NASRS
A Study of Neoadjuvant Stereotactic Radiosurgery for Large Brain Metastases
Rekrutierend
NCT-Nummer:
NCT03368625
Studienbeginn:
März 2018
Letztes Update:
11.10.2023
Wirkstoff:
-
Indikation (Clinical Trials):
Neoplasm Metastasis, Brain Neoplasms
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
University Health Network, Toronto
Collaborator:
-
Studienleiter
David Shultz, MD
Principal Investigator
University Health Network, Toronto
Kontakt
David Shultz, M.D.
Kontakt:
Phone: 416-946-4501
Phone (ext.): 6899
E-Mail: david.shultz@rmp.uhn.ca» Kontaktdaten anzeigen
Detailed Description:
Recently, a novel treatment strategy for large brain metastases was described whereby lesions
appropriate for resection were treated with a single fraction of SRS pre-operatively. In a
retrospective analysis, of 51 lesions with a median tumor size of 3 cm, 1-year LC was 86%.
This neoadjuvant approach resulted in lower rates of leptomeningeal failure (3 vs. 17%) and
symptomatic radiation toxicity (1.5 vs. 14.6 %) compared to a comparative cohort of lesions
treated with post-operative cavity boost SRS (POCBS).
Based on promising results, we believe that a prospective trial to establish the value of
neoadjuvant SRS (NaSRS) for the treatment of BM appropriate for resection is warranted.
This study will be a non-randomized phase II trial for patients with one to six brain
metastases, at least one of which is appropriate for surgical resection. Upon registration,
patients will be assigned to receive neo-adjuvant stereotactic radiosurgery (NASRS).
Inclusion Criteria:
- Lymphoma, small cell carcinoma, and seminoma are excluded
- A lesion appropriate for resection, not previously treated with SRS. Lesions should be
> 2 cm and < 4 cm in largest dimension, and require resection ( e.g. due to mass
effect or to obtain a tissue diagnosis). Index lesions will be treated with SRS and
surgery, as outlined in the treatment section of the protocol.
- Seen by a neurosurgeon or radiation oncologist and judged to be appropriate for
participation in this study, including the ability to tolerate NaSRS, e.g., the
ability to lie flat in a stereotactic head frame.
- Any unresected lesions or lesions for which there is no planned immediate resection
(non index lesions) must measure < 3.0 cm in maximal extent on the contrasted MRI or
CT brain scan obtained ≤ 35 days prior to pre-registration. Unresected lesions will be
treated with SRS as outlined in the treatment section of the protocol. .
- ECOG ≤ 2
- MRI confirmed 1-6 lesions, one of which is the index lesion. Each non-index lesion (up
to 5) must measure ≤ 3.0 cm in maximal extent on contrasted MRI scan, and not
otherwise require resection.
Note: The pre-registration MRI may be obtained ≤ 35 days prior to enrolment.
Exclusion Criteria:
- Treatment plan respecting normal tissue tolerances using dose fractionation specified
within the protocol cannot be achieved.
- pregnancy
- Prior cranial radiotherapy targeting the index lesion, or any prior WBRT.
- Inability to complete a MRI with contrast of the head, or a known allergy to
gadolinium.
- Cytotoxic Chemotherapy within 7 days prior to SRS (molecularly targeted therapies ,
including immune-modulatory drugs, can be given within seven days of SRS at the
discretion of the treating physician)
- Metastatic germ cell tumor, small cell carcinoma, or lymphoma or any primary brain
tumor
- Imaging Findings:
- Widespread definitive leptomeningeal metastasis.
- A brain metastasis that is located ≤ 2 mm of the optic chiasm
- Evidence of midline shift
- Fourth ventricular narrowing, concerning for hydrocephalus
Primary outcome:
1. Radiation toxicity (Time Frame - 1 year):
The rate at 1 year of symptomatic (≥grade 2) radiation toxicity
Secondary outcome:
1. local control (Time Frame - 1 year):
1-year local control (PR+CR) of the index lesion resulting from NaSRS
2. leptomeningeal disease (Time Frame - 1 year):
1-year rates of leptomeningeal disease
3. Survival (Time Frame - 5 years):
Median survival
4. progression-free survival (Time Frame - 2 years)
5. overall survival (Time Frame - 2 years)
- Stereotactic Radiosurgery:
Stereotactic Radiosurgery before surgical resection of brain mets.
Quelle: ClinicalTrials.gov
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