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

ABSTRACT: Abstract

Background

The salvage treatment of recurrent brain metastases after failed irradiation is a clinical challenge. Adjuvant SRS is standard of care for resected brain metastases in the upfront post-resection setting given a significant local control advantage over surgery alone. However, the role of reirradiation following salvage resection of recurrent post-irradiation metastases is unclear owing to both reduced efficacy of subsequent courses of external beam radiation, and likely increased risk of radiation injury. Intracavitary cesium 131 (Cs131) brachytherapy offers a highly conformal adjunct radiation option that we hypothesize may allow for improved local control while also theoretically conveying a low risk of radiation necrosis. In this randomized controlled study, we aim to define the potential benefits and risks of resection plus permanently implanted, carrier-embedded intracavitary Cs131 brachytherapy versus conventional care (surgery alone).

Methods

This is a single-center randomized controlled study of patients undergoing resection of recurrent, previously-irradiated brain metastases. Exclusion criteria include prior in-field infection, prior radiation >100Gy (in 2Gy fraction equivalents), >5 additional active or untreated CNS lesions, or leptomeningeal carcinomatosis. Subjects are randomized 1:1 to undergo either surgery with placement of Cs131 brachytherapy or surgery alone. The primary endpoint is freedom from treated-site progression at 9 months. Secondary endpoints include wound complications at 3 months and time to local retreatment at the index site, and exploratory objectives include neurocognitive function prior to surgery and at 3 and 12 months postoperatively, with correlative analyses of the previously irradiated brain metastasis tissue. Accrual began on December 24, 2020 and 5 of a planned 76 patients have enrolled. This is the first randomized controlled trial of surgery plus permanently implanted intracavitary Cs131 brachytherapy versus surgery alone for recurrent brain metastases. ClinicalTrials.gov Identifier: NCT04690348

SUBMITTER: Moss N

PROVIDER: S-EPMC8351308 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Abstract BACKGROUND Salvage of recurrent of previously-irradiated brain metastases (rBrM) is a significant clinical challenge. High local failure rates are seen following salvage resection without adjuvant re-irradiation, while reirradiation is associated with high radionecrosis rates. Salvage surgery plus intraoperative Cs131 brachytherapy may offer dosimetric and biologic advantages including improved local control versus observation, with reduced integral brain dose versus re-irradiation. METHODS A prospective registry of consecutively treated patients with rBrM after prior stereotactic radiosurgery (SRS) was analyzed. Following maximal-safe resection and intraoperative viable-disease confirmation, cavities were implanted with commercially-available, collagen-matrix embedded Cs131 seeds (GammaTile, GT Medical Technologies). Prescribed dose was 60Gy at 5mm from the cavity. RESULTS Twenty patients underwent 24 operations with Cs131 implantation in 25 cavities. Previous SRS occurred a median of 358d preoperatively (range=56-1334). Median maximum preoperative diameter was 3.0cm (range=1.1-6.3) and enhancing volume was 9.5cm3 (range=0.6-69.7). Gross- or near-total resection was achieved in 60% of lesions. A median of 16 Cs131 seeds (range=6-30), with a median activity of 3.5U/seed were implanted. Maximal preoperative diameter and enhancing volume were weakly associated with the number of implanted seeds (correlation coefficients=0.50, 0.41, respectively). There was one postoperative wound dehiscence in a multiply resected and irradiated patient with hydrocephalus. With median follow-up of 12.5 months, 2 tumors recurred (one in-field, one marginal) resulting in a 1-year progression incidence of 9.8% (95%CI=0.0-23.2). Radiographic seed migration was identified in 7/25 cavities (28%) on surveillance scans ranging from 1.9-11.7 months post-implantation, without clinical sequelae. CONCLUSIONS With >1 year of follow-up, intraoperative brachytherapy with commercially-available Cs131 implants was associated with a high rate of local control and a favorable toxicity profile. Modest correlation between preoperative tumor geometry and implanted tiles in the context of high associated cost suggests a need to optimize planning criteria. A randomized trial of salvage resection with or without Cs131 is ongoing (NCT04690348) to assess the incremental benefit of brachytherapy.

Project description:BackgroundTo assess the intra-fractional dosimetric variations of image-guided brachytherapy of cervical cancer.MethodsA total of 38 fractions (9 patients) undergoing brachytherapy for cervical cancer underwent a CT scanning for treatment planning (planning CT) and a Cone-beam CT (CBCT) scanning immediately prior to delivery (pre-delivery CBCT). The variations of volumes as well as the dosimetric impact from treatment planning to delivery (intra-application) were evaluated. The dose volume histogram parameters including volume, D90 of high-risk clinical target volume (HRCTV) and D2cc of organs at risk (OARs) were recorded.ResultsThe relative differences (mean ± 1SD) of the volume and D90 HRCTV across the two scans were - 2.0 ± 3.3% and - 1.2 ± 4.5%, respectively. The variations of D2cc for bladder, rectum, sigmoid and small intestine are - 0.6 ± 17.1%, 9.3 ± 14.6%, 7.2% ± 20.5% and 1.5 ± 12.6%, respectively. Most of them are statistically nonsignificant except the D2cc for rectum, which showed a significant increase (P = 0.001). Using 5% and 10% uncertainty of physical dose for HRCTV at a 6 Gy × 5 high-dose-rate schedule, the possibility of total equivalent doses in 2 Gy fractions (EQD2) lower than 85 Gy is close to 0% and 3%, respectively. Performing similar simulation at 15% and 20% uncertainty of a 4 Gy physical dose for OARs, the possibility of total EQD2 dose exceeding 75 Gy is about 70%. Less than 1% of the total EQD2 of OARs would exceed 80 Gy.ConclusionsAverage intra-fractional dosimetric variation of HRCTV was small in an interval of less than 1 h, and the possibility of total EQD2 exceeding 85 Gy is higher than 97%. The intra-fractional dosimetric variations of OARs might result in an overdose for OARs in a single fraction or the whole treatment. It is necessary to detect unfavorable anatomical changes by re-imaging and take interventions to minimize applied doses and reduce the risk of complications.

Project description:BACKGROUND:The objective of focal brachytherapy (BT) is to provide effective prostate cancer control for low-risk disease but with reduced genitourinary, gastrointestinal and sexual side effects in a cost-effective way. OBJECTIVE:The aim of this study is to describe a phase II study examining technical and dosimetric feasibility and toxicity, quality of life changes, and local control with post-treatment biopsy outcomes in men with early stage low volume prostate cancer treated with focal iodine-125 seed BT. METHODS:The study design is a prospective, multicenter trial with a planned sample size of 20 patients including men with a minimum age of 60 years, a life expectancy estimated to be greater than 10 years, with low or low-tier intermediate risk prostate cancer, unilateral disease on the biopsy, and a Gleason score of ?3+4 and <25% cores involved. The investigations specific for the study are multi-parametric magnetic resonance imaging (Mp-MRI) baseline, at 20 and 36 months to rule out high grade disease and a transperineal mapping biopsy (baseline and at 36 months) for more accurate patient selection. The hemigland region will receive 144 Gy. Standard normal tissue constraints will be considered as for a whole gland (WG) implant. Dosimetric parameters will be evaluated at day 30 after the implant. Toxicity and quality of life will be evaluated with international validated questionnaires focusing on urinary, rectal, sexual domain, and general health-related quality of life. The patients will complete this assessment at baseline and then approximately every 6 months after the implant up to 10 years. RESULTS:To date, one patient is involved in the trial. He underwent the pre-implant investigations which found bilateral disease. Therefore, a standard seed implant was performed. If the results from this trial provide evidence that the treatment is safe, feasible, and improves toxicity, funding will be sought to conduct a large, multicenter, randomized controlled trial (RCT). CONCLUSIONS:This protocol is designed to show feasibility in delivering hemigland focal therapy with seed BT. It may answer crucial questions and obtain data which will enable downstream decisions on focal low dose rate (LDR) prostate BT. CLINICALTRIAL:Clinicaltrial.gov NCT02643511; https://www.clinicaltrials.gov/ct2/show/NCT02643511 (Archived by Webcite at http://www.webcitation.org/6ghLCzIhY).

Project description:To investigate the dosimetric impact of the heterogeneity dose calculation Acuros (Transpire Inc., Gig Harbor, WA), a grid-based Boltzmann equation solver (GBBS), for brachytherapy in a cohort of cervical cancer patients.The impact of heterogeneities was retrospectively assessed in treatment plans for 26 patients who had previously received (192)Ir intracavitary brachytherapy for cervical cancer with computed tomography (CT)/magnetic resonance-compatible tandems and unshielded colpostats. The GBBS models sources, patient boundaries, applicators, and tissue heterogeneities. Multiple GBBS calculations were performed with and without solid model applicator, with and without overriding the patient contour to 1 g/cm(3) muscle, and with and without overriding contrast materials to muscle or 2.25 g/cm(3) bone. Impact of source and boundary modeling, applicator, tissue heterogeneities, and sensitivity of CT-to-material mapping of contrast were derived from the multiple calculations. American Association of Physicists in Medicine Task Group 43 (TG-43) guidelines and the GBBS were compared for the following clinical dosimetric parameters: Manchester points A and B, International Commission on Radiation Units and Measurements (ICRU) report 38 rectal and bladder points, three and nine o'clock, and (D2cm3) to the bladder, rectum, and sigmoid.Points A and B, D(2) cm(3) bladder, ICRU bladder, and three and nine o'clock were within 5% of TG-43 for all GBBS calculations. The source and boundary and applicator account for most of the differences between the GBBS and TG-43 guidelines. The D(2cm3) rectum (n = 3), D(2cm3) sigmoid (n = 1), and ICRU rectum (n = 6) had differences of >5% from TG-43 for the worst case incorrect mapping of contrast to bone. Clinical dosimetric parameters were within 5% of TG-43 when rectal and balloon contrast were mapped to bone and radiopaque packing was not overridden.The GBBS has minimal impact on clinical parameters for this cohort of patients with unshielded applicators. The incorrect mapping of rectal and balloon contrast does not have a significant impact on clinical parameters. Rectal parameters may be sensitive to the mapping of radiopaque packing.

Dataset Information

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

Background

Methods

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