Functional Lung Avoidance SPECT-guided Radiation Therapy of Lung Cancer (ASPECT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer; Pulmonary Disease; Radiation Pneumonitis; Lung Function Decreased; Radiation-Induced Disorder
• Intervention / Treatment: Diagnostic test: Single-photon-emission CT scan

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.

• Study Type: Interventional
• Enrollment (Anticipated): 195
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katherina Farr, MD PhD; Phone Number: +4550303580; Email: katherina@oncology.au.dk

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2145
      • Not yet recruiting
      • Sydney West Radiation Oncology Network Westmead and Blacktown Hospitals
      • Contact: Eric Hau, MBBS PhD; Phone Number: 0432207880; Email: Eric.Hau@health.nsw.gov.au
      • Sub-Investigator: Eric Hau, MBBS PhD
• Denmark
  • Aarhus, Denmark, DK-8000
    • Recruiting
    • Department of Oncology, Aarhus University Hospital
    • Contact: Azza Khalil, MD, PhD; Phone Number: 004578465000; Email: azza.khalil@auh.rm.dk
    • Contact: Line Sparvath; Phone Number: 004578465000; Email: linspa@rm.dk
    • Principal Investigator: Katherina Farr, MD, PhD
    • Sub-Investigator: Azza Khalil, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	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 Measures

Outcome Measure	Measure Description	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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital; Westmead and Blacktown Hospital, Sydney West Radiation Oncology Network, Sydney, Australia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2020
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): December 1, 2024

Study Registration Dates

• First Submitted: December 15, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (ACTUAL): December 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 20, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: radiation-induced lung toxicity; functional avoidance methodology; radiation therapy of lung cancer
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Wounds and Injuries; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases, Interstitial; Lung Injury; Radiation Injuries; Lung Neoplasms; Pneumonia; Radiation Pneumonitis
• Other Study ID Numbers: KFE-1930

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No