Functional Lung Avoidance SPECT-guided Radiation Therapy of Lung Cancer

Lung Cancer Clinical Trial

— ASPECT  

Official title:

Functional Lung Avoidance SPECT-guided (ASPECT) Radiation Therapy for Lung Cancer Patients: Phase II Randomised Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04676828
• Other study ID #: KFE-1930
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2022
• Source: University of Aarhus
• Contact: Katherina Farr, MD PhD
• Phone: +4550303580
• Email: katherina[@]oncology.au.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 195
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Australia	Sydney West Radiation Oncology Network Westmead and Blacktown Hospitals	Sydney	New South Wales
Denmark	Department of Oncology, Aarhus University Hospital	Aarhus

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, Westmead and Blacktown Hospital, Sydney West Radiation Oncology Network, Sydney, Australia

Countries where clinical trial is conducted

Australia,  Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Progression-free survival	time from randomization to disease progression at any site or death	at 12 months
Secondary	Overall survival	time from randomization to death of any cause or last date known alive	at 12 months
Secondary	Loco-regional control rate	freedom from local disease progression	at 12 months