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Functional Lung Avoidance SPECT-guided Radiation Therapy of Lung Cancer

RECRUITING

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.

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Study details:

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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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2020-12-01

Primary completion: 2023-12-01

Study completion finish: 2024-12-01

Study type

TREATMENT

Phase

Trial ID

NCT04676828

Intervention or treatment

DIAGNOSTIC_TEST: Single-photon-emission CT scan

Conditions

• Lung Cancer
• Radiation-Induced Disorder
• Radiation Pneumonitis
• Pulmonary Disease
• Lung Function Decreased

Condition: Lung Cancer, Radiation-Induced Disorder and more
DIAGNOSTIC_TEST: Single-photon-emission CT scan
Sydney, New South Wales, Australia
Sponsor: University of Aarhus

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Sydney West Radiation Oncology Network Westmead and Blacktown Hospitals

Research sites nearby

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Sydney West Radiation Oncology Network Westmead and Blacktown Hospitals
Sydney, New South Wales, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 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.	DIAGNOSTIC_TEST: 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
NO_INTERVENTION: Standard treatment CT-based radiation therapy given over 5- 6.5 weeks.	Not specified

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome 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

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome 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	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

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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References

Clinical Trials Gov: Functional Lung Avoidance SPECT-guided Radiation Therapy of Lung Cancer