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NCT Number: NCT04676828

Functional Lung Avoidance SPECT-guided Radiation Therapy of Lung Cancer

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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Key information

Conditions

Lung Cancer Abnormalities, Radiation-Induced Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Lung Diseases Lung Diseases, Interstitial Lung Function Decreased Lung Injury Lung Neoplasms Neoplasms Neoplasms by Site Pulmonary Disease Radiation Injuries Radiation Pneumonitis Radiation-Induced Disorder Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Radiation-induced lung toxicity

    Time frame: 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 outcomes

  1. Quality of life

    Time frame: 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

  2. Patient reported lung symptoms

    Time frame: 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

  3. Progression-free survival

    Time frame: at 12 months

    time from randomization to disease progression at any site or death

  4. Overall survival

    Time frame: at 12 months

    time from randomization to death of any cause or last date known alive

  5. Loco-regional control rate

    Time frame: at 12 months

    freedom from local disease progression

Study contacts

Contact information is provided by the study sponsor or research team.

Katherina Farr, MD PhD FRACP

CONTACT

[email protected]

+61 412695410

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital
  • Northern NSW Local Health District, NSW Australia
  • South Eastern Sydney Local Health District
  • The University of New South Wales
  • Westmead and Blacktown Hospital, Sydney West Radiation Oncology Network, Sydney, Australia

Registry information

Official study title

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

Acronym: ASPECT

Important dates

Study start
2021
Primary completion
2027
Study completion
2028
First posted
Dec 21, 2020
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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