SPECT-guided radiation that spares well-functioning lung during curative lung cancer treatment
Functional Lung Avoidance SPECT-guided (ASPECT) Radiation Therapy for Lung Cancer Patients: Phase II Randomised Clinical Trial
NA · University of Aarhus · NCT04676828
This trial will test whether using perfusion SPECT/CT to guide radiation plans that avoid highly functional lung reduces radiation-related lung damage for adults receiving curative chemo-radiation for lung cancer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus (other) |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 2 sites (Sydney, New South Wales and 1 other locations) |
| Trial ID | NCT04676828 on ClinicalTrials.gov |
What this trial studies
The trial uses perfusion SPECT/CT scans to map functional lung regions and create radiotherapy plans that spare highly functional lung tissue while delivering curative doses to the tumor. Adults with histologically confirmed small-cell or non-small-cell lung cancer referred for curative thoracic radiotherapy (including selected oligometastatic patients) will receive SPECT-guided planning, with concurrent chemotherapy allowed per site standard. Outcomes include incidence and severity of radiation-induced lung disease and pneumonitis, plus loco-regional control, time to progression, overall survival, quality of life, and radiation-induced molecular responses. Patients with prior thoracic radiotherapy or concurrent immunotherapy are excluded.
Who should consider this trial
Good fit: Adults with histologically confirmed small‑cell or non‑small‑cell lung cancer referred for curative-intent thoracic radiotherapy who can undergo SPECT/CT and provide informed consent are ideal candidates.
Not a fit: Patients with prior thoracic radiotherapy, those receiving concurrent immunotherapy, or with uncontrolled other malignancies or conditions that prevent following the protocol are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, this approach could reduce the frequency and severity of radiation-induced lung damage, improving breathing, quality of life, and the safety of curative treatment.
How similar studies have performed: Small pilot studies and dosimetric modeling have suggested functional lung avoidance can lower predicted lung dose and may reduce pulmonary toxicity, but robust prospective clinical evidence is still limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Sydney, New South Wales and 1 other locations
- Sydney West Radiation Oncology Network Westmead and Blacktown Hospitals — Sydney, New South Wales, Australia (RECRUITING)
- Department of Oncology, Aarhus University Hospital — Aarhus, Denmark (RECRUITING)
Study contacts
- Study coordinator: Katherina Farr, MD PhD FRACP
- Email: Katherina.Farr@health.nsw.gov.au
- Phone: +61 412695410
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lung Cancer, Radiation-Induced Disorder, Radiation Pneumonitis, Pulmonary Disease, Lung Function Decreased, radiation-induced lung toxicity, functional avoidance methodology, radiation therapy of lung cancer