A Phase II Study of Postoperative Intensity Modulated Radiation Therapy (IMRT) With Concurrent Cisplatin and Bevacizumab Followed by Carboplatin and Paclitaxel for Patients With Endometrial Cancer
PRIMARY OBJECTIVE:
I. To assess the treatment-related, grade 3+, non-hematologic adverse-event rate within 90
days from the start of treatment with concurrent intensity-modulated radiotherapy,
cisplatin, and bevacizumab followed by carboplatin and paclitaxel in patients with high-risk
endometrial cancer.
SECONDARY OBJECTIVES:
I. To evaluate treatment-related adverse events occurring within 1 year from the start of
treatment.
II. To evaluate all treatment-related adverse events. III. To evaluate disease-free and
overall survival. IV. To evaluate local, regional, and distant failure.
OUTLINE: This is a multicenter study.
Patients undergo pelvic intensity-modulated radiotherapy (IMRT) once daily, 5 days a week,
for 5 weeks. Patients may also undergo optional nodal boost radiotherapy and/or vaginal
brachytherapy boost. Patients also receive concurrent cisplatin IV over 1 hour on days 1 and
29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after
completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin IV over 1 hour and
paclitaxel IV over 3 hours on day 1. Treatment with carboplatin and paclitaxel repeats every
21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year,
every 6 months for 2 years, and then annually thereafter.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Treatment-related, grade 3+, non-hematologic adverse events as assessed by NCI CTCAE v4.0
Up to 90 days
Yes
Akila Viswanathan
Principal Investigator
American College of Radiology Imaging Network
United States: Food and Drug Administration
NCI-2011-01982
NCT01005329
November 2009
Name | Location |
---|---|
Akron City Hospital | Akron, Ohio 44304 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Henry Ford Hospital | Detroit, Michigan 48202 |
University of Florida Health Science Center | Gainesville, Florida 32610-0296 |
Bay Medical Center | Panama City, Florida 32401 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
John Muir Medical Center | Walnut Creek, California 94598 |
Brigham and Women's Hospital | Boston, Massachusetts 02115 |
Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
Poudre Valley Radiation Oncology | Fort Collins, Colorado 80528 |
Northwestern University | Chicago, Illinois 60611 |
Flower Hospital | Sylvania, Ohio 43560-2197 |
Huntsman Cancer Institute/University of Utah | Salt Lake City, Utah 84112 |
Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
M D Anderson Cancer Center | Houston, Texas 77030 |
Froedtert and the Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Wake Forest University Health Sciences | Winston-Salem, North Carolina 27157 |
Penrose-Saint Francis Healthcare | Colorado Springs, Colorado 80907 |
Edna Williams Cancer Center at the Baptist Cancer Institute | Jacksonville, Florida 32207 |
Elliot Hospital | Manchester, New Hampshire 03103 |
Summa Barberton Hospital | Barberton, Ohio 44203 |
Wheeling Hospital | Wheeling, West Virginia 26003 |
University of Maryland Greenebaum Cancer Center | Baltimore, Maryland 21201 |
Stony Brook University Medical Center | Stony Brook, New York 11794 |
Saint John's Health System Cancer Center | Anderson, Indiana 46016 |
Saint Vincent Oncology Center | Indianapolis, Indiana 46260 |
Alta Bates Summit Medical Center-Herrick Campus | Berkeley, California 94704 |
Christiana Care Health System-Christiana Hospital | Newark, Delaware 19718 |
Cancer Specialists of North Florida-Southside | Jacksonville, Florida 32207 |
Cancer Specialists of North Florida-Beaches | Jacksonville Beach, Florida 32250 |
Cancer Specialists of North Florida-Baptist South | Jascksonville, Florida 32258 |
Cancer Specialists of North Florida-Orange Park | Orange Park, Florida 32073 |
Cancer Specialists of North Florida-Putnam | Palatka, Florida 32177 |
Cancer Specialists of North Florida-Saint Augustine | Saint Augustine, Florida 32086 |
Central Maryland Radiation Oncology in Howard County | Columbia, Maryland 21044 |