Here is the design of a clinical trial:

Official Title: Functional Lung Avoidance SPECT-guided (ASPECT) Radiation Therapy for Lung Cancer Patients: Phase II Randomised Clinical Trial

Included conditions:
- Lung Cancer
- Radiation-Induced Disorder
- Radiation Pneumonitis
- Pulmonary Disease
- Lung Function Decreased

Study Armgroups:
- {'label': 'SPECT functional avoidance treatment', 'type': 'EXPERIMENTAL', 'description': 'SPECT-based radiation therapy given taken functional distribution in the lung into account, that avoids highly functional lung volumes sparing them from radiation.', 'interventionNames': ['Diagnostic Test: Single-photon-emission CT scan']}
- {'label': 'Standard treatment', 'type': 'NO_INTERVENTION', 'description': 'CT-based radiation therapy given over 5- 6.5 weeks.'}

Interventions:
- {'type': 'DIAGNOSTIC_TEST', 'name': 'Single-photon-emission CT scan', 'description': 'SPECT/CT scan is an established functional modality used in the diagnosis and monitoring of lung disease. SPECT/CT scan images pulmonary circulation, where perfused areas equate with normal functional lung', 'armGroupLabels': ['SPECT functional avoidance treatment']}

Primary Outcomes:
- {'measure': 'Radiation-induced lung toxicity', 'description': 'crude rate of symptomatic radiation-induced lung toxicity of grade 2 and higher. According to the Common Toxicity Criteria for Adverse Events version 5.0 for radiation pneumonitis, dyspnea, cough, or any other radiation-induced respiratory, thoracic and mediastinal disorder.', 'timeFrame': 'Measured serially from 1 to 12 months after treatment completion'}

Please estimate the sample size based on the assumption: 
The study aims for at least 80% power to have 95% confidence in ruling out a freedom from RILT rate of 75% in favor of 84%. A randomised phase II design with a 2:1 randomisation of SPECT to standard treatment is proposed. A modest attrition rate is accounted for.
Sample size
          Bases on the Quantitative Analyses of Normal Tissue Effects in the Clinic lung report and previously reported prospective trial rates [6], a freedom from RILT rate of 75% would be expected to be observed in patients receiving standard therapy. For the SPECT to be considered worthwhile for further investigation a freedom from RILT rate of at least 84% would suggest a clinically worthwhile signal in SPECT. Based on Ahernâs single arm design, a sample size of 130 patients receiving SPECT would have at least 80% power to have 95% confidence in ruling out an uninteresting freedom from RILT rate of 75% in favour of a clinically more interesting rate of 84%. In order to reduce selection bias, a randomised phase II design is proposed with a 2:1 randomisation of SPECT to standard treatment. The sample size of 195 is required and a total of 200 patients will be enrolled to offset a modest attrition rate. All patients will be followed for at least 6âmonths. The primary endpoint will be described by the proportion of patients in the SPECT arm are free of symptomatic RILT of at least grade 2 together with the associated 95% confidence interval. The corresponding proportion will be calculated in the control arm to provide contemporary free of symptomatic RILT of at least grade 2 rates in the standard treatment group.
          It is expected that 5â6 patients per month can be accrued between the two participating countries (Denmark and Australia), thus, it is expected that accrual to this study could be completed in 3âyears.