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Brief Title: Intensity-Modulated Radiation Therapy, Cisplatin, and Bevacizumab Followed by Carboplatin and Paclitaxel in Treating Patients Who Have Undergone Surgery for Endometrial Cancer
Official Title: 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
Study ID: NCT01005329
Brief Summary: This phase II trial studies the side effects of giving intensity-modulated radiation therapy together with cisplatin and bevacizumab followed by carboplatin and cisplatin and to see how well they work in treating patients who have undergone surgery for high-risk endometrial cancer. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin, carboplatin, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving intensity-modulated radiation therapy together with chemotherapy and bevacizumab after surgery may kill any tumor cells that remain after surgery.
Detailed Description: 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: 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 intravenously (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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Alta Bates Summit Medical Center-Herrick Campus, Berkeley, California, United States
John Muir Medical Center-Walnut Creek, Walnut Creek, California, United States
Penrose-Saint Francis Healthcare, Colorado Springs, Colorado, United States
Poudre Valley Hospital, Fort Collins, Colorado, United States
Christiana Care Health System-Christiana Hospital, Newark, Delaware, United States
Integrated Community Oncology Network-Florida Cancer Center Beaches, Jacksonville Beach, Florida, United States
Baptist MD Anderson Cancer Center, Jacksonville, Florida, United States
Integrated Community Oncology Network-Southside Cancer Center, Jacksonville, Florida, United States
University of Florida Health Science Center - Jacksonville, Jacksonville, Florida, United States
Baptist Medical Center South, Jacksonville, Florida, United States
21st Century Oncology-Orange Park, Orange Park, Florida, United States
21st Century Oncology-Palatka, Palatka, Florida, United States
Bay Medical Center, Panama City, Florida, United States
Integrated Community Oncology Network-Flager Cancer Center, Saint Augustine, Florida, United States
Northwestern University, Chicago, Illinois, United States
John H Stroger Jr Hospital of Cook County, Chicago, Illinois, United States
Saint Vincent Anderson Regional Hospital/Cancer Center, Anderson, Indiana, United States
Saint Vincent Hospital and Health Care Center, Indianapolis, Indiana, United States
Kansas City NCI Community Oncology Research Program, Prairie Village, Kansas, United States
University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, United States
Central Maryland Radiation Oncology in Howard County, Columbia, Maryland, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
Henry Ford Hospital, Detroit, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Elliot Hospital, Manchester, New Hampshire, United States
Stony Brook University Medical Center, Stony Brook, New York, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
Summa Akron City Hospital/Cooper Cancer Center, Akron, Ohio, United States
Summa Barberton Hospital, Barberton, Ohio, United States
Flower Hospital, Sylvania, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Paoli Memorial Hospital, Paoli, Pennsylvania, United States
Radiation Therapy Oncology Group, Philadelphia, Pennsylvania, United States
Lankenau Medical Center, Wynnewood, Pennsylvania, United States
M D Anderson Cancer Center, Houston, Texas, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
Wheeling Hospital/Schiffler Cancer Center, Wheeling, West Virginia, United States
Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
London Regional Cancer Program, London, Ontario, Canada
McGill University Department of Oncology, Montreal, Quebec, Canada
Pamela Youde Nethersole Eastern Hospital, Chai Wan, , Hong Kong
Name: Akila Viswanathan
Affiliation: Radiation Therapy Oncology Group
Role: PRINCIPAL_INVESTIGATOR