Functional Lung Avoidance SPECT-guided Radiation Therapy of Lung Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Aarhus

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

concurrent immunotherapy

previous radiotherapy to the thorax

other uncontrolled malignancies; any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: SPECT functional avoidance treatmentExperimental treatment 1 intervention
Group B: Standard treatmentNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Measured serially from 1 to 12 months after treatment completion

Secondary outcomes

1

Quality of life

Change in quality of life according to the European Organisation for Research and Treatment of Cancer quality of life questionnaires

Time frame
Measured serially from 1 to 12 months after treatment completion
2

Patient reported lung symptoms

Change in lung symptoms according to the European Organisation for Research and Treatment of Cancer questionnaire

Time frame
Measured serially from 1 to 12 months after treatment completion
3

Progression-free survival

time from randomization to disease progression at any site or death

Time frame
at 12 months
4

Overall survival

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

Time frame
at 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Aarhus

Lead sponsor

Aarhus University Hospital

Sponsor institution

Westmead and Blacktown Hospital, Sydney West Radiation Oncology Network, Sydney, Australia

Collaborator

Aarhus University Hospital

Collaborator

South Eastern Sydney Local Health District

Collaborator

The University of New South Wales

Collaborator

Northern NSW Local Health District, NSW Australia

Collaborator