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| Name | Class |
|---|---|
| Westmead and Blacktown Hospital, Sydney West Radiation Oncology Network, Sydney, Australia | UNKNOWN |
| Aarhus University Hospital | OTHER |
| South Eastern Sydney Local Health District | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPECT functional avoidance treatment | Experimental | SPECT-based radiation therapy given taken functional distribution in the lung into account, that avoids highly functional lung volumes sparing them from radiation. |
|
| Standard treatment | No Intervention | CT-based radiation therapy given over 5- 6.5 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single-photon-emission CT scan | Diagnostic Test | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Radiation-induced lung toxicity | 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. | Measured serially from 1 to 12 months after treatment completion |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Change in quality of life according to the European Organisation for Research and Treatment of Cancer quality of life questionnaires | Measured serially from 1 to 12 months after treatment completion |
| Patient reported lung symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katherina Farr, MD PhD FRACP | Contact | +61 412695410 | Katherina.Farr@health.nsw.gov.au |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sydney West Radiation Oncology Network Westmead and Blacktown Hospitals | Recruiting | Sydney | New South Wales | 2145 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34418994 | Derived | Khalil AA, Hau E, Gebski V, Grau C, Gee H, Nyeng TB, West K, Kramer S, Farlow D, Knap M, Moller DS, Hoffmann L, Farr KP. 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. 2021 Aug 21;21(1):940. doi: 10.1186/s12885-021-08663-1. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D000016 | Abnormalities, Radiation-Induced |
| D017564 | Radiation Pneumonitis |
| D008171 | Lung Diseases |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015899 | Tomography, Emission-Computed, Single-Photon |
| ID | Term |
|---|---|
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| The University of New South Wales | OTHER |
| Northern NSW Local Health District, NSW Australia | UNKNOWN |
Randomized double-blinded phase 2
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Participants, care providers and outcome assessors are blinded
Change in lung symptoms according to the European Organisation for Research and Treatment of Cancer questionnaire
| Measured serially from 1 to 12 months after treatment completion |
| Progression-free survival | time from randomization to disease progression at any site or death | at 12 months |
| Overall survival | time from randomization to death of any cause or last date known alive | at 12 months |
| Loco-regional control rate | freedom from local disease progression | at 12 months |
| Department of Oncology, Aarhus University Hospital | Recruiting | Aarhus | DK-8000 | Denmark |
|
| D012140 |
| Respiratory Tract Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
| D017563 | Lung Diseases, Interstitial |
| D055370 | Lung Injury |
| D012120 | Respiration Disorders |
| D003933 | Diagnosis |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |