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 @ 5:50 PM
Ignite Modification Date:
2025-12-24 @ 5:50 PM
NCT ID:
NCT03267368
Eligibility Criteria:
Inclusion Criteria:
* Histologically proven diagnosis of non-small cell lung cancer (NSCLC), including the following types: squamous cell carcinoma, adenocarcinoma, large cell carcinoma, large cell neuroendocrine carcinoma, NSCLC not otherwise specified (NOS) \*Patients with large cell neuroendocrine tumors must have staging MRI of the brain (or CT with IV contrast if MRI contraindicated) due to the high rate of central nervous system (CNS) metastasis
* American Joint Committee on Cancer (AJCC) Lung 7th Edition clinical Stage T1-T2 N0 M0 with tumor less than or equal to 5 cm size
* Patient will undergo lung SBRT with curative intent
* Zubrod 0 - 2
* Patient evaluated by a Thoracic surgeon and deemed medically inoperable or borderline operable (candidate for only limited lung resection, either wedge resection or segmentectomy) within 8 weeks. For borderline operable patients, patient has seen both thoracic surgery and radiation oncology and has declined surgical intervention
* Baseline pulmonary function tests confirm that patient would medically qualify for Pulmonary Rehabilitation based on current guidelines. This means patient either has COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) II-IV or meets the non-COPD qualifying definition below (FVC, forced expiratory volume at one second (FEV1), or diffusing capacity of lung for carbon monoxide (DLCO) \< 65%) AND/OR patient is a current smoker (a non-COPD patient that is a smoker still has a modifiable risk factor; this will be a rare condition).
* Patient is at least 18 years of age
* Patient is a non-pregnant female and/or a female or male practicing adequate means of birth control
* Patient has either peripheral or central lung tumor location that is radiographically identifiable, with central locations as defined by either Radiation Therapy Oncology Group (RTOG) 0236 or RTOG 0813 criteria and will be likely to meet dose volume constraints for central mediastinal structures using one of the allowable dose fractionation schedule.
Exclusion Criteria:
* Patient has had a synchronous primary malignancy, including lung cancer within 2 years, excluding non-invasive cancers or early stage skin cancers
* Patient has had prior lung or thoracic radiotherapy, including prior lung SBRT
* Patient is planned to receive adjuvant systemic therapy for the management of this lung malignancy
* Does not own a functional mobile/cellular communication device (cellular phone, iPhone or iPad), or is not willing to incur any potential plan-specific additional charges
* Patients who cannot perform the prescribed rehabilitation and assessments
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03267368
Study Brief:
Protocol Section:
NCT03267368