IORT After Surgical Resection of Brain Metastases

NCT ID: NCT05084092

Last Updated: 2022-08-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-17
• Study Completion Date: 2024-12-31

Brief Summary

To evaluate the feasibility and efficacy of the Intraoperative Radiation Therapy (IORT) after the resection of a brain metastases to reduce the incidence of local relapse

Conditions

Brain Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intraoperative Radiotherapy (IORT)

Intraoperative Radiotherapy (IORT) administered during surgery

Group Type: EXPERIMENTAL

Intraoperative Radiotherapy (IORT)

Intervention Type: RADIATION

If biopsy is positive, local treatment with IORT will be performed. After IORT (15,40 Gray at 2 mm dept), the applicator will be removed and surgery will be continued in a standard fashion.

Brain surgery

Intervention Type: PROCEDURE

Surgery should be performed according to the local standard of care, preferentially as image-(neuronavigation) guided surgery. To establish the diagnosis of a metastasis and to exclude primary CNS tumors, lymphomas, SCLCs or germinomas it will be performed a peroperative biopsy

Interventions

Intraoperative Radiotherapy (IORT)

If biopsy is positive, local treatment with IORT will be performed. After IORT (15,40 Gray at 2 mm dept), the applicator will be removed and surgery will be continued in a standard fashion.

Intervention Type: RADIATION

Brain surgery

Surgery should be performed according to the local standard of care, preferentially as image-(neuronavigation) guided surgery. To establish the diagnosis of a metastasis and to exclude primary CNS tumors, lymphomas, SCLCs or germinomas it will be performed a peroperative biopsy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years, Karnofsky Performance Index ≥ 70.
• Newly diagnosed cerebral or cerebellar lesion (contrast enhancing on a T1- weighted MRI scan) amenable to total resection with no dural attachment.
• Frozen section confirming a metastasis of an extracranial (i.e. non-CNS) tumor.
• Adequate distance to optic nerve(s), chiasm and brainstem (organs at risk for radiotherapy).
• Adequate birth control.
• Informed consent.

Exclusion Criteria

• Leptomeningeal spread and dural attachment (assessed pre- and intraoperative).
• Frozen section reveals primary CNS tumor, lymphoma, SCLC or germinoma.
• Psychiatric or social condition potentially interfering with compliance.
• Contraindication against anesthesia, surgery, MRI and/or contrast agents.
• Pregnant or breast-feeding women.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut Català d'Oncologia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Miquel Macià, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Català d'Oncologia

Locations

Catalan Institute of Oncology

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Miquel Macià, MD

Role: CONTACT

mmacia@iconcologia.net

+34 93 260 77 20

Facility Contacts

Miquel Macià, MD

Role: primary

mmacia@iconcologia.net

+34 93 260 77 20

Anna Lucas, MD

Role: backup

alucas@iconcologia.net

+34 93 260 77 20

Other Identifiers

IORT_BRAIN_MET_2019

Identifier Type: -

Identifier Source: org_study_id