Intraoperative Radiotherapy in Patients With Brain Metastases

NCT04847284 | Recruiting

• 1 other identifier: 2020/9548/I
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Intraoperative radiotherapy (IORT) is a new alternative for local radiotherapy with the advantages of dose escalation, reduced overall treatment time, and enhanced patient convenience, however the degree of efficacy is unknown, as well as and which is the most efficient dose. The objective of this study is to evaluate the efficacy and safety of IORT in patients with surgical excision of brain metastases at a dose of 20 Gy is at least as effective and safe as other forms of radiation therapy in patients with resection of brain metastases.

Conditions

Brain Metastases

Keywords

Brain metastases; Intraoperative radiotherapy; Intrabeam

Outcome Measures

Primary Outcomes (3)

• Median local progression free survival (lPFS)

  Recurrence within a 0.5 cm margin around the resection cavity, assessed by serial magnetic resonance imaging (MRI scans) and response assessment criteria in neuro-oncology (RANO)

  6 months from the date of surgery.

• Radiation-related acute neurotoxicity

  Neurotoxicity related to radiotherapy evaluated according to the scale of the Common Terminology Criteria for Adverse Events (CTCAE) version 5. Score from 0 to 5, with 5 being the worst toxicity \- Acute toxicity: cerebral edema

  3 months from the date of surgery.

• Radiation-related late neurotoxicity

  Neurotoxicity related to radiotherapy evaluated according to the scale of the Common Terminology Criteria for Adverse Events (CTCAE) version 5. Score from 0 to 5, with 5 being the worst toxicity \- Late toxicity: radionecrosis.

  6 months from the date of surgery.

Secondary Outcomes (3)

• Median regional PFS (rPFS)

  6 months from the date of surgery

• Global PFS (gPFS)

  6 months from the date of surgery

• Median overall survival (OS)

  6 months from the date of surgery

Study Arms (1)

Single arms

EXPERIMENTAL

To determine the efficiency and safety of IORT with low-energy photons to the cavity after resection of brain metastases

Radiation: Intraoperative radiotherapy

Interventions

Intraoperative radiotherapy RADIATION

Intraoperative radiotherapy application immediately following resection of brain metastases.

Single arms

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Karnofsky Performance Status ≥ 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 ( Central Nervous System i.e. non-CNS) tumor
• Adequate distance to optic nerve(s), chiasm and brainstem (organs at risk for radiotherapy)
• Adequate birth control

You may not qualify if:

• Leptomeningeal spread and dural attachment (assessed pre- and intraoperatively)
• Frozen section reveals primary CNS tumor, lymphoma, SCLC (Small-cell lung cancer) or germinoma
• More than one brain metastasis
• Psychiatric or social condition potentially interfering with compliance
• Contraindication against anesthesia, surgery, MRI and/or contrast agents
• Pregnant or breast-feeding women

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Hospital del Mar

Barcelona, 08003, Spain

RECRUITING

Related Publications (4)

• Giordano FA, Brehmer S, Murle B, Welzel G, Sperk E, Keller A, Abo-Madyan Y, Scherzinger E, Clausen S, Schneider F, Herskind C, Glas M, Seiz-Rosenhagen M, Groden C, Hanggi D, Schmiedek P, Emami B, Souhami L, Petrecca K, Wenz F. Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma (INTRAGO): An Open-Label, Dose-Escalation Phase I/II Trial. Neurosurgery. 2019 Jan 1;84(1):41-49. doi: 10.1093/neuros/nyy018.

  PMID: 29528443 RESULT

• Weil RJ, Mavinkurve GG, Chao ST, Vogelbaum MA, Suh JH, Kolar M, Toms SA. Intraoperative radiotherapy to treat newly diagnosed solitary brain metastasis: initial experience and long-term outcomes. J Neurosurg. 2015 Apr;122(4):825-32. doi: 10.3171/2014.11.JNS1449. Epub 2015 Jan 23.

  PMID: 25614945 RESULT

• Cifarelli CP, Brehmer S, Vargo JA, Hack JD, Kahl KH, Sarria-Vargas G, Giordano FA. Intraoperative radiotherapy (IORT) for surgically resected brain metastases: outcome analysis of an international cooperative study. J Neurooncol. 2019 Nov;145(2):391-397. doi: 10.1007/s11060-019-03309-6. Epub 2019 Oct 25.

  PMID: 31654248 RESULT

• Vargo JA, Sparks KM, Singh R, Jacobson GM, Hack JD, Cifarelli CP. Feasibility of dose escalation using intraoperative radiotherapy following resection of large brain metastases compared to post-operative stereotactic radiosurgery. J Neurooncol. 2018 Nov;140(2):413-420. doi: 10.1007/s11060-018-2968-4. Epub 2018 Aug 9.

  PMID: 30094718 RESULT

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

Central Study Contacts

Palmira Foro, MD, PhD

CONTACT

628118443; pforo@psmar.cat

Palmira Foro, MD,PhD

CONTACT

628118443; pforo@psmar.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 19, 2021
• Study Start: May 5, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 6, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)