Personal innovative approach in radiation therapy of lung cancer- functional lung avoidance SPECT-guided (ASPECT) radiation therapy: a study protocol for phase II randomised double-blind clinical trial

BMC Cancer

Tine Bisballe Nyeng¹  Katherina P. Farr¹  Azza Ahmed Khalil¹  Ditte Sloth Møller¹  Stine Kramer¹  Marianne Knap¹  Cai Grau¹  Lone Hoffmann¹  Eric Hau²  Katrina West²  Val Gebski²  Harriet Gee²  David Farlow³ 

[1]Aarhus University Hospital

[2]Department of Radiation Oncology, Crown Princess Mary Cancer Centre, Westmead Hospital, Sydney West Radiation Oncology Network

[3]Westmead Hospital

关键词: Lung cancer;    Radiation therapy;    Radiation-induced lung toxicity;    Functional imaging;    Perfusion SPECT/CT;   

DOI  :  10.1186/s12885-021-08663-1

来源: DOAJ

【 摘 要 】

Abstract Background Radiation therapy (RT) plays a key role in curative-intent treatment for locally advanced lung cancer. Radiation induced pulmonary toxicity can be significant for some patients and becomes a limiting factor for radiation dose, suitability for treatment, as well as post treatment quality of life and suitability for the newly introduced adjuvant immunotherapy. Modern RT techniques aim to minimise the radiation dose to the lungs, without accounting for regional distribution of lung function. Many lung cancer patients have significant regional differences in pulmonary function due to smoking and chronic lung co-morbidity. Even though reduction of dose to functional lung has shown to be feasible, the method of preferential functional lung avoidance has not been investigated in a randomised clinical trial. Methods In this study, single photon emission computed tomography (SPECT/CT) imaging technique is used for functional lung definition, in conjunction with advanced radiation dose delivery method in randomised, double-blind trial. The study aims to assess the impact of functional lung avoidance technique on pulmonary toxicity and quality of life in patients receiving chemo-RT for lung cancer. Eligibility criteria are biopsy verified lung cancer, scheduled to receive (chemo)-RT with curative intent. Every patient will undergo a pre-treatment perfusion SPECT/CT to identify functional lung. At radiation dose planning, two plans will be produced for all patients on trial. Standard reference plan, without the use of SPECT imaging data, and functional avoidance plan, will be optimised to reduce the dose to functional lung within the predefined constraints. Both plans will be clinically approved. Patients will then be randomised in a 2:1 ratio to be treated according to either the functional avoidance or the standard plan. This study aims to accrue a total of 200 patients within 3 years. The primary endpoint is symptomatic radiation-induced lung toxicity, measured serially 1–12 months after RT. Secondary endpoints include: a quality of life and patient reported lung symptoms assessment, overall survival, progression-free survival, and loco-regional disease control. Discussion ASPECT trial will investigate functional avoidance method of radiation delivery in clinical practice, and will establish toxicity outcomes for patients with lung cancer undergoing curative chemo-RT. Trial registration Clinicaltrials.gov Identifier: NCT04676828 . Registered 1 December 2020.

【 授权许可】

Unknown