Clinical trial NCT04676828: Functional Lung Avoidance SPECT-guided Radiation Therapy of Lung Cancer
Official title: Functional Lung Avoidance SPECT-guided (ASPECT) Radiation Therapy for Lung Cancer Patients: Phase II Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Radiation-Induced Disorder
Radiation Pneumonitis
Pulmonary Disease
Lung Function Decreased
Keywords: radiation-induced lung toxicity
functional avoidance methodology
radiation therapy of lung cancer
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Westmead and Blacktown Hospital, Sydney West Radiation Oncology Network, Sydney, Australia
name: Aarhus University Hospital
First posted: 2020-12-21
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized double-blinded phase 2
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Radiation-induced lung toxicity
timeFrame: Measured serially from 1 to 12 months after treatment completion
Secondary outcomes:
measure: Quality of life
timeFrame: Measured serially from 1 to 12 months after treatment completion
measure: Patient reported lung symptoms
timeFrame: Measured serially from 1 to 12 months after treatment completion
measure: Progression-free survival
timeFrame: at 12 months
measure: Overall survival
timeFrame: at 12 months
measure: Loco-regional control rate
timeFrame: at 12 months
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Sydney West Radiation Oncology Network Westmead and Blacktown Hospitals
state: New South Wales
city: Aarhus
country: Denmark
facility: Department of Oncology, Aarhus University Hospital
Study officials:
References:
citation: 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.