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Spots Global Cancer Trial Database for Intensity-Modulated Radiation Therapy, Cisplatin, and Bevacizumab Followed by Carboplatin and Paclitaxel in Treating Patients Who Have Undergone Surgery for Endometrial Cancer

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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Akila Viswanathan

Affiliation: Radiation Therapy Oncology Group

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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