Functional Lung Avoidance SPECT-guided Radiation Therapy of Lung Cancer

Study Overview
=================
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.

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

Conditions
-----------------
Lung Cancer, Radiation-Induced Disorder, Radiation Pneumonitis, Pulmonary Disease, Lung Function Decreased

Intervention / Treatment
-----------------
* Diagnostic Test: Single-photon-emission CT scan


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized double-blinded phase 2
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPECT functional avoidance treatment<br>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<br>* 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<br>|
| No Intervention: Standard treatment<br>CT-based radiation therapy given over 5- 6.5 weeks. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Measured serially from 1 to 12 months after treatment completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Change in quality of life according to the European Organisation for Research and Treatment of Cancer quality of life questionnaires | Measured serially from 1 to 12 months after treatment completion | 
| Patient reported lung symptoms | Change in lung symptoms according to the European Organisation for Research and Treatment of Cancer questionnaire | Measured serially from 1 to 12 months after treatment completion | 
| Progression-free survival | time from randomization to disease progression at any site or death | at 12 months | 
| Overall survival | time from randomization to death of any cause or last date known alive | at 12 months | 
| Loco-regional control rate | freedom from local disease progression | at 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radiation-induced lung toxicity, functional avoidance methodology, radiation therapy of lung cancer