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- Title
Canadian Phase III Randomized Trial of Stereotactic Body Radiotherapy Versus Conventionally Hypofractionated Radiotherapy for Stage I, Medically Inoperable Non-Small-Cell Lung Cancer - Rationale and Protocol Design for the Ontario Clinical Oncology Group (OCOG)-LUSTRE Trial.
- Authors
Swaminath, Anand; Wierzbicki, Marcin; Parpia, Sameer; Wright, James R.; Tsakiridis, Theodoros K.; Okawara, Gordon S.; Kundapur, Vijayananda; Bujold, Alexis; Ahmed, Naseer; Hirmiz, Khalid; Kurien, Elizabeth; Filion, Edith; Gabos, Zsolt; Faria, Sergio; Louie, Alexander V.; Owen, Timothy; Wai, Elaine; Ramchandar, Kevin; Chan, Elisa K.; Julian, Jim
- Abstract
We describe a Canadian phase III randomized controlled trial of stereotactic body radiotherapy (SBRT) versus conventionally hypofractionated radiotherapy (CRT) for the treatment of stage I medically inoperable non-small-cell lung cancer (OCOG-LUSTRE Trial). Eligible patients are randomized in a 2:1 fashion to either SBRT (48 Gy in 4 fractions for peripherally located lesions; 60 Gy in 8 fractions for centrally located lesions) or CRT (60 Gy in 15 fractions). The primary outcome of the study is 3-year local control, which we hypothesize will improve from 75% with CRT to 87.5% with SBRT. With 85% power to detect a difference of this magnitude (hazard ratio = 0.46), a 2-sided α = 0.05 and a 2:1 randomization, we require a sample size of 324 patients (216 SBRT, 108 CRT). Important secondary outcomes include overall survival, disease-free survival, toxicity, radiation-related treatment death, quality of life, and cost-effectiveness. A robust radiation therapy quality assurance program has been established to assure consistent and high quality SBRT and CRT delivery. Despite widespread interest and adoption of SBRT, there still remains a concern regarding long-term control and risks of toxicity (particularly in patients with centrally located lesions). The OCOG-LUSTRE study is the only randomized phase III trial testing SBRT in a medically inoperable population, and the results of this trial will attempt to prove that the benefits of SBRT outweigh the potential risks.
- Subjects
COMPARATIVE studies; EXPERIMENTAL design; LONGITUDINAL method; LUNG cancer; LUNG tumors; RESEARCH methodology; MEDICAL cooperation; PROGNOSIS; QUALITY of life; RADIATION doses; RADIOSURGERY; RESEARCH; TUMOR classification; EVALUATION research; RANDOMIZED controlled trials
- Publication
Clinical Lung Cancer, 2017, Vol 18, Issue 2, p250
- ISSN
1525-7304
- Publication type
journal article
- DOI
10.1016/j.cllc.2016.08.002