under this treatment regimen, the proportion of patients with lesion prescription dose BED10>50 Gy is 90%, and the incidence of radiation-induced brain necrosis within 1 year is 8.5%. The planned enrollment period is 2 years and follow-up period is 1 year. A total of 35 people need to be enrolled.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Ability to understand and willingness to participate the research and sign the consent form

• ECOG PS 0-2

• The primary or metastatic lesion was confirmed by pathological histology as a malignant tumor

• Head MRI diagnosis of brain metastasis with measurable lesions and technically feasible SRT (no more than 15 in number and 20cc in volume)

• Estimated survival time = 3 months

Exclusion Criteria:

• Diffuse brain metastases, or combined with meningeal metastases, or technically difficult to perform SRT

• With severe internal medicine complications or absolute contraindications for radiotherapy

• other sufficient reasons to be unqualified, such as potential non-compliance with the clinical protocol, etc

Related Conditions & MeSH terms

• Brain Metastases, Adult
• Brain Neoplasms
• Neoplasm Metastasis

Intervention

Radiation:
• iHD-SRT
received isotoxic individualized fSRT, with BED 10>50Gy and <100Gy, and strict OAR limits

Locations

Country	Name	City	State
China	Ruijin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of patients receiving BED 10 >50 Gy	proportion of patients receiving BED 10 >50 Gy	through treatment completion, an average of 1 month
Primary	the incidence of radiation-induced brain necrosis	The incidence of radiation-induced brain necrosis	1 year