Lung Cancer Clinical Trial

Specialized Radiation Therapy and Chemotherapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

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 that cannot be removed by surgery. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving hypofractionated radiation therapy together with chemotherapy may kill more tumor cells.

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Full Description

PRIMARY OBJECTIVES:

I. To determine the maximum-tolerable radiotherapy (RT) dose fraction for accelerated hypofractionated radiotherapy with concurrent chemotherapy.

SECONDARY OBJECTIVES:

I. To evaluate the rate of radiographic response to treatment. II. To estimate the rates of progression: local/regional/distant. III. To estimate the progression-free survival. IV. To estimate the overall survival.

OUTLINE: This is a dose-escalation study of accelerated hypofractionated radiotherapy.

CONCURRENT THERAPY: Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30-60 minutes on days 1 and 8. Treatment repeats every 14 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo accelerated hypofractionated radiotherapy using 3-dimensional conformal radiation therapy or intensity-modulated radiotherapy (IMRT) once daily, 5 days a week, for approximately 4-5.5 weeks.

CONSOLIDATION THERAPY: Beginning 4 weeks after completion of radiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1 month, every 3 months for 2 years, and then every 6 months for 3 years.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

22

Study ID:

NCT01486602

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 11 Locations for this study

See Locations Near You

Mayo Clinic Hospital
Phoenix Arizona, 85054, United States
Mayo Clinic Scottsdale
Scottsdale Arizona, 85259, United States
Moores University of California San Diego Cancer Center
La Jolla California, 92093, United States
University of Chicago
Chicago Illinois, 60637, United States
University of Maryland/Greenebaum Cancer Center
Baltimore Maryland, 21201, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
State University of New York Upstate Medical University
Syracuse New York, 13210, United States
University of North Carolina - Chapel Hill
Chapel Hill North Carolina, 27599, United States
Wake Forest University Health Sciences
Winston-Salem North Carolina, 27157, United States
Rhode Island Hospital
Providence Rhode Island, 02903, United States
University of Vermont
Burlington Vermont, 05401, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

22

Study ID:

NCT01486602

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

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