Lung Cancer, Lung Function Decreased, Pulmonary Disease, Radiation-Induced Disorder, Radiation Pneumonitis
Conditions
Keywords
radiation-induced lung toxicity, functional avoidance methodology, radiation therapy of lung cancer
Brief summary
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.
Detailed 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.
Interventions
DIAGNOSTIC_TESTSingle-photon-emission CT scan
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
Sponsors
University of Aarhus
Westmead and Blacktown Hospital, Sydney West Radiation Oncology Network, Sydney, Australia
Aarhus University Hospital
South Eastern Sydney Local Health District
The University of New South Wales
Northern NSW Local Health District, NSW Australia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Participants, care providers and outcome assessors are blinded
Intervention model description
Randomized double-blinded phase 2
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiation-induced lung toxicity | Measured serially from 1 to 12 months after treatment completion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | Measured serially from 1 to 12 months after treatment completion | Change in quality of life according to the European Organisation for Research and Treatment of Cancer quality of life questionnaires |
| Patient reported lung symptoms | Measured serially from 1 to 12 months after treatment completion | Change in lung symptoms according to the European Organisation for Research and Treatment of Cancer questionnaire |
| Progression-free survival | at 12 months | time from randomization to disease progression at any site or death |
| Overall survival | at 12 months | time from randomization to death of any cause or last date known alive |
| Loco-regional control rate | at 12 months | freedom from local disease progression |
Countries
Australia, Denmark
Contacts
CONTACTKatherina Farr, MD PhD FRACP
Outcome results
None listed