A Phase II Multi-institutional Clinical Trial Assessing Fractionated Simultaneous In-Field Boost Radiotherapy for Brain Oligometastases
| Autor: | Jason Pantarotto, David Roberge, Slav Yartsev, Brian Yaremko, Edward Yu, Carole Lambert, Wilson Roa, Belal Ahmad, A. Rashid Dar, Giuseppina Laura Masucci, George Rodrigues, David D'Souza, David A. Palma, Glenn Bauman, B.J. Fisher, Robert MacRae, Valerie Panet-Raymond, Tracy Sexton, Gregory R. Pond, Keng Yeow Tay |
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| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
medicine.medical_treatment
Phases of clinical research 030204 cardiovascular system & hematology Asymptomatic Tomotherapy Lesion 03 medical and health sciences 0302 clinical medicine Statistical significance brain metastases medicine radiotherapy business.industry General Engineering clinical trial phase ii oligometastases Clinical trial Radiation therapy Oncology Radiation Oncology Intracranial lesions medicine.symptom Nuclear medicine business 030217 neurology & neurosurgery |
| Zdroj: | Cureus |
| ISSN: | 2168-8184 |
| Popis: | Purpose/Objective Published preclinical and phase I clinical trial data suggest that fractionated lesional radiotherapy with 60 Gy in 10 fractions can serve as an alternative approach to single fraction radiosurgical boost for brain oligometastases. Methods and Materials A phase II clinical trial (NCT01543542) of a total of 60 Gy in 10 fractions of lesional (one to three) radiotherapy (given simultaneously with whole-brain helical tomotherapy with 30 Gy in 10 fractions) was conducted at five institutions. We hypothesized that fractionated radiotherapy would be considered unsuitable if the median overall survival (OS) was degraded by two months or if six-month intracranial control (ICC) and intracranial lesion (ILC) were inferior by 10% compared with the published RTOG 9508 results. Results A total of 87 patients were enrolled over a 4.5-year accrual period. Radiological lesion and extralesional central nervous system progression were documented in 15/87 (17%) and 11/87 (13%) patients, respectively. Median OS for all patients was 5.4 months. Six-month actuarial estimates of ICC and ILC were 78% and 89%, respectively. However, only the ILC estimate achieved statistical significance (p=0.02), demonstrating non-inferiority to the a priori historical controls (OS: p=0.09, ICC=0.31). Two patients developed suspected asymptomatic radionecrosis. Conclusions The phase II estimates of ILC were demonstrated to be non-inferior to the results of the RTOG 9508. |
| Databáze: | OpenAIRE |
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