Functional Lung Avoidance SPECT-guided Radiation Therapy of Lung Cancer

Not Applicable

Recruiting

• Conditions: Lung Cancer; Radiation-Induced Disorder; Radiation Pneumonitis; Pulmonary Disease; Lung Function Decreased
• Interventions: Diagnostic Test: Single-photon-emission CT scan

• Registration Number: NCT04676828
• Lead Sponsor: University of Aarhus

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2020-12-15
• Study First Submitted QC: 2020-12-15
• Study First Posted: 2020-12-21
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-20
• Primary Completion: 2023-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 195

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPECT functional avoidance treatment	Single-photon-emission CT scan	SPECT-based radiation therapy given taken functional distribution in the lung into account, that avoids highly functional lung volumes sparing them from radiation.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Loco-regional control rate	at 12 months	freedom from local disease progression
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

Trial Locations

Locations (2)

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

Department of Oncology, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark