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A Phase II Multi-institutional Clinical Trial Assessing Fractionated Simultaneous In-Field Boost Radiotherapy for

George Rodrigues1, Slav Yartsev2, David Roberge3

  • 1Radiation Oncology, London Regional Cancer Program, London Health Sciences Centre, London, CAN.

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|January 17, 2020
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Summary
This summary is machine-generated.

Fractionated radiotherapy for brain oligometastases showed non-inferior intracranial lesion control compared to historical data. This approach, delivering 60 Gy in 10 fractions, offers a potential alternative to single-fraction radiosurgery.

Keywords:
brain metastasesclinical trialoligometastasesphase iiradiotherapy

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Area of Science:

  • Radiation Oncology
  • Neurosurgery
  • Clinical Trials

Background:

  • Fractionated lesional radiotherapy (60 Gy/10 fractions) is a potential alternative to single-fraction radiosurgery for brain oligometastases.
  • Preclinical and Phase I data support its efficacy.

Purpose of the Study:

  • To evaluate the efficacy and safety of fractionated lesional radiotherapy for brain oligometastases.
  • To determine if this approach is non-inferior to RTOG 9508 historical controls in overall survival (OS), intracranial control (ICC), and intracranial lesion (ILC).

Main Methods:

  • A Phase II clinical trial (NCT01543542) enrolled 87 patients.
  • Patients received 60 Gy in 10 fractions of lesional radiotherapy concurrently with 30 Gy in 10 fractions of whole-brain helical tomotherapy.
  • Non-inferiority was defined as no more than a 2-month decrease in median OS or a 10% decrease in 6-month ICC/ILC compared to RTOG 9508.

Main Results:

  • Median OS was 5.4 months.
  • Six-month estimates for ICC and ILC were 78% and 89%, respectively.
  • Intracranial lesion control (ILC) was statistically non-inferior to historical controls (p=0.02). Overall survival (p=0.09) and intracranial control (p=0.31) did not meet non-inferiority criteria.
  • Two patients (2.3%) developed suspected asymptomatic radionecrosis.

Conclusions:

  • Phase II estimates demonstrated non-inferiority of intracranial lesion control (ILC) for fractionated radiotherapy compared to RTOG 9508.
  • Fractionated lesional radiotherapy is a viable alternative for brain oligometastases, warranting further investigation.