Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-24 @ 1:03 PM
NCT ID:
NCT02788461
Eligibility Criteria:
Inclusion Criteria:
* Patients who are at least 18 years old and are able to consent
* Patients who will undergo Chemo-RT as primarily modality of treatment
* Patients with a primary tumor or node measuring at least 10mm on CT scan
* Patients with a PET avid tumor having Standardized Uptake Values (SUV) \> 4
* Patients with Eastern Cooperative Oncology Group (ECOG) status 0-2 within 4 weeks of randomization
Exclusion Criteria:
* Trimodality patients who have surgery as part of curative treatment
* Previous radiotherapy to intended treatment volumes
* Active invasive malignancy other than lung cancer
* Active pregnancy
* Poor respiratory function (Forced Expiratory Volume \< 1.0 or Diffusing Capacity \< 50% age-adjusted normal)
* ECOG status \> 2
* Pre-treatment complete blood count/differential showing inadequate bone marrow reserve (absolute neutrophil count \< 1800 cells/mm3 or platelets \< 100 000 cells/mm3 or hemoglobin \< 90g/L), measured within 4 weeks of registration
* AST, ALT or total bilirubin \> 2.5 times the upper limit of normal, measured within 4 weeks of registration
* Unintentional weight loss \>10% over 3 months within 4 weeks of registration
* Severe active co-morbidity defined by:
* Significant history of uncontrolled cardiac disease; i.e. uncontrolled hypertension, unstable angina, myocardial infarction within the last 6 months, uncontrolled congestive heart failure, cardiomyopathy with decreased ejection fraction
* Transmural myocardial infection requiring intravenous antibiotics at the time of registration
* Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before randomization
* Acquired immune deficiency syndrome (AIDS) based on the current Centre for Disease Control definition; note, however, that HIV testing is not required for entry into this protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02788461
Study Brief:
Protocol Section:
NCT02788461