scholarly journals Resection and Surgically Targeted Radiation Therapy for the Treatment of Larger Recurrent or Newly Diagnosed Brain Metastasis: Results From a Prospective Trial

Cureus ◽  
2020 ◽  
Author(s):  
Peter Nakaji ◽  
Kris Smith ◽  
Emad Youssef ◽  
Theresa Thomas ◽  
Dilini Pinnaduwage ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Brain Metastasis ◽  
Prospective Trial ◽  
Newly Diagnosed ◽  
Targeted Radiation Therapy

scholarly journals CTNI-58. A PROSPECTIVE TRIAL OF RESECTION AND SURGICALLY TARGETED RADIATION THERAPY FOR INITIAL OR SALVAGE TREATMENT OF AGGRESSIVE MENINGIOMA

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii56-ii56
Author(s):  
Leland Rogers ◽  
Peter Nakaji ◽  
Emad Youssef ◽  
Kris Smith ◽  
Terry Thomas ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Prospective Trial ◽  
Local Therapy ◽  
Newly Diagnosed ◽  
Who Grade ◽  
Tumor Bed ◽  
Prior Therapy ◽  
Grade Ii ◽  
Favorable Safety ◽  
Targeted Radiation Therapy

Abstract INTRODUCTION Achieving durable local control (LC) for aggressive or recurrent meningiomas remains problematic. Resection (R) alone is insufficient and even with the addition of radiation therapy (RT), outcomes are suboptimal in many series. OBJECTIVE Hypothesizing R plus Surgically Targeted Radiation Therapy (STaRT) may improve LC, we evaluated a permanently implanted brachytherapy device consisting of Cs-131 seeds positioned within modular resorbable collagen carrier/spacer tiles (GammaTile, GT Medical Technologies, Tempe AZ). METHODS From 2/2013-2/2018 recurrent and newly diagnosed aggressive meningiomas were treated on a prospective single-arm study (NCT#03088579). At completion of maximum safe resection the tumor bed was lined with collagen tiles imbedded with Cs-131, delivering 60–80 Gy at 5 mm depth. No additional local therapy was given absent progression. RESULTS 35 meningiomas in 28 patients were treated; 29 recurrent (22 prior R+RT, 6 R only, and 1 RT only) and 6 without prior therapy. WHO grade was I in 2 patients, II in 28, and III in 5. Median age was 66 years (range 37–82), KPS 80 (70–100), female: male ratio 15:13. Mean time for implantation was 5 minutes. At a median radiographic follow-up of 25.5 months (range 0.1–71) LC was 80% (28/35) and median time to progression had not been reached (95% CI > 35.6 months). LC at 12/24/36/48 months was 100/89/72/72% for all tumors, 100/93/79/79% for Grade II, and 100/50/0/0% for Grade III, respectively. No patient receiving STaRT as their initial RT failed. Median overall survival was 50 months. Four symptomatic adverse events occurred, 2 wound breakdowns requiring surgery and 2 radiation-related brain changes, medically treated. CONCLUSION R+STaRT demonstrates favorable safety and LC outcomes in this single-arm prospective trial that includes heavily pre-treated patients. A commercial version of the device recently received FDA clearance for use in newly diagnosed malignant or recurrent intracranial neoplasms including meningiomas.

A phase III multicenter randomized controlled trial of postsurgical stereotactic radiotherapy versus surgically targeted radiation therapy (STaRT) for the treatment of large (>2.5cm) newly diagnosed brain metastases: Trial in progress.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. TPS2067-TPS2067
Author(s):  
Jeffrey Weinberg ◽  
Mary Frances McAleer ◽  
Jason Michael Johnson ◽  
Rajat Kudchadker ◽  
Jeffrey Scott Wefel ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Brain Metastases ◽  
Verbal Learning ◽  
Phase Iii ◽  
External Beam Radiation ◽  
Secondary Outcome ◽  
Recurrence Free Survival ◽  
Newly Diagnosed ◽  
Free Survival ◽  
Targeted Radiation Therapy

TPS2067 Background: Resection (R) followed by single or multi-fraction stereotactic radiosurgery (SRT) of brain metastases lowers resection bed recurrence compared to R alone. Nevertheless, for larger (>2.5cm) brain metastasis, 12-month recurrence rates after R+SRT can exceed 20–30%. Aiming to improve outcomes, a permanently implanted collagen tile brachytherapy device (GammaTile or GT, GT Medical Technologies, Tempe, AZ) utilizing Cs-131 seeds embedded within a bioresorbable collagen tile was developed and is described as Surgically Targeted Radiation Therapy (STaRT) to distinguish it from external beam radiation therapy. It is hypothesized that immediate adjuvant radiotherapy (RT) and/or RT dose intensification could improve outcomes. The device is FDA-cleared for this indication and early commercial use is demonstrating favorable safety and efficacy outcomes. STaRT allows rapid dose delivery of radiation therapy directly to the tumor bed with predictable dosimetry immediately at the time of resection, and an intense but localized radiation treatment, which may confer a reduced risk for radiation necrosis compared to other therapies. The device is easily placed with minimal additional operative time and limited staff radiation exposure. It is hypothesized that R+ STaRT will increase the surgical bed recurrence-free survival, while reducing the impact on functional and neurocognitive status compared to R+SRT. Methods: Multicenter, randomized, comparison trial of patients with resectable, previously untreated “index” brain metastases measuring ≥2.5–5 cm, and 0–3 other tumors, will be preoperatively randomized 1:1 to undergo either R+ SRT or R+STaRT to the index lesion; unresected tumors in both groups will receive SRT. Planned sample size is 180 from 13 sites. Enrollment will open in Q1. Primary endpoint is surgical bed-recurrence free survival. Secondary endpoints include overall survival, quality of life (Functional Assessment of Cancer Therapy-Brain, Linear Analog Self-Assessment), neurocognition (Hopkins Verbal Learning Test, Trail Making Tests, Controlled Oral Word Association), functional status (Karnofsky Performance Scale, Barthel-ADL), and adverse events. Follow-up will be at 1,3,6,9, and 12 months, then every 6 months through 24 months. This will be the first randomized trial comparing R+SRT versus R+STaRT delivered by Cs-131 sources in permanently implanted resorbable collagen tile carriers. Primary and secondary outcome measures will be captured to elucidate the potential risks and benefits of these two differing post-operative RT delivery methods in the setting of newly diagnosed metastatic brain tumors. Clinical trial information: NCT04365374.

Neurocognitive function and quality of life in patients with newly diagnosed brain metastasis after treatment with intra-operative cesium-131 brachytherapy: a prospective trial

2015 ◽  
Vol 127 (1) ◽  
pp. 63-71 ◽  
Author(s):  
Anthony Pham ◽  
Menachem Z. Yondorf ◽  
Bhupesh Parashar ◽  
Ronald. J. Scheff ◽  
Susan C. Pannullo ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Brain Metastasis ◽  
Prospective Trial ◽  
Neurocognitive Function ◽  
Newly Diagnosed

scholarly journals Pulsed radiation therapy for the treatment of newly diagnosed glioblastoma

2020 ◽  
Author(s):  
Muayad F Almahariq ◽  
Thomas J Quinn ◽  
Jessica D Arden ◽  
P T Roskos ◽  
George D Wilson ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Verbal Learning ◽  
Prospective Trial ◽  
Progression Free Survival ◽  
Neurocognitive Function ◽  
Tumor Control ◽  
Subtotal Resection ◽  
Newly Diagnosed ◽  
Clinical Series ◽  
Newly Diagnosed Glioblastoma

Abstract Background Pulsed radiation therapy (PRT) has shown effective tumor control and superior normal-tissue sparing ability compared with standard radiotherapy (SRT) in preclinical models and retrospective clinical series. This is the first prospective trial to investigate PRT in the treatment of patients with newly diagnosed glioblastoma (GBM). Methods This is a single-arm, prospective study. Patients with newly diagnosed GBM underwent surgery, followed by 60 Gy of PRT with concurrent temozolomide (TMZ). Each day, a 2-Gy fraction was divided into ten 0.2-Gy pulses, separated by 3-minute intervals. Patients received maintenance TMZ. Neurocognitive function (NCF) and quality of life (QoL) were monitored for 2 years using the Hopkins Verbal Learning Test‒Revised and the European Organisation for Research and Treatment of Cancer QLQ-C30 QoL questionnaire. Change in NCF was evaluated based on a minimal clinically important difference (MCID) threshold of 0.5 standard deviation. Results Twenty patients were enrolled with a median follow-up of 21 months. Median age was 60 years. Forty percent underwent subtotal resection, and 60% underwent gross total resection. One patient had an isocitrate dehydrogenase (IDH)–mutated tumor. Median progression-free survival (PFS) and overall survival (OS) were 10.7 and 20.9 months, respectively. In a post-hoc comparison, median OS for the prospective cohort was longer, compared with a matched cohort receiving SRT (20.9 vs 14 mo, P = 0.042). There was no decline in QoL, and changes in NCF scores did not meet the threshold of an MCID. Conclusions Treatment of newly diagnosed GBM with PRT is feasible and produces promising effectiveness while maintaining neurocognitive function and QoL. Validation of our results in a larger prospective trial warrants consideration.

scholarly journals Clinical Trials in Progress: ROADS Trial

ONCOLOGY ◽  
2021 ◽  
pp. 495-495
Author(s):  
Jeffrey Weinberg
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trial ◽  
Radiation Therapy ◽  
Brain Tumors ◽  
Controlled Trial ◽  
Newly Diagnosed ◽  
Metastatic Brain Tumors ◽  
Phase 3 ◽  
Randomized Controlled ◽  
Targeted Radiation Therapy

Phase 3 Randomized Controlled Trial of Post-Surgical Stereotactic Radiotherapy (SRT) versus Surgically Targeted Radiation Therapy (STaRT) with GammaTile for Treatment of Newly Diagnosed Metastatic Brain Tumors (ROADS; NCT04365374).

RTID-01. PHASE III MULTICENTER RCT OF POST-SURGICAL STEREOTACTIC RADIOTHERAPY VERSUS SURGICALLY TARGETED RADIATION THERAPY FOR THE TREATMENT OF LARGE NEWLY DIAGNOSED BRAIN METASTASES – TRIAL IN PROGRESS

2021 ◽  
Vol 23 (Supplement_6) ◽  
pp. vi193-vi193
Author(s):  
Jeffrey Weinberg ◽  
Thomas Beckham ◽  
Mary Frances McAleer ◽  
Jason Michael Johnson ◽  
Ying Yuan ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Brain Metastases ◽  
External Beam Radiotherapy ◽  
Lessons Learned ◽  
Phase Iii ◽  
Secondary Outcome ◽  
Newly Diagnosed ◽  
Recurrence Rates ◽  
Multicenter Rct ◽  
Targeted Radiation Therapy

Abstract BACKGROUND Resection (R) followed by single- or multi-fraction stereotactic radiosurgery (SRT) of brain metastases (BMs) lowers resection bed recurrence compared to R alone. Nevertheless, for larger BMs, 12-month recurrence rates after R+SRT can exceed 20–30%. Aiming to improve outcomes, a permanently implanted collagen tile brachytherapy device (GammaTile, GT Medical Technologies, Tempe, AZ) utilizing Cs-131 seeds embedded within a bioresorbable collagen tile was developed and is described as Surgically Targeted Radiation Therapy (STaRT) to distinguish it from external beam radiotherapy. STaRT allows rapid, intense localized radiation dose delivery directly to the tumor bed with predictable dosimetry immediately at the time of R, which may confer reduced risk for radiation necrosis compared to other therapies. It is hypothesized that R+ STaRT will increase surgical bed recurrence-free survival (SB-RFS), while reducing impact on functional and neurocognitive status compared to R+SRT. METHODS Multicenter, randomized, comparison trial of patients with resectable, previously untreated “index” BMs (≥ 2.5–5cm), and 0–3 other tumors, will be preoperatively randomized 1:1 to undergo R+SRT or R+STaRT to the index lesion; unresected tumors in both groups will receive SRT. Planned sample size is 180 from 14 sites. Enrollment opened 03/31/2021. First subject was enrolled 04/07/2021. Primary endpoint is SB-RFS. Secondary endpoints include overall survival, quality of life, neurocognition, functional status, imaging findings and adverse events. Follow-up will be through 24 months. This will be the first randomized trial comparing R+SRT versus R+STaRT delivered by Cs-131 sources in permanently implanted resorbable collagen tile carriers. Primary and secondary outcome measures captured will elucidate the potential risks and benefits of these two RT delivery methods in the setting of newly diagnosed BMs. We will present trial accrual progress, available data, experience and lessons learned.

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