Status:
TERMINATED
Comprehensive Care Program SBRT
Lead Sponsor:
Corewell Health East
Conditions:
Lung Cancer
Smoking
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Pulmonary (lung) rehabilitation, which is done under the guidance of lung specialists/therapists. It includes breathing exercises, physical exercises, and exercises to increase tolerance of activity (...
Detailed Description
Primary objective: To evaluate the technical feasibility and delivery of a comprehensive program that leads to prevention and management of symptoms of COPD in early stage lung cancer patients undergo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2018
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03267368
Start Date
September 11 2017
End Date
May 23 2018
Last Update
April 13 2020
Active Locations (2)
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1
Beaumont Health System
Royal Oak, Michigan, United States, 48073
2
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073