Radiation Therapy Plus Celecoxib, Fluorouracil, and Cisplatin in Patients With Locally Advanced Cervical Cancer
- Conditions
- Cervical Cancer
- Registration Number
- NCT00023660
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy in different ways and combining it with chemotherapy may kill more tumor cells. Celecoxib may slow the growth of cervical cancer by stopping blood flow to the tumor.
PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy plus celecoxib, fluorouracil, and cisplatin in treating patients who have locally advanced cervical cancer.
- Detailed Description
OBJECTIVES:
* Determine treatment-related toxicity rates in patients with locally advanced cervical cancer treated with external beam radiotherapy and brachytherapy concurrently with celecoxib, fluorouracil, and cisplatin.
* Determine whether this regimen increases locoregional control rates, distant control, disease-free survival, and overall survival in these patients.
* Determine whether first-failure patterns in patients treated with this regimen are changed compared to historical controls.
OUTLINE: This is a multicenter study.
Patients undergo external beam pelvic radiotherapy once daily five days a weeks for 5 weeks beginning on day 1. Within 8 weeks, patients undergo low-dose or high-dose brachytherapy. Patients also receive concurrent chemotherapy comprising fluorouracil IV continuously over days 2-5, 23-26, and 44-47 and cisplatin IV over 4 hours on days 1, 22, and 43. Oral celecoxib is administered twice daily beginning on day 1 and continuing for 12 months.
Patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 83 patients will be accrued for this study within 1.5 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 84
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (36)
Akron General Medical Center
🇺🇸Akron, Ohio, United States
Akron City Hospital - Summa Health System
🇺🇸Akron, Ohio, United States
Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
CCOP - Marshfield Clinic Research Foundation
🇺🇸Marshfield, Wisconsin, United States
Bryn Mawr Hospital
🇺🇸Bryn Mawr, Pennsylvania, United States
Mercy Fitzgerald Hospital
🇺🇸Darby, Pennsylvania, United States
Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
LDS Hospital
🇺🇸Salt Lake City, Utah, United States
Community Medical Center
🇺🇸Toms River, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
🇺🇸Mount Holly, New Jersey, United States
South Jersey Regional Cancer Center
🇺🇸Millville, New Jersey, United States
Monmouth Medical Center
🇺🇸Long Branch, New Jersey, United States
Foundation for Cancer Research and Education
🇺🇸Phoenix, Arizona, United States
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
🇺🇸Omaha, Nebraska, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Sutter Health Western Division Cancer Research Group
🇺🇸Greenbrae, California, United States
Mills-Peninsula Health Services
🇺🇸Burlingame, California, United States
Memorial Hospital Cancer Center
🇺🇸Colorado Springs, Colorado, United States
Ball Memorial Hospital Cancer Center
🇺🇸Muncie, Indiana, United States
Regional Radiation Oncology Center at Rome
🇺🇸Rome, Georgia, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Delaware County Memorial Hospital
🇺🇸Drexel Hill, Pennsylvania, United States
Paoli Memorial Hospital
🇺🇸Paoli, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital
🇺🇸Wynnewood, Pennsylvania, United States
CCOP - MainLine Health
🇺🇸Wynnewood, Pennsylvania, United States
Dixie Regional Medical Center
🇺🇸Saint George, Utah, United States
State University of New York Health Science Center at Brooklyn
🇺🇸Brooklyn, New York, United States
New York Methodist Hospital
🇺🇸Brooklyn, New York, United States