Stereotactic Radiotherapy Management of Brain Metastases: the Value of a Longitudinal Multimodal Approach (POSTPONE)

NCT06029140 | Unknown

• 1 other identifier: 29BRC23.0143 - POSTPONE
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

The management of brain metastases has evolved́ rapidly in recent years. It is estimated that 20% to 40% of cancer patients will develop brain metastases (BM) during the course of their disease. Whole-brain radiotherapy has long been the first-line treatment for brain metastases. However, large-scale international clinical trials conducted over the past decade have established stereotactic radiotherapy (SR) as the treatment of choice for the management of brain metastases (BM). However, even though the method of radiation delivery has evolved considerably, the problem of monitoring and managing brain metastases remains unresolved. This study therefore has several focuses:

1. 1.Evaluation of the benefit of early remnographic assessment (6 weeks): impact on recurrence-free survival and overall survival.
2. 2.Evaluation of a diagnostic approach to radionecrosis: complementarity of DOPA PET and multimodal MRI.
3. 3.The benefits of longitudinal remnographic monitoring with the development of segmentation and automated follow-up tools

Conditions

Brain Metastases, Adult

Keywords

stereotactic radiotherapy; radionecrosis; local relapse; PET DOPA; Multimodal MRI

Outcome Measures

Primary Outcomes (1)

• Risk factors of radionecrosis

  The main objective is to identify risk factors for cerebral radionecrosis after stereotactic radiotherapy in patients treated for brain metastases.

  Through study completion, an average of 1 year

Secondary Outcomes (2)

• Risk factors of local relapse

  Through study completion, an average of 1 year

• Post-SRT follow-up

  Through study completion, an average of 1 year

Other Outcomes (2)

• Automatic segmentation of brain metastasis

  Through study completion, an average of 1 year

• Automatic follow-up

  Through study completion, an average of 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient treated with intracerebral stereotactic radiotherapy at the Brest University Hospital as part of the management of a secondary localization of a primary solid cancer.

You may qualify if:

• Age ≥ 18 years
• Patients with solid cancer with brain metastases treated by hypofractionated external stereotactic radiotherapy at the CHRU de Brest between 01/01/2014 and 31/12/2022
• Patient affiliated to a social security scheme

You may not qualify if:

• Patients with primary brain tumors
• Patients treated with normofractionated external cerebral radiotherapy
• Age \< 18 years
• Patients under legal protection (guardianship, curatorship, etc.)

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Chu Brest

Brest, 29609, France

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Vincent Bourbonne, MD, PhD

  Radiation Oncology Department, Brest University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent BOURBONNE, MD, PhD

CONTACT

+33298223398; vincent.bourbonne@chu-brest.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: September 8, 2023
• Study Start: August 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: September 1, 2024
• Last Updated: August 9, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

Locations

FR (1)