Single vs. multiple fraction non-inferiority trial of stereotactic ablative radiotherapy for the comprehensive treatment of oligo-metastases/progression: SIMPLIFY-SABR-COMET.

Cancer Oligometastases Quality of Life Single Fraction Stereotactic ablative radiotherapy Survival

Journal

BMC cancer

ISSN: 1471-2407

Titre abrégé: BMC Cancer

Pays: England

ID NLM: 100967800

Informations de publication

Date de publication:
03 Feb 2024

Historique:

received: 18 12 2023

accepted: 21 01 2024

medline: 4 2 2024

pubmed: 4 2 2024

entrez: 3 2 2024

Statut: epublish

Résumé

Radiotherapy delivery regimens can vary between a single fraction (SF) and multiple fractions (MF) given daily for up to several weeks depending on the location of the cancer or metastases. With limited evidence comparing fractionation regimens for oligometastases, there is support to explore toxicity levels to nearby organs at risk as a primary outcome while using SF and MF stereotactic ablative radiotherapy (SABR) as well as explore differences in patient-reported quality of life and experience. This study will randomize 598 patients in a 1:1 ratio between the standard arm (MF SABR) and the experimental arm (SF SABR). This trial is designed as two randomized controlled trials within one patient population for resource efficiency. The primary objective of the first randomization is to determine if SF SABR is non-inferior to MF SABR, with respect to healthcare provider (HCP)-reported grade 3-5 adverse events (AEs) that are related to SABR. Primary endpoint is toxicity while secondary endpoints include lesional control rate (LCR), and progression-free survival (PFS). The second randomization (BC Cancer sites only) will allocate participants to either complete quality of life (QoL) questionnaires only; or QoL questionnaires and a symptom-specific survey with symptom-guided HCP intervention. The primary objective of the second randomization is to determine if radiation-related symptom questionnaire-guided HCP intervention results in improved reported QoL as measured by the EuroQoL-5-dimensions-5levels (EQ-5D-5L) instrument. The primary endpoint is patient-reported QoL and secondary endpoints include: persistence/resolution of symptom reporting, QoL, intervention cost effectiveness, resource utilization, and overall survival. This study will compare SF and MF SABR in the treatment of oligometastases and oligoprogression to determine if there is non-inferior toxicity for SF SABR in selected participants with 1-5 oligometastatic lesions. This study will also compare patient-reported QoL between participants who receive radiation-related symptom-guided HCP intervention and those who complete questionnaires alone. Clinicaltrials.gov identifier: NCT05784428. Date of Registration: 23 March 2023.

Sections du résumé

BACKGROUND BACKGROUND

METHODS METHODS

This study will randomize 598 patients in a 1:1 ratio between the standard arm (MF SABR) and the experimental arm (SF SABR). This trial is designed as two randomized controlled trials within one patient population for resource efficiency. The primary objective of the first randomization is to determine if SF SABR is non-inferior to MF SABR, with respect to healthcare provider (HCP)-reported grade 3-5 adverse events (AEs) that are related to SABR. Primary endpoint is toxicity while secondary endpoints include lesional control rate (LCR), and progression-free survival (PFS). The second randomization (BC Cancer sites only) will allocate participants to either complete quality of life (QoL) questionnaires only; or QoL questionnaires and a symptom-specific survey with symptom-guided HCP intervention. The primary objective of the second randomization is to determine if radiation-related symptom questionnaire-guided HCP intervention results in improved reported QoL as measured by the EuroQoL-5-dimensions-5levels (EQ-5D-5L) instrument. The primary endpoint is patient-reported QoL and secondary endpoints include: persistence/resolution of symptom reporting, QoL, intervention cost effectiveness, resource utilization, and overall survival.

DISCUSSION CONCLUSIONS

This study will compare SF and MF SABR in the treatment of oligometastases and oligoprogression to determine if there is non-inferior toxicity for SF SABR in selected participants with 1-5 oligometastatic lesions. This study will also compare patient-reported QoL between participants who receive radiation-related symptom-guided HCP intervention and those who complete questionnaires alone.

TRIAL REGISTRATION BACKGROUND

Clinicaltrials.gov identifier: NCT05784428. Date of Registration: 23 March 2023.

Identifiants

DOI: 10.1186/s12885-024-11905-7 PMID: 38310262

pubmed: 38310262

doi: 10.1186/s12885-024-11905-7

pii: 10.1186/s12885-024-11905-7

doi:

Banques de données

ClinicalTrials.gov

['NCT05784428']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

Pagination

171

Informations de copyright

Références

Hellman S, Weichselbaum RR. Oligometastases. J Clin Oncol. 1995;13(1):8–10.

doi: 10.1200/JCO.1995.13.1.8 pubmed: 7799047

Patel PH, Palma D, McDonald F, Tree AC. The dandelion dilemma revisited for oligoprogression: treat the whole lawn or weed selectively? Clin Oncol (R Coll Radiol). 2019;31(12):824–33.

doi: 10.1016/j.clon.2019.05.015 pubmed: 31182289

Rowe SP, Tran PT, Fishman EK, Johnson PT. Oligoprogression: what radiologists need to know about this emerging concept in cancer therapeutic decision-making. Acad Radiol. 2017;24(7):898–900.

doi: 10.1016/j.acra.2016.12.018 pubmed: 28341411

Chan OSH, Lam KC, Li JYC, Choi FPT, Wong CYH, Chang ATY, et al. ATOM: A phase II study to assess efficacy of preemptive local ablative therapy to residual oligometastases of NSCLC after EGFR TKI. Lung Cancer. 2020;142:41–6.

doi: 10.1016/j.lungcan.2020.02.002 pubmed: 32088604

Schellenberg D, Gabos Z, Duimering A, Debenham BJ, Fairchild A, Huang F, et al. Stereotactic Ablative Radiotherapy for Oligo-Progressive Cancers: Results of the Randomized Phase II STOP Trial. Int J Radiat Oncol Biol Phys. 2023;117(2, Supplement):S58.

Baker S, Jiang W, Mou B, Lund CR, Liu M, Bergman AM, et al. Progression-free survival and local control after SABR for up to 5 oligometastases: an analysis from the population-based phase 2 SABR-5 Trial. Int J Radiat Oncol Biol Phys. 2022;114(4):617–26.

doi: 10.1016/j.ijrobp.2022.05.033 pubmed: 35667528

Baker S, Mou B, Jiang W, Liu M, Bergman AM, Schellenberg D, et al. Predictors of early polymetastatic relapse after SABR for up to 5 Oligometastases: a Secondary analysis of the phase II SABR-5 trial. Int J Radiat Oncol Biol Phys. 2022;114(5):856–61.

doi: 10.1016/j.ijrobp.2022.06.094 pubmed: 35840110

Olson RA, Jiang W, Liu MC, Bergman A, Schellenberg D, Mou B, et al. Population Based Phase II Trial of Stereotactic Ablative Radiotherapy (SABR) for up to 5 Oligometastases: Preliminary Results of the SABR-5 Trial. Int J Radiat Oncol Biol Phys. 2021;111(3, Supplement):S4.

Siva S, Kirby K, Caine H, Pham D, Kron T, Te Marvelde L, et al. Comparison of single-fraction and multi-fraction stereotactic radiotherapy for patients with 18F-fluorodeoxyglucose positron emission tomography-staged pulmonary oligometastases. Clin Oncol (R Coll Radiol). 2015;27(6):353–61.

doi: 10.1016/j.clon.2015.01.004 pubmed: 25698068

Siva S, Bressel M, Mai T, Le H, Vinod S, de Silva H, et al. Single-Fraction vs Multifraction Stereotactic Ablative Body Radiotherapy for Pulmonary Oligometastases (SAFRON II): The Trans Tasman Radiation Oncology Group 13.01 Phase 2 Randomized Clinical Trial. JAMA Oncol. 2021;7(10):1476–85.

doi: 10.1001/jamaoncol.2021.2939 pubmed: 34455431 pmcid: 8404145

Siva S, Sakyanun P, Mai T, Wong W, Lim A, Ludbrook J, et al. Long-Term Outcomes of TROG 13.01 SAFRON II Randomized Trial of Single- Versus Multifraction Stereotactic Ablative Body Radiotherapy for Pulmonary Oligometastases. J Clin Oncol. 2023;41(19):3493–8.

doi: 10.1200/JCO.23.00150 pubmed: 37179526

Zelefsky MJ, Yamada Y, Greco C, Lis E, Schöder H, Lobaugh S, et al. Phase 3 Multi-Center, Prospective, Randomized Trial Comparing Single-Dose 24 Gy Radiation Therapy to a 3-Fraction SBRT Regimen in the Treatment of Oligometastatic Cancer. Int J Radiat Oncol Biol Phys. 2021;110(3):672–9.

doi: 10.1016/j.ijrobp.2021.01.004 pubmed: 33422612 pmcid: 9472455

Basch E, Deal AM, Kris MG, Scher HI, Hudis CA, Sabbatini P, et al. Symptom monitoring with patient-reported outcomes during routine cancer treatment: a randomized controlled trial. J Clin Oncol. 2016;34(6):557–65.

doi: 10.1200/JCO.2015.63.0830 pubmed: 26644527

Olson R, Mathews L, Liu M, Schellenberg D, Mou B, Berrang T, et al. Stereotactic ablative radiotherapy for the comprehensive treatment of 1–3 Oligometastatic tumors (SABR-COMET-3): study protocol for a randomized phase III trial. BMC Cancer. 2020;20(1):380.

doi: 10.1186/s12885-020-06876-4 pubmed: 32370765 pmcid: 7201684

Fisher CG, DiPaola CP, Ryken TC, Bilsky MH, Shaffrey CI, Berven SH, et al. A novel classification system for spinal instability in neoplastic disease: an evidence-based approach and expert consensus from the Spine Oncology Study Group. Spine (Phila Pa 1976). 2010;35(22):E1221-9.

Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, et al. The functional assessment of cancer therapy scale: development and validation of the general measure. J Clin Oncol. 1993;11(3):570–9.

doi: 10.1200/JCO.1993.11.3.570 pubmed: 8445433

Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001;33(5):337–43.

doi: 10.3109/07853890109002087 pubmed: 11491192

Nguyen TK, Chin L, Sahgal A, Dagan R, Eppinga W, Guckenberger M, et al. International Multi-institutional Patterns of Contouring Practice and Clinical Target Volume Recommendations for Stereotactic Body Radiation Therapy for Non-Spine Bone Metastases. Int J Radiat Oncol Biol Phys. 2022;112(2):351–60.

doi: 10.1016/j.ijrobp.2021.09.004 pubmed: 34509549

Redmond KJ, Robertson S, Lo SS, Soltys SG, Ryu S, McNutt T, et al. Consensus Contouring Guidelines for Postoperative Stereotactic Body Radiation Therapy for Metastatic Solid Tumor Malignancies to the Spine. Int J Radiat Oncol Biol Phys. 2017;97(1):64–74.

doi: 10.1016/j.ijrobp.2016.09.014 pubmed: 27843035

Cox BW, Spratt DE, Lovelock M, Bilsky MH, Lis E, Ryu S, et al. International Spine Radiosurgery Consortium consensus guidelines for target volume definition in spinal stereotactic radiosurgery. Int J Radiat Oncol Biol Phys. 2012;83(5):e597-605.

doi: 10.1016/j.ijrobp.2012.03.009 pubmed: 22608954

Dunne EM, Sahgal A, Lo SS, Bergman A, Kosztyla R, Dea N, et al. International consensus recommendations for target volume delineation specific to sacral metastases and spinal stereotactic body radiation therapy (SBRT). Radiother Oncol. 2020;145:21–9.

doi: 10.1016/j.radonc.2019.11.026 pubmed: 31874346

Klein EE, Hanley J, Bayouth J, Yin FF, Simon W, Dresser S, et al. Task Group 142 report: quality assurance of medical accelerators. Med Phys. 2009;36(9):4197–212.

doi: 10.1118/1.3190392 pubmed: 19810494

Hubbard W. International conference on harmonisation; guidance on statistical principles for clinical trials; availability–FDA Notice. Fed Regist. 1998;63(179):49583–98.

De Oliveira C, Pataky R, Bremner KE, Rangrej J, Chan KK, Cheung WY, et al. Estimating the cost of cancer care in British Columbia and Ontario: a Canadian inter-provincial comparison. Healthc Policy. 2017;12(3):95–108.

pubmed: 28277207 pmcid: 5344366

Guidelines for the Economic Evaluation of Health Technologies: Canada 4th Edition CADTH METHODS AND GUIDELINES Service Line: CADTH Methods and Guidelines. 2017.

Canada S. Table 18-10-0004-13 Consumer Price Index by product group, monthly, percentage change, not seasonally adjustedCanada, provinces, Whitehorse, Yellowknife and Iqaluit.; 2007.

Palma DA, Olson R, Harrow S, Gaede S, Louie AV, Haasbeek C, et al. Stereotactic ablative radiotherapy versus standard of care palliative treatment in patients with oligometastatic cancers (SABR-COMET): a randomised, phase 2, open-label trial. Lancet. 2019;393(10185):2051–8.

doi: 10.1016/S0140-6736(18)32487-5 pubmed: 30982687