PMID- 27876603 OWN - NLM STAT- MEDLINE DCOM- 20170926 LR - 20181202 IS - 1938-0690 (Electronic) IS - 1525-7304 (Linking) VI - 18 IP - 2 DP - 2017 Mar TI - 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. PG - 250-254 LID - S1525-7304(16)30224-8 [pii] LID - 10.1016/j.cllc.2016.08.002 [doi] AB - 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 alpha = 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. CI - Copyright (c) 2016 Elsevier Inc. All rights reserved. FAU - Swaminath, Anand AU - Swaminath A AD - Department of Oncology, McMaster University, Hamilton, Ontario, Canada. Electronic address: swaminath@hhsc.ca. FAU - Wierzbicki, Marcin AU - Wierzbicki M AD - Department of Medical Physics, McMaster University, Hamilton, Ontario, Canada. FAU - Parpia, Sameer AU - Parpia S AD - Department of Oncology, McMaster University, Hamilton, Ontario, Canada; Ontario Clinical Oncology Group, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada. FAU - Wright, James R AU - Wright JR AD - Department of Oncology, McMaster University, Hamilton, Ontario, Canada. FAU - Tsakiridis, Theodoros K AU - Tsakiridis TK AD - Department of Oncology, McMaster University, Hamilton, Ontario, Canada. FAU - Okawara, Gordon S AU - Okawara GS AD - Department of Oncology, McMaster University, Hamilton, Ontario, Canada. FAU - Kundapur, Vijayananda AU - Kundapur V AD - Department of Radiation Oncology, University of Saskatchewan, Saskatoon, Saskatchewan, Canada. FAU - Bujold, Alexis AU - Bujold A AD - Departement de Radio-oncologie Clinique-Enseignement-Recherche, Centre Hospitalier de l'Universite de Montreal - Hopital Maisonneuve-Rosemont, Montreal, Quebec, Canada. FAU - Ahmed, Naseer AU - Ahmed N AD - Department of Radiation Oncology, CancerCare Manitoba, Winnipeg, Manitoba, Canada. FAU - Hirmiz, Khalid AU - Hirmiz K AD - Department of Radiation Oncology, Windsor Regional Cancer Centre, Windsor, Ontario, Canada. FAU - Kurien, Elizabeth AU - Kurien E AD - Department of Oncology, University of Calgary, Calgary, Alberta, Canada. FAU - Filion, Edith AU - Filion E AD - Radiation Oncology Department, Centre Hospitalier de l'Universite de Montreal, Notre Dame Hospital, Montreal, Quebec, Canada. FAU - Gabos, Zsolt AU - Gabos Z AD - Department of Oncology, University of Alberta, Edmonton, Alberta, Canada. FAU - Faria, Sergio AU - Faria S AD - Department of Radiation Oncology, McGill University Health Centre, Montreal, Quebec, Canada. FAU - Louie, Alexander V AU - Louie AV AD - Department of Radiation Oncology, University of Western Ontario, London, Ontario, Canada. FAU - Owen, Timothy AU - Owen T AD - Department of Oncology, Queen's University, Kingston, Ontario, Canada. FAU - Wai, Elaine AU - Wai E AD - Department of Surgery, University of British Columbia, Victoria, British Columbia, Canada. FAU - Ramchandar, Kevin AU - Ramchandar K AD - Department of Oncology, Northern Ontario School of Medicine, Thunder Bay, Ontario, Canada. FAU - Chan, Elisa K AU - Chan EK AD - Department of Radiation Oncology, Dalhousie University, Saint John, New Brunswick, Canada. FAU - Julian, Jim AU - Julian J AD - Department of Oncology, McMaster University, Hamilton, Ontario, Canada; Ontario Clinical Oncology Group, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada. FAU - Cline, Kathryn AU - Cline K AD - Ontario Clinical Oncology Group, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada. FAU - Whelan, Timothy J AU - Whelan TJ AD - Department of Oncology, McMaster University, Hamilton, Ontario, Canada; Ontario Clinical Oncology Group, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada. LA - eng PT - Clinical Trial, Phase III PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20161003 PL - United States TA - Clin Lung Cancer JT - Clinical lung cancer JID - 100893225 SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Carcinoma, Non-Small-Cell Lung/pathology/*radiotherapy/*surgery MH - *Dose Fractionation, Radiation MH - Female MH - Follow-Up Studies MH - Humans MH - Lung Neoplasms/pathology/*radiotherapy/*surgery MH - Male MH - Middle Aged MH - Neoplasm Staging MH - Prognosis MH - Quality of Life MH - *Radiosurgery MH - *Research Design OTO - NOTNLM OT - Local control OT - Quality assurance OT - Quality of life OT - Radiation OT - Toxicity EDAT- 2016/11/24 06:00 MHDA- 2017/09/28 06:00 CRDT- 2016/11/24 06:00 PHST- 2016/08/16 00:00 [received] PHST- 2016/08/23 00:00 [accepted] PHST- 2016/11/24 06:00 [pubmed] PHST- 2017/09/28 06:00 [medline] PHST- 2016/11/24 06:00 [entrez] AID - S1525-7304(16)30224-8 [pii] AID - 10.1016/j.cllc.2016.08.002 [doi] PST - ppublish SO - Clin Lung Cancer. 2017 Mar;18(2):250-254. doi: 10.1016/j.cllc.2016.08.002. Epub 2016 Oct 3.