Image-Guided Functional Lung Avoidance Thoracic Radiotherapy for Lung Cancer: A Single-Blind Randomized Trial

Exclusion Criteria

• •1. Prior radiotherapy to thorax
• •2. Unable to receive assigned radiation dose due to normal lung constraint
• •3. Inability to attend full course of radiotherapy or follow-up visits
• •4. Presence of metastatic disease. Patients who present with oligo-metastatic disease where all metastases have been ablated (with surgery or radiotherapy) or in complete remission after systemic therapy are candidates if they are receiving radiotherapy to the thoracic disease with curative intent
• •5. Severe, active comorbidities which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events of the protocol, or limit compliance with study requirements, defined as follows:
• •* Uncontrolled active infection requiring intravenous antibiotics at the time of registration
• •* Transmural myocardial infarction ≤ 6 months prior to registration.
• •* Unstable angina or congestive heart failure requiring hospitalization ≤ 6 months prior to registration.
• •* Life-threatening uncontrolled clinically significant cardiac arrhythmias.
• •* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
• •* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration.
• •* Uncontrolled psychiatric disorder.
• •6. Women of childbearing potential and male participants who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the radiation treatment involved in this study may be significantly teratogenic.
• •7. Pregnant or lactating women