Trial of Preoperative Radiosurgery Versus Postoperative Stereotactic Radiotherapy for Resectable Brain Metastases (PREOP-2)
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ClinicalTrials.gov Identifier: NCT05124236 |
Recruitment Status :
Recruiting
First Posted : November 17, 2021
Last Update Posted : September 10, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Brain Metastases, Adult | Radiation: preoperative radiosurgery Radiation: postoperative hypofractionated stereotactic radiotherapy | Not Applicable |
Neurosurgical resection of a brain metastasis in patients with a diagnosis of cancer may be indicated however the recurrence rate approximates 50% and adjuvant radiotherapy is standard. Single fraction postoperative stereotactic radiosurgery (SRS) has been widely adopted as a standard therapy as it achieves equivalent survival and prevents loss of neurocognitive function as compared with whole brain radiotherapy and improves cavity local control rates as compared with observation. Hypofractionated stereotactic radiotherapy in 3 to 5 fractions (hfSRT) is also used in the postoperative setting.
Nodular leptomeningeal disease (nLMD) is a recognised pattern of failure after postoperative SRS and hfSRT. A 16.9% incidence of nodular LMD was seen after surgery and a similar incidence of 11%-28%is reported following postoperative SRS in retrospective series. These data suggest that postoperative SRS/hfSRT have no significant effect on the development of LMD following surgery.
The incidence of LMD following single fraction preoperative SRS is only 6.1% according to the largest retrospective series. Preoperative SRS takes advantage of the easier delineation of an intact BM and sterilizes tumor cells disseminated at surgery. Side effects are minimized by a smaller planning margin, a dose reduction and resection of the irradiated volume. In addition, there is no delay to systemic therapy due to wound healing/complications. Furthermore, a single fraction offers patient convenience.
This trial will randomise and compare intracranial outcomes between single fraction preoperative SRS and 5 fraction postoperative hFSRT.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter Prospective, Interventional, Randomized Trial of Preoperative Radiosurgery Compared With Postoperative Stereotactic Radiotherapy for Resectable Brain Metastases |
Actual Study Start Date : | July 29, 2022 |
Estimated Primary Completion Date : | December 30, 2025 |
Estimated Study Completion Date : | December 30, 2025 |
Arm | Intervention/treatment |
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Experimental: Preoperative radiosurgery
The interventional arm is single fraction preoperative radiosurgery to a brain metastasis identified for neurosurgical resection.
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Radiation: preoperative radiosurgery
single fraction radiosurgery |
Active Comparator: Postoperative hypofractionated stereotactic radiotherapy
The active comparator arm is the standard of care of postoperative hypofractionated stereotactic radiotherapy to the surgical cavity in 5 fractions following resection of the brain metastasis.
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Radiation: postoperative hypofractionated stereotactic radiotherapy
5 fraction stereotactic radiotherapy /fractionated radiosurgery |
- Leptomeningeal disease [ Time Frame: 12 months after intervention ]Incidence (%)
- Local control of the surgical cavity [ Time Frame: 12 months after intervention ]No evidence of tumour recurrence on contrsat-enhanced MRI
- Distant brain failure [ Time Frame: 12 months after intervention ]New brain metastases
- Radionecrosis [ Time Frame: 12 months after intervention ]Adverse radiation effects
- Quality of life assessment [ Time Frame: 3,6,12 months after intervention ]EORTC questionnaire core questionnaire QLQ30, EORTC questionnaire brain module BN 20 (1-4, low scores reflect better QoL)
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Age ≥18
- Karnofsky performance status ≥60
- Histological diagnosis of a malignant primary or metastatic tumour
- Ability to take steroids
- No contraindication to magnetic resonance imaging (MRI)
- MRI-diagnosis of a clearly demarcated contrast-enhancing brain metastasis up to 4.0 cm diameter indicated for neurosurgical resection (tumorboard decision). Up to 3 other brain metastases suitable for primary radiosurgery/ stereotactic radiotherapy
- Survival estimated by primary clinician > 12 months
- Platelet count > 100/ml, INR < 1.3, Hb > 7.5 g/dL
Exclusion Criteria:
- Radiosensitive histology: germ cell tumour, lymphoma, multiple myeloma
- >10 mm midline shift, effacement of the 4th ventricle or other sign of raised intracranial pressure requiring urgent decompressive surgery
- More than 4 brain metastases or the diameter of the metastasis for resection >4.0 cm.
- More than 1 metastasis requiring resection
- Leptomeningeal disease in the CSF or on MRI (unless localized and can be irradiated then resected with the metastasis)
- Prior radiation to the brain (SRS/SRT to lesion to be resected and /or WBRT)
- Prior resection of a primary or secondary brain tumor
- Prior diagnosis of a non-meningioma brain tumor
- Prior radionuclide therapy within 30 days
- Prior anti-VEGF therapy within 6 weeks
- Unable to tolerate radiosurgery immobilization and treatment
- Inability to give informed consent
- Pregnancy or lactation
- Females of reproductive potential not willing to use effective contraception for at least 6 months after radiotherapy
- Males of reproductive potential not effective contraception for 3 months after radiotherapy
- Lack of likely compliance with protocol and follow-up
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05124236
Contact: Susanne Rogers, MD PhD | +41 62 838 5726 | Susanne.rogers@ksa.ch | |
Contact: Oliver Riesterer, Prof. | +41 62 838 4249 | oliver.riesterer@ksa.ch |
Switzerland | |
Kantonsspital Aarau | Recruiting |
Aarau, Aargau, Switzerland, 5001 | |
Contact: Susanne J Rogers, MD PhD 0041628385726 susanne.rogers@ksa.ch | |
Contact: Sonja Schwenne 0041628386259 sonja.schwenne@ksa.ch | |
Inselspital, Universitätsklinik für Radio-Onkologie | Recruiting |
Bern, Freiburgstrasse, Switzerland, 3010 | |
Contact: Ekin Ermis, Dr. med. +41 31 632 26 32 erkin.ermis@insel.ch | |
Kantonsspital Graubünden | Recruiting |
Chur, Switzerland, 7000 | |
Contact: Brigitta Baumert, Dr. med. +41 81 256 64 90 rigitta.baumert@ksgr.ch | |
Luzerner Kantonsspital | Recruiting |
Luzern, Switzerland, 6000 | |
Contact: Gabriela Studer, Prof. Dr. med. +41 205 58 01 gabriela.studer@luks.ch | |
Kantonsspital St. Gallen | Recruiting |
St. Gallen, Switzerland, 9000 | |
Contact: Guido Henke, Dr. med. +41 71 494 2192 guido.henke@kssg.ch | |
Kantonsspital Winterthur | Recruiting |
Winterthur, Switzerland, 8400 | |
Contact: Christoph Oehler, PD Dr. med. +41 52 266 26 58 christoph.oehler@ksw.ch |
Principal Investigator: | Susanne Rogers, MD PhD | Kantonsspital Aarau, Zentrum für Radio-Onkologie KSA-KSB |
Responsible Party: | Susanne Rogers, Sponsor-Investigator, Kantonsspital Aarau |
ClinicalTrials.gov Identifier: | NCT05124236 |
Other Study ID Numbers: |
410.000.146 |
First Posted: | November 17, 2021 Key Record Dates |
Last Update Posted: | September 10, 2022 |
Last Verified: | September 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Neoplasm Metastasis Brain Neoplasms Neoplastic Processes Neoplasms Pathologic Processes Central Nervous System Neoplasms |
Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases |