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



Status:Completed
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/21/2018
Start Date:March 2012
End Date:January 16, 2018

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Phase I Study of Accelerated Hypofractionated Radiation Therapy With Concomitant Chemotherapy for Unresectable Stage III Non-Small Cell Lung Cancer

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.

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.

1. Histologically or cytologically documented non-small cell lung cancer

2. 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

3. Thoracic disease without supraclavicular or contralateral hilar involvement

4. 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

5. No prior radiotherapy or chemotherapy for NSCLC

6. No prior mediastinal or thoracic radiotherapy

7. 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

8. 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

9. Eastern Cooperative Oncology Group (ECOG) performance status 0-1

10. No patients that are known to be pregnant or nursing

11. 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
We found this trial at
11
sites
85 S Prospect St
Burlington, Vermont 5405
(802) 656-3131
University of Vermont The University of Vermont combines faculty-student relationships most commonly found in a...
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Burlington, VT
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Chapel Hill, NC
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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Providence, RI
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22 South Greene Street
Baltimore, Maryland 21201
410-328-7904
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
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Baltimore, MD
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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La Jolla, CA
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Phoenix, Arizona
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Phoenix, AZ
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5777 E Mayo Blvd
Scottsdale, Arizona 85259
(480) 515-6296
Mayo Clinic Scottsdale Mayo Clinic Arizona was the second Mayo practice to be established outside...
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Scottsdale, AZ
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Syracuse, NY
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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mi
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Winston-Salem, NC
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