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Recruiting NCT04676828

Functional Lung Avoidance SPECT-guided Radiation Therapy of Lung Cancer

No phase Interventional Lung Cancer Radiation-Induced Disorder Radiation Pneumonitis Pulmonary Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Single-photon-emission CT scan.
Who it may be relevant to
Registry conditions: Lung Cancer, Radiation-Induced Disorder, Radiation Pneumonitis, Pulmonary Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia, Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Radiation-induced lung toxicity [Time frame: Measured serially from 1 to 12 months after treatment completion]
Secondary outcome measures (5)
  • Quality of life [Time frame: Measured serially from 1 to 12 months after treatment completion]
  • Patient reported lung symptoms [Time frame: Measured serially from 1 to 12 months after treatment completion]
  • Progression-free survival [Time frame: at 12 months]
  • Overall survival [Time frame: at 12 months]
  • Loco-regional control rate [Time frame: at 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Australia · 1 center
  • Sydney West Radiation Oncology Network Westmead and Blacktown Hospitals — Sydney
Denmark · 1 center
  • Department of Oncology, Aarhus University Hospital — Aarhus

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. PMID 34418994

Identifiers

NCT: NCT04676828 · KFE-1930

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗