Intracavitary Carrier-embedded Cs131 Brachytherapy for Recurrent Brain Metastases: a Randomized Phase II Study

Conditions

Recurrent Brain Metastases

Keywords

Cs-131 Brachytherapy, Brain Metastasis, 20-542

Brief summary

The purpose of this study is to see if Cs-131 brachytherapy is effective in people with recurrent brain cancer who are scheduled to have brain surgery for removal of their tumor(s). The researchers would like to see whether Cs-131 prevents brain tumors from growing back after surgery.The researchers will compare Cs-131 brachytherapy (which occurs during brain surgery) with the usual approach of brain surgery without brachytherapy. The researchers will compare both the effectiveness and safety of the two approaches.

Irini Yacoub, Robert J. Young, Anne S. Reiner, Alexandra Gantini-Larsen, Yoshiya Yamada et al. (14 authors)

Neuro-Oncology2024-11-01

10.1093/neuonc/noae165.1132

SURG-10. PERMANENT CARRIER-EMBEDDED CESIUM-131 BRACHYTHERAPY FOR THE SALVAGE TREATMENT OF PREVIOUSLY IRRADIATED, RECURRENT BRAIN METASTASES

Brandon S. Imber, Kathryn Beal, Anne S. Reiner, Alexandra Giantini-Larsen, Jonathan Yang et al. (11 authors)

Neuro-Oncology2022-11-01

10.1093/neuonc/noac209.976

LOCL-15 PERMANENT CARRIER-EMBEDDED CESIUM-131 BRACHYTHERAPY FOR THE SALVAGE TREATMENT OF PREVIOUSLY IRRADIATED, RECURRENT BRAIN METASTASES

Brandon S. Imber, Kathryn Beal, Anne S. Reiner, Alexandra Giantini-Larsen, Jonathan T. Yang et al. (11 authors)

Neuro-Oncology Advances2022-08-01

10.1093/noajnl/vdac078.057

Dosimetric Impacts of Source Migration, Radioisotope Type, and Decay with Permanent Implantable Collagen Tile Brachytherapy for Brain Tumors

Dilini Pinnaduwage, Shiv P. Srivastava, Xiangsheng Yan, Shyam Jani, David Brachman et al. (6 authors)

Technology in Cancer Research & Treatment2022-01-0111 citations

10.1177/15330338221106852

TRLS-07. Intracavitary carrier-embedded Cs131 brachytherapy for recurrent brain metastases: A randomized phase II study

Nelson S. Moss, Brandon S. Imber, Gil’ad N. Cohen, Kavya Prasad, David Aramburu Núñez et al. (8 authors)

Neuro-Oncology Advances2021-08-015 citations

10.1093/noajnl/vdab071.025

Interventions

PROCEDURECraniotomy

Craniotomy

RADIATIONCesium-131 brachytherapy

Intracavitary Cesium-131 brachytherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Masking description

Patient will be blinded to their treatment until postoperatively.

Intervention model description

Prospective randomized phase II multicenter trial.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Adult patients ≥ 18 years of age who are capable of giving consent * Undergoing elective craniotomy for resection of a previously-irradiated brain metastasis with suspicion for viable disease at the time of consent, and anticipated achievement of gross-total or near-total (\>/=95%) resection * Karnofsky Performance Status score (KPS) of ≥70 * Ability to undergo brain MRI with gadolinium

Exclusion criteria

* Unable to tolerate MRI or CT imaging * Pregnancy (patients must have a negative pregnancy test within 30 days of the operation) * Women must agree to not breastfeed for at least 12 weeks after the procedure (lactating and discarding in that interval allowable) * Diagnosis of leptomeningeal carcinomatosis or \>5 additional active or untreated CNS lesions for a total of \>6 active lesions * Prior irradiation (EQD2) in excess of 100 Gy to site of implant, using an α/β of 2 * Apposition of tumor margin to brainstem or optic apparatus * Previous infection within the operative field, current active systemic infection requiring systemic therapy, or immunodeficiency * Urgent surgery required prior to availability of brachytherapy Intraoperative Exclusion Criterion: * Patients will be excluded if intraoperative pathology is not consistent with \>/=5% viable metastatic disease.

Design outcomes

Primary

Measure	Time frame	Description
freedom from local progression	9 months following surgery	With a contrast enhanced brain MRI scan. Treatment response will be determined based on the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria.

Secondary

Measure	Time frame	Description
wound complications	3 months	Physical examination including wound examination will be performed, and wound complications (including dehiscence, superficial/deep infection, CSF leak) will be recorded by the evaluating clinicians.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORNelson Moss, MD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed