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Functional Lung Avoidance SPECT-guided Radiation Therapy of Lung Cancer

RECRUITING

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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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2020-12-01

    Primary completion: 2023-12-01

    Study completion finish: 2024-12-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      NA

    trial

    Trial ID

    NCT04676828

    Intervention or treatment

    DIAGNOSTIC_TEST: Single-photon-emission CT scan

    Conditions

    • Lung Cancer
    • Radiation-Induced Disorder
    • Radiation Pneumonitis
    • Pulmonary Disease
    • Lung Function Decreased
    Image related to Lung Cancer
    • Condition: Lung Cancer, Radiation-Induced Disorder and more

    • DIAGNOSTIC_TEST: Single-photon-emission CT scan

    • Sydney, New South Wales, Australia

    • Sponsor: University of Aarhus

    Find a site

    Closest Location:

    Sydney West Radiation Oncology Network Westmead and Blacktown Hospitals

    Research sites nearby

    Select from list below to view details:

    • Sydney West Radiation Oncology Network Westmead and Blacktown Hospitals

      Sydney, New South Wales, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/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.
    Not specified

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Radiation-induced lung toxicitycrude 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

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Quality of lifeChange in quality of life according to the European Organisation for Research and Treatment of Cancer quality of life questionnairesMeasured serially from 1 to 12 months after treatment completion
    Patient reported lung symptomsChange in lung symptoms according to the European Organisation for Research and Treatment of Cancer questionnaireMeasured serially from 1 to 12 months after treatment completion
    Progression-free survivaltime from randomization to disease progression at any site or deathat 12 months
    Overall survivaltime from randomization to death of any cause or last date known aliveat 12 months
    Loco-regional control ratefreedom from local disease progressionat 12 months

    Frequently Asked Questions

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    References

    Clinical Trials Gov: Functional Lung Avoidance SPECT-guided Radiation Therapy of Lung Cancer

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