Functional Lung Avoidance SPECT-guided Radiation Therapy of Lung Cancer
NCT ID: NCT04676828
Last Updated: 2022-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
195 participants
INTERVENTIONAL
2020-12-01
2024-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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SPECT functional avoidance treatment
SPECT-based radiation therapy given taken functional distribution in the lung into account, that avoids highly functional lung volumes sparing them from radiation.
Single-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
Standard treatment
CT-based radiation therapy given over 5- 6.5 weeks.
No interventions assigned to this group
Interventions
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Single-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
Eligibility Criteria
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Inclusion Criteria
* 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
* previous radiotherapy to the thorax
* other uncontrolled malignancies; any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
18 Years
ALL
No
Sponsors
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Westmead and Blacktown Hospital, Sydney West Radiation Oncology Network, Sydney, Australia
UNKNOWN
Aarhus University Hospital
OTHER
University of Aarhus
OTHER
Responsible Party
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Katherina Farr, MD, PhD
Specialist in Clinical Oncology
Locations
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Sydney West Radiation Oncology Network Westmead and Blacktown Hospitals
Sydney, New South Wales, Australia
Department of Oncology, Aarhus University Hospital
Aarhus, , Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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KFE-1930
Identifier Type: -
Identifier Source: org_study_id
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