Brain Metastases Clinical Trial
Official title:
Intraoperative Radiotherapy in Patients With Brain Metastases
Verified date | March 2023 |
Source | Parc de Salut Mar |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 25 |
Est. completion date | March 1, 2024 |
Est. primary completion date | March 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital del Mar | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Parc de Salut Mar |
Spain,
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. — View Citation
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 — View Citation
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;1 — View Citation
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.J — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Primary | 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 | Median regional PFS (rPFS) | To any progression outside of the 0.5 cm margin around the resection cavity, assessed by serial MRI scans and RANO response assessment in neuro-oncology . | 6 months from the date of surgery | |
Secondary | Global PFS (gPFS) | The time (in months) from surgery to any intra- and extracranial tumor progress | 6 months from the date of surgery | |
Secondary | Median overall survival (OS) | The time (in months) from surgery of brain metastases to death from by any cause. | 6 months from the date of surgery |
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