Functional Lung Avoidance SPECT-guided Radiation Therapy of Lung Cancer (ASPECT)

University of Aarhus

Status: Enrolling

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

Treatments: Diagnostic Test: Single-photon-emission CT scan

Study type: Interventional

Funder types: Other

Identifiers

NCT04676828

KFE-1930

Details and patient eligibility

About

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.

Full 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.

Enrollment: 195 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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195 participants in 2 patient groups

SPECT functional avoidance treatment

Experimental group

Description:

SPECT-based radiation therapy given taken functional distribution in the lung into account, that avoids highly functional lung volumes sparing them from radiation.

Treatment:

Diagnostic Test: Single-photon-emission CT scan

Standard treatment

No Intervention group

Description:

CT-based radiation therapy given over 5- 6.5 weeks.