Spots Global Cancer Trial Database for Radiation Therapy Combined With Paclitaxel and Carboplatin in Treating Patients With Stage III Non-Small Cell Lung Cancer
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Trial Identification
Brief Title: Radiation Therapy Combined With Paclitaxel and Carboplatin in Treating Patients With Stage III Non-Small Cell Lung Cancer
Official Title: 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
Study ID: NCT00023673
Conditions
Study Description
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them with specialized radiation therapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the effectiveness of radiation therapy combined with paclitaxel and carboplatin in treating patients who have stage III non-small cell lung cancer.
Detailed Description: OBJECTIVES: * 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 01/13/04.) * 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 radiotherapy. * 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 de-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 highest dose at which no more than 1 patient experiences 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 (up to 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.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mobile Infirmary Medical Center, Mobile, Alabama, United States
Arizona Oncology Services Foundation, Phoenix, Arizona, United States
Providence Saint Joseph Medical Center - Burbank, Burbank, California, United States
Providence Holy Cross Cancer Center, Mission Hills, California, United States
University of California Davis Cancer Center, Sacramento, California, United States
Bay Medical, Panama City, Florida, United States
Northeast Georgia Medical Center, Gainesville, Georgia, United States
Saint Anthony's Hospital at Saint Anthony's Health Center, Alton, Illinois, United States
Alexian Brothers Radiation Oncology, Elk Grove Village, Illinois, United States
Good Samaritan Regional Health Center, Mount Vernon, Illinois, United States
Oncology Center at Saint Margaret Mercy Healthcare Center, Hammond, Indiana, United States
Cancer Center at Ball Memorial Hospital, Muncie, Indiana, United States
Regional Cancer Center at Singing River Hospital, Pascagoula, Mississippi, United States
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital, Cape Girardeau, Missouri, United States
Cancer Institute of Cape Girardeau, LLC, Cape Girardeau, Missouri, United States
Saint Francis Medical Center, Cape Girardeau, Missouri, United States
CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri, United States
David C. Pratt Cancer Center at St. John's Mercy, Saint Louis, Missouri, United States
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South, Springfield, Missouri, United States
Ocean Medical Center at Meridian Health, Brick, New Jersey, United States
J. Phillip Citta Regional Cancer Center at Community Medical Center, Toms River, New Jersey, United States
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare, Vineland, New Jersey, United States
CCOP - Hematology-Oncology Associates of Central New York, East Syracuse, New York, United States
High Point Regional Hospital, High Point, North Carolina, United States
Summa Center for Cancer Care at Akron City Hospital, Akron, Ohio, United States
Cleveland Clinic Cancer Center at Fairview Hospital, Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Cancer Treatment Center, Wooster, Ohio, United States
Three Rivers Community Hospital, Grants Pass, Oregon, United States
Dubs Cancer Center at Rogue Valley Medical Center, Medford, Oregon, United States
Providence Cancer Center at PMCC, Medford, Oregon, United States
Albert Einstein Cancer Center, Philadelphia, Pennsylvania, United States
Rapid City Regional Hospital, Rapid City, South Dakota, United States
University of Texas Medical Branch, Galveston, Texas, United States
Joe Arrington Cancer Research and Treatment Center, Lubbock, Texas, United States
Schiffler Cancer Center at Wheeling Hospital, Wheeling, West Virginia, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States
Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee, Milwaukee, Wisconsin, United States
Tom Baker Cancer Centre - Calgary, Calgary, Alberta, Canada
Contact Details
Name: Jeffrey Bradley, MD
Affiliation: Mallinckrodt Institute of Radiology at Washington University Medical Center
Role: STUDY_CHAIR
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