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Recruiting Not applicable NCT04676828

Functional Lung Avoidance SPECT-guided Radiation Therapy of Lung Cancer

No applicable phase (e.g. observational)
Conditions: Lung Cancer Radiation-Induced Disorder Radiation Pneumonitis Pulmonary Disease Lung Function Decreased

Sponsor: University of Aarhus

trial.available_in: БГ
Overview
Study aims to determine if functional lung avoidance based on perfusion single photon emission (SPECT)/CT scan, improves toxicity outcomes for patients with advanced lung cancer undergoing chemo-radiotherapy. Functional avoidance implies a dose plan that takes functional distribution in the lung into account, and avoids highly functional lung volumes sparing them from radiation.
Description
In this project, a novel method of safe radiotherapy delivery shall be tested for patients with lung cancer in a clinical setting. Functional avoidance radiotherapy is a new method that protect highly functional lung tissue from radiation, while delivering high dose radiotherapy to the lung tumour. Radiotherapy is usually based on a CT scan that does not account for functional variations in the lungs. Therefore, I hypothesize that using functional distribution in the lungs and avoiding irradiation of highly functional lung will improve treatment outcome for individual patients with lung cancer. The objective of my project is to determine if functional image guided radiotherapy (functional avoidance radiotherapy) improves toxicity outcomes for patients with lung cancer undergoing curative chemo-radiotherapy in a prospective clinical trial. To reach this objective, the impact of functional avoidance radiotherapy on pulmonary toxicity measured by the incidence and severity of radiation-induced lung disease shall be assessed. Additionally, loco-regional control, time to progression, overall survival, quality of life and radiation-induced molecular response in patients treated with functional avoidance radiotherapy shall be assessed and compared to patients receiving standard treatment.
Who can participate
Inclusion Criteria: * histologically verified lung cancer (small-cell and non-small cell lung cancer) * referred for radiotherapy with curative intent * radiation dose of 60-66 Gy given in 2-Gy fractions, other dose levels and fractionation schedules accepted, as per site standard * concurrent chemotherapy is accepted * patients with oligometastatic disease are allowed, where metastasis have been ablated with surgery or radiotherapy * receiving (chemo)-radiotherapy to the thoracic disease with curative intent * adults over 18, that have given oral and written informed consent before patient registration. Exclusion Criteria: * concurrent immunotherapy * previous radiotherapy to the thorax * other uncontrolled malignancies; any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
Locations 2
Australia (1)
Sydney West Radiation Oncology Network Westmead and Blacktown Hospitals
Sydney , New South Wales
Denmark (1)
Department of Oncology, Aarhus University Hospital
Aarhus
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.12.2021
Completion date
01.12.2028
Registry ID
NCT04676828
Source
anzctr
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