Status:
COMPLETED
Specialized Radiation Therapy and Chemotherapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial studies the side effects and the best dose of hypofractionated radiation therapy when given together with chemotherapy in treating patients with stage III non-small cell lung cancer...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the maximum-tolerable radiotherapy (RT) dose fraction for accelerated hypofractionated radiotherapy with concurrent chemotherapy. SECONDARY OBJECTIVES: I. To eva...
Eligibility Criteria
Inclusion
- Histologically or cytologically documented non-small cell lung cancer
- Stage IIIA or IIIB non-small cell lung cancer (NSCLC) per American Joint Committee on Cancer (AJCC) version 7; patients who present with N2 or N3 disease and an undetectable primary tumor are also eligible
- Thoracic disease without supraclavicular or contralateral hilar involvement
- When pleural fluid is visible on both computed tomography (CT) scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative; exudative pleural effusions are excluded regardless of cytology; patients with effusions that are minimal (i.e., not visible on chest x-ray) and too small to safely tap are eligible
- No prior radiotherapy or chemotherapy for NSCLC
- No prior mediastinal or thoracic radiotherapy
- Patients with complete surgical resection of disease are not eligible, however; patients with surgical resection and measurable gross residual disease present on imaging are considered eligible
- Patients must have measurable disease
- Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 2 cm with conventional techniques or as \>= 1 cm with spiral CT scan
- Patients with non-measurable disease are not eligible; all other lesions, including small lesions (longest diameter \< 20 mm with conventional techniques or \< 10 mm with spiral CT scan) and truly nonmeasurable lesions; lesions that are considered non-measurable include the following:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Inflammatory breast disease
- Lymphangitis cutis/pulmonis
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- No patients that are known to be pregnant or nursing
- Granulocytes ≥ 1,500/μl Platelet count ≥ 100,000/μl Bilirubin ≤ 1.5 times upper limit of normal (ULN) Aspartate aminotransferase (AST) (serum glutamic oxalo-acetic transaminase \[SGOT\]) ≤ 2.0 times ULN Serum creatinine ≤ 1.5 times ULN OR calculated creatinine clearance \>= 70 mL/min FEV-1 ≥ 1.2 L/sec or 50% predicted
Exclusion
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2018
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01486602
Start Date
March 1 2012
End Date
January 16 2018
Last Update
January 19 2018
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
2
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
3
Moores University of California San Diego Cancer Center
La Jolla, California, United States, 92093-0987
4
University of Chicago
Chicago, Illinois, United States, 60637