A Phase I/II Dose Intensification Study Using Three Dimensional Conformal Radiation Therapy And Concurrent Chemotherapy For Patients With Inoperable, Non-Small Cell Lung Cancer
- Determine the maximum tolerated dose of 3-dimensional conformal radiotherapy when
administered concurrently with paclitaxel and carboplatin in patients with inoperable
stage IIIA or IIIB non-small cell lung cancer. (Phase I) (Closed to accrual as of
- Determine the 12-month survival rate in patients treated with this regimen. (Phase II)
(Closed to accrual as of 11/27/07.)
- Determine the toxicity of this regimen in these patients.
- Determine the partial organ tolerance doses for the lung and esophagus in patients
treated with this regimen.
- Determine the complete response rate in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of 3-dimensional conformal
- Phase I (closed to accrual as of 01/13/04): Patients undergo 3-dimensional conformal
radiotherapy once daily five days a week for 7-8 weeks. Patients also receive
concurrent chemotherapy comprising paclitaxel IV over 1 hour followed by carboplatin IV
over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43.
Cohorts of 7-9 patients receive escalating doses of 3-dimensional conformal radiotherapy
until the maximum tolerated dose (MTD) is determined when given in combination with
chemotherapy. The MTD is defined as the dose preceding that at which 2 or more patients
experience dose-limiting toxicity.
- Phase II: Additional patients are accrued and treated as above at the MTD. At least 3
weeks after completing radiotherapy, patients may receive additional chemotherapy
comprising paclitaxel IV over 3 hours once and carboplatin IV over 30 minutes once.
Treatment with paclitaxel and carboplatin may repeat every 3 weeks for up to 2 courses.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months
for 3-5 years, and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 73 patients (27 for phase I [closed to accrual as of
10/28/04] and 46 for phase II) will be accrued for this study within 1-1.5 years.
Primary Purpose: Treatment
Maximum tolerated dose
Jeffrey Bradley, MD
Mallinckrodt Institute of Radiology at Washington University Medical Center
United States: Federal Government
|Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center||La Crosse, Wisconsin 54601|
|Medical College of Wisconsin Cancer Center||Milwaukee, Wisconsin 53226|
|Rapid City Regional Hospital||Rapid City, South Dakota 57709|
|Providence Saint Joseph Medical Center - Burbank||Burbank, California 91505|
|CCOP - Cancer Research for the Ozarks||Springfield, Missouri 65807|
|Albert Einstein Cancer Center||Philadelphia, Pennsylvania 19141|
|University of Texas Medical Branch||Galveston, Texas 77555-1329|
|Joe Arrington Cancer Research and Treatment Center||Lubbock, Texas 79410-1894|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|CCOP - St. Louis-Cape Girardeau||Saint Louis, Missouri 63141|
|University of California Davis Cancer Center||Sacramento, California 95817|
|Mobile Infirmary Medical Center||Mobile, Alabama 36640-0460|
|Hulston Cancer Center at Cox Medical Center South||Springfield, Missouri 65807|
|CCOP - Hematology-Oncology Associates of Central New York||East Syracuse, New York 13057|
|Saint Anthony's Hospital at Saint Anthony's Health Center||Alton, Illinois 62002|
|Good Samaritan Regional Health Center||Mt. Vernon, Illinois 62864|
|Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital||Gape Girardeau, Missouri 63701|
|David C. Pratt Cancer Center at St. John's Mercy||St. Louis, Missouri 63141|
|Cleveland Clinic Cancer Center at Fairview Hospital||Cleveland, Ohio 44111|
|Saint Francis Medical Center||Cape Girardeau, Missouri 63701|
|Providence Holy Cross Cancer Center||Mission Hills, California 91346-9600|
|Northeast Georgia Medical Center||Gainesville, Georgia 30501|
|Cancer Center at Ball Memorial Hospital||Muncie, Indiana 47303|
|Regional Cancer Center at Singing River Hospital||Pascagoula, Mississippi 39581|
|Cancer Treatment Center||Wooster, Ohio 44691|
|Summa Center for Cancer Care at Akron City Hospital||Akron, Ohio 44309-2090|
|Schiffler Cancer Center at Wheeling Hospital||Wheeling, West Virginia 26003|
|Arizona Oncology Services Foundation||Phoenix, Arizona 85013|
|Three Rivers Community Hospital||Grants Pass, Oregon 97527|
|Dubs Cancer Center at Rogue Valley Medical Center||Medford, Oregon 97504|
|Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare||Vineland, New Jersey 08360|
|Alexian Brothers Radiation Oncology||Elk Grove Village, Illinois 60007|
|Bay Medical||Panama City, Florida 32401|
|Oncology Center at Saint Margaret Mercy Healthcare Center||Hammond, Indiana 46320|
|Cancer Institute of Cape Girardeau, LLC||Cape Girardeau, Missouri 63703|
|Ocean Medical Center at Meridian Health||Brick, New Jersey 08724|
|J. Phillip Citta Regional Cancer Center at Community Medical Center||Toms River, New Jersey 08755|
|High Point Regional Hospital||High Point, North Carolina 27261|
|Providence Cancer Center at PMCC||Medford, Oregon 97504|
|Veterans Affairs Medical Center - Milwaukee||Milwaukee, Wisconsin 53295|