Intensity-Modulated Radiation Therapy to the Pelvis With or Without Chemotherapy in Treating Patients With Endometrial Cancer or Cervical Cancer That Has Been Removed By Surgery
1 февраля 2019 г. обновлено: Radiation Therapy Oncology Group
A Phase II Study of Intensity Modulated Radiation Therapy (IMRT) to the Pelvis ± Chemotherapy for Post-Operative Patients With Either Endometrial or Cervical Carcinoma
RATIONALE: Specialized radiation therapy (RT), such as intensity-modulated radiation therapy (IMRT), 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, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving intensity-modulated radiation therapy to the pelvis with or without chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well intensity-modulated radiation therapy to the pelvis with or without chemotherapy works in treating patients with endometrial cancer or cervical cancer that has been removed by surgery.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Подробное описание
OBJECTIVES:
- Determine the transportability of intensity modulated radiotherapy (IMRT) to a multi-institutional setting in patients with resected endometrial or cervical cancer.
- Compare the efficacy, in terms of reducing short-term bowel injury, of IMRT versus standard treatments.
- Assess adverse events related to this regimen.
- Estimate the rates of local-regional control, distant metastasis, and disease-free and overall survival.
- Evaluate chemotherapy compliance with this regimen for patients with cervical carcinoma.
OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (cervical vs endometrial cancer).
All patients undergo intensity modulated radiotherapy (IMRT) once a day, 5 days a week, for 5.5 weeks. Patients with cervical cancer also receive cisplatin IV over 30-60 minutes on day 1 or 2. Treatment with cisplatin repeats every 7 days for 5 courses (during radiotherapy) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 6 weeks post-IMRT and then every 3 months for 2 years, every 6 months for years 3-5, and then annually for at least 3 years.
PROJECTED ACCRUAL: A total of 92 patients will be accrued for this study.
Тип исследования
Интервенционный
Регистрация (Действительный)
106
Фаза
- Фаза 2
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Ontario
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Toronto, Ontario, Канада, M5G 2M9
- Princess Margaret Hospital
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Quebec
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Montreal, Quebec, Канада, H2W 1S6
- McGill Cancer Centre at McGill University
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California
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Auburn, California, Соединенные Штаты, 95603
- Auburn Radiation Oncology
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Cameron Park, California, Соединенные Штаты, 95682
- Radiation Oncology Centers - Cameron Park
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Carmichael, California, Соединенные Штаты, 95608
- Mercy Cancer Center at Mercy San Juan Medical Center
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Castro Valley, California, Соединенные Штаты, 94546
- East Bay Radiation Oncology Center
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Castro Valley, California, Соединенные Штаты, 94546
- Eden Medical Center
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Castro Valley, California, Соединенные Штаты, 94546
- Valley Medical Oncology Consultants - Castro Valley
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Duarte, California, Соединенные Штаты, 91010-3000
- City of Hope Comprehensive Cancer Center
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Fremont, California, Соединенные Штаты, 94538
- Valley Medical Oncology
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La Jolla, California, Соединенные Штаты, 92093-0658
- Rebecca and John Moores UCSD Cancer Center
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Oakland, California, Соединенные Штаты, 94609
- Alta Bates Summit Medical Center - Summit Campus
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Oakland, California, Соединенные Штаты, 94602
- Highland General Hospital
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Oakland, California, Соединенные Штаты, 94609
- Larry G Strieff MD Medical Corporation
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Oakland, California, Соединенные Штаты, 94609
- CCOP - Bay Area Tumor Institute
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Oakland, California, Соединенные Штаты, 94609
- Bay Area Breast Surgeons, Incorporated
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Oakland, California, Соединенные Штаты, 94609
- Tom K Lee, Incorporated
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Pleasanton, California, Соединенные Штаты, 94588
- Valley Care Medical Center
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Pleasanton, California, Соединенные Штаты, 94588
- Valley Medical Oncology Consultants - Pleasanton
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Roseville, California, Соединенные Штаты, 95661
- Radiation Oncology Center - Roseville
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Sacramento, California, Соединенные Штаты, 95815
- Radiological Associates of Sacramento Medical Group, Incorporated
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Sacramento, California, Соединенные Штаты, 95819
- Mercy General Hospital
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San Diego, California, Соединенные Штаты, 92161
- Veterans Affairs Medical Center - San Diego
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San Francisco, California, Соединенные Штаты, 94115
- UCSF Helen Diller Family Comprehensive Cancer Center
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San Pablo, California, Соединенные Штаты, 94806
- Doctors Medical Center - San Pablo Campus
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Vacaville, California, Соединенные Штаты, 95687
- Solano Radiation Oncology Center
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Delaware
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Lewes, Delaware, Соединенные Штаты, 19958
- Tunnell Cancer Center at Beebe Medical Center
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Newark, Delaware, Соединенные Штаты, 19713
- CCOP - Christiana Care Health Services
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Florida
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Jacksonville, Florida, Соединенные Штаты, 32224
- Mayo Clinic - Jacksonville
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Panama City, Florida, Соединенные Штаты, 32401
- Bay Medical
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Illinois
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Bloomington, Illinois, Соединенные Штаты, 61701
- St. Joseph Medical Center
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Canton, Illinois, Соединенные Штаты, 61520
- Graham Hospital
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Carthage, Illinois, Соединенные Штаты, 62321
- Memorial Hospital
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Chicago, Illinois, Соединенные Штаты, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
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Elk Grove Village, Illinois, Соединенные Штаты, 60007
- Alexian Brothers Radiation Oncology
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Eureka, Illinois, Соединенные Штаты, 61530
- Eureka Community Hospital
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Galesburg, Illinois, Соединенные Штаты, 61401
- Galesburg Cottage Hospital
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Galesburg, Illinois, Соединенные Штаты, 61401
- Galesburg Clinic, PC
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Galesburg, Illinois, Соединенные Штаты, 61401
- InterCommunity Cancer Center of Western Illinois
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Havana, Illinois, Соединенные Штаты, 62644
- Mason District Hospital
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Hopedale, Illinois, Соединенные Штаты, 61747
- Hopedale Medical Complex
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Macomb, Illinois, Соединенные Штаты, 61455
- Mcdonough District Hospital
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Maywood, Illinois, Соединенные Штаты, 60153
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
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Normal, Illinois, Соединенные Штаты, 61761
- Bromenn Regional Medical Center
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Normal, Illinois, Соединенные Штаты, 61761
- Community Cancer Center
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Olympia Fields, Illinois, Соединенные Штаты, 60461
- Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
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Ottawa, Illinois, Соединенные Штаты, 61350
- Community Hospital of Ottawa
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Ottawa, Illinois, Соединенные Штаты, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
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Pekin, Illinois, Соединенные Штаты, 61554
- Cancer Treatment Center at Pekin Hospital
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Peoria, Illinois, Соединенные Штаты, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Соединенные Штаты, 61614
- Proctor Hospital
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Peoria, Illinois, Соединенные Штаты, 61615
- CCOP - Illinois Oncology Research Association
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Peoria, Illinois, Соединенные Штаты, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peoria, Illinois, Соединенные Штаты, 61615-7827
- OSF St. Francis Medical Center
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Peru, Illinois, Соединенные Штаты, 61354
- Illinois Valley Community Hospital
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Princeton, Illinois, Соединенные Штаты, 61356
- Perry Memorial Hospital
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Spring Valley, Illinois, Соединенные Штаты, 61362
- St. Margaret's Hospital
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Spring Valley, Illinois, Соединенные Штаты, 61362
- Valley Cancer Center
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Springfield, Illinois, Соединенные Штаты, 62702
- Cancer Institute at St. John's Hospital
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Indiana
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Beech Grove, Indiana, Соединенные Штаты, 46107
- St. Francis Hospital and Health Centers - Beech Grove Campus
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Hammond, Indiana, Соединенные Штаты, 46320
- Oncology Center at Saint Margaret Mercy Healthcare Center
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Richmond, Indiana, Соединенные Штаты, 47374
- Reid Hospital & Health Care Services
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Iowa
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Iowa City, Iowa, Соединенные Штаты, 52242-1002
- Holden Comprehensive Cancer Center at University of Iowa
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Kansas
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Kansas City, Kansas, Соединенные Штаты, 66112
- Providence Medical Center
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Lawrence, Kansas, Соединенные Штаты, 66044
- Lawrence Memorial Hospital
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Overland Park, Kansas, Соединенные Штаты, 66209
- Menorah Medical Center
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Overland Park, Kansas, Соединенные Штаты, 66210
- Johnson County Radiation Therapy
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Shawnee Mission, Kansas, Соединенные Штаты, 66204
- Shawnee Mission Medical Center
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Maine
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Lewiston, Maine, Соединенные Штаты, 04240
- Central Maine Comprehensive Cancer Center at Central Maine Medical Center
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Maryland
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Elkton, Maryland, Соединенные Штаты, 21921
- Union Hospital Cancer Program at Union Hospital
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Massachusetts
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Boston, Massachusetts, Соединенные Штаты, 02115
- Dana-Farber/Brigham and Women's Cancer Center
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Quincy, Massachusetts, Соединенные Штаты, 02169
- South Suburban Oncology Center
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South Weymouth, Massachusetts, Соединенные Штаты, 02190
- South Shore Hospital
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Michigan
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Ann Arbor, Michigan, Соединенные Штаты, 48109-0942
- University of Michigan Comprehensive Cancer Center
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Detroit, Michigan, Соединенные Штаты, 48202
- Josephine Ford Cancer Center at Henry Ford Hospital
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Kalamazoo, Michigan, Соединенные Штаты, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, Соединенные Штаты, 49001
- Borgess Medical Center
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Kalamazoo, Michigan, Соединенные Штаты, 49007-3731
- West Michigan Cancer Center
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Minnesota
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Rochester, Minnesota, Соединенные Штаты, 55905
- Mayo Clinic Cancer Center
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Missouri
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Cape Girardeau, Missouri, Соединенные Штаты, 63703
- Cancer Institute of Cape Girardeau, LLC
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Independence, Missouri, Соединенные Штаты, 64050
- Independence Regional Health Center
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Kansas City, Missouri, Соединенные Штаты, 64131
- CCOP - Kansas City
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Kansas City, Missouri, Соединенные Штаты, 64116
- North Kansas City Hospital
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Kansas City, Missouri, Соединенные Штаты, 64132
- Research Medical Center
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Kansas City, Missouri, Соединенные Штаты, 64108
- Truman Medical Center - Hospital Hill
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Kansas City, Missouri, Соединенные Штаты, 64111
- Saint Luke's Cancer Institute at Saint Luke's Hospital
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Kansas City, Missouri, Соединенные Штаты, 64114
- St. Joseph Medical Center
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Kansas City, Missouri, Соединенные Штаты, 64116
- Parvin Radiation Oncology
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Kansas City, Missouri, Соединенные Штаты, 64114
- Kansas City Cancer Center at St. Joseph's Medical Mall
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Kansas City, Missouri, Соединенные Штаты, 64154
- Radiation Oncology Associates of Kansas City at Northland Radiation Oncology Center
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Saint Joseph, Missouri, Соединенные Штаты, 64506
- Heartland Regional Medical Center
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Springfield, Missouri, Соединенные Штаты, 65802
- CCOP - Cancer Research for the Ozarks
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Springfield, Missouri, Соединенные Штаты, 65804
- St. John's Regional Health Center
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Springfield, Missouri, Соединенные Штаты, 65807
- Hulston Cancer Center at Cox Medical Center South
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New Jersey
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Camden, New Jersey, Соединенные Штаты, 08103
- Cancer Institute of New Jersey at Cooper University Hospital - Camden
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Long Branch, New Jersey, Соединенные Штаты, 07740-6395
- Monmouth Medical Center
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New Brunswick, New Jersey, Соединенные Штаты, 08903
- Saint Peter's University Hospital
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Vineland, New Jersey, Соединенные Штаты, 08360
- Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
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Voorhees, New Jersey, Соединенные Штаты, 08043
- Cancer Institute of New Jersey at Cooper - Voorhees
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New Mexico
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Albuquerque, New Mexico, Соединенные Штаты, 87131-5636
- University of New Mexico Cancer Center
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Albuquerque, New Mexico, Соединенные Штаты, 87102
- Lovelace Medical Center - Downtown
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Albuquerque, New Mexico, Соединенные Штаты, 87109
- Radiation Oncology Associates, PA
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Santa Fe, New Mexico, Соединенные Штаты, 87505
- Cancer Institute of New Mexico
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New York
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Buffalo, New York, Соединенные Штаты, 14263-0001
- Roswell Park Cancer Institute
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New York, New York, Соединенные Штаты, 10025
- St. Luke's - Roosevelt Hospital Center - St.Luke's Division
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New York, New York, Соединенные Штаты, 10003-3803
- Beth Israel Medical Center - Petrie Division
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North Carolina
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Charlotte, North Carolina, Соединенные Штаты, 28233-3549
- Presbyterian Cancer Center at Presbyterian Hospital
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Ohio
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Akron, Ohio, Соединенные Штаты, 44307
- McDowell Cancer Center at Akron General Medical Center
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Akron, Ohio, Соединенные Штаты, 44309-2090
- Summa Center for Cancer Care at Akron City Hospital
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Cleveland, Ohio, Соединенные Штаты, 44106-5065
- Case Comprehensive Cancer Center
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Cleveland, Ohio, Соединенные Штаты, 44112
- Huron Hospital Cancer Care Center
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Cleveland, Ohio, Соединенные Штаты, 44119
- Euclid Hospital
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Dayton, Ohio, Соединенные Штаты, 45428
- Veterans Affairs Medical Center - Dayton
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Dayton, Ohio, Соединенные Штаты, 45405
- Grandview Hospital
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Dayton, Ohio, Соединенные Штаты, 45406
- Good Samaritan Hospital
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Dayton, Ohio, Соединенные Штаты, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
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Dayton, Ohio, Соединенные Штаты, 45415
- Samaritan North Cancer Care Center
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Dayton, Ohio, Соединенные Штаты, 45429
- CCOP - Dayton
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Findlay, Ohio, Соединенные Штаты, 45840
- Blanchard Valley Medical Associates
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Franklin, Ohio, Соединенные Штаты, 45005-1066
- Middletown Regional Hospital
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Kettering, Ohio, Соединенные Штаты, 45429
- Charles F. Kettering Memorial Hospital
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Mayfield Heights, Ohio, Соединенные Штаты, 44124
- Hillcrest Cancer Center at Hillcrest Hospital
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Salem, Ohio, Соединенные Штаты, 44460
- Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
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Troy, Ohio, Соединенные Штаты, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
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Warrensville Heights, Ohio, Соединенные Штаты, 44122
- South Pointe Hospital Cancer Care Center
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Wilmington, Ohio, Соединенные Штаты, 45177
- Clinton Memorial Hospital
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Wooster, Ohio, Соединенные Штаты, 44691
- Cancer Treatment Center
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Xenia, Ohio, Соединенные Штаты, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
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Pennsylvania
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Bryn Mawr, Pennsylvania, Соединенные Штаты, 19010
- Bryn Mawr Hospital
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Drexel Hill, Pennsylvania, Соединенные Штаты, 19026
- Delaware County Regional Cancer Center at Delaware County Memorial Hospital
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Paoli, Pennsylvania, Соединенные Штаты, 19301-1792
- Cancer Center of Paoli Memorial Hospital
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Wynnewood, Pennsylvania, Соединенные Штаты, 19096
- Lankenau Cancer Center at Lankenau Hospital
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Wynnewood, Pennsylvania, Соединенные Штаты, 19096
- CCOP - Main Line Health
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South Dakota
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Rapid City, South Dakota, Соединенные Штаты, 57701
- Rapid City Regional Hospital
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Tennessee
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Kingsport, Tennessee, Соединенные Штаты, 37662
- Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
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Texas
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Houston, Texas, Соединенные Штаты, 77030-4009
- M. D. Anderson Cancer Center at University of Texas
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Utah
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American Fork, Utah, Соединенные Штаты, 84003
- American Fork Hospital
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Cedar City, Utah, Соединенные Штаты, 84720
- Sandra L. Maxwell Cancer Center
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Murray, Utah, Соединенные Штаты, 84157
- Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
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Ogden, Utah, Соединенные Штаты, 84403
- Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
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Provo, Utah, Соединенные Штаты, 84604
- Utah Valley Regional Medical Center - Provo
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Saint George, Utah, Соединенные Штаты, 84770
- Dixie Regional Medical Center - East Campus
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Salt Lake City, Utah, Соединенные Штаты, 84112
- Huntsman Cancer Institute at University of Utah
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Salt Lake City, Utah, Соединенные Штаты, 84103
- LDS Hospital
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Salt Lake City, Utah, Соединенные Штаты, 84106
- Utah Cancer Specialists at UCS Cancer Center
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Vermont
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Burlington, Vermont, Соединенные Штаты, 05401
- Fletcher Allen Health Care - University Health Center Campus
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Virginia
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Norton, Virginia, Соединенные Штаты, 24273
- Southwest Virginia Regional Cancer Center at Wellmonth Health
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Washington
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Seattle, Washington, Соединенные Штаты, 98101
- CCOP - Virginia Mason Research Center
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Wisconsin
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La Crosse, Wisconsin, Соединенные Штаты, 54601
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
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Madison, Wisconsin, Соединенные Штаты, 53792-6164
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
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Mequon, Wisconsin, Соединенные Штаты, 53097
- Columbia Saint Mary's Hospital - Ozaukee
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Milwaukee, Wisconsin, Соединенные Штаты, 53211
- Columbia-Saint Mary's Cancer Care Center
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Wausau, Wisconsin, Соединенные Штаты, 54401
- University of Wisconcin Cancer Center at Aspirus Wausau Hospital
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Женский
Описание
DISEASE CHARACTERISTICS:
Must have undergone a hysterectomy (total abdominal, vaginal, radical, or laparoscopic-assisted vaginal) within 7 weeks prior to study entry
- Patients with endometrial cancer must have also undergone a bilateral salpingo-oophorectomy
Histologically confirmed diagnosis of 1 of the following:
Endometrial cancer meeting 1 of the following criteria:
- Stage IB grade 3, IC grade 1-3, IIA, or IIB disease requiring postoperative pelvic radiotherapy
- Unstaged (no lymph node dissection or sampling) stage IB grade 2 disease
Stage IIIC with all of the following:
- Pelvic lymph node positive only
- Para-aortic nodes sampled negative
- Not receiving chemotherapy
Cervical cancer meeting 1 of the following criteria:
Post-radical hysterectomy and requires postoperative pelvic radiotherapy due to any of the following:
- Positive pelvic nodes (negative para-aortic nodes)
- Microscopic parametrial involvement and negative margins
Disease qualified by Sedlis criteria must have 2 of the following risk factors:
- 1/3 or more stromal invasion
- Lymph-vascular space invasion
- Large clinical tumor diameter (≥ 4 cm)
- Post-simple hysterectomy with negative margins and negative nodes by CT scan, MRI, or positron emission tomography-CT scan
- No requirement for extended-field radiotherapy beyond the pelvis
- No histologically confirmed papillary serous, clear cell, or neuroendocrine (either large or small cell) disease, endometrial stromal sarcoma, leiomyosarcoma, or malignant müllerian mixed tumor
- No evidence of metastatic disease outside of the pelvis
- No microscopic involvement of the resection margin (< 3 mm)
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-2
- WBC (white blood cell count) ≥ 4,000/mm³ (cervical cancer patients only)
- Absolute neutrophil count ≥ 1,800/mm³ (cervical cancer patients only)
- Platelet count ≥ 100,000/mm³ (cervical cancer patients only)
- Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
- Serum creatinine ≤ 2.0 mg/dL (cervical cancer patients only)
- Creatinine clearance ≥ 50 mL/min (cervical cancer patients only)
- AST (aspartate aminotransferase) ≤ 2 times upper limit of normal
- Bilirubin ≤ 2 times upper limit of normal
Patients must not exceed the weight and size limits of the treatment table or CT scanner
- No mental status changes or bladder control problems that would preclude study compliance with bladder-filling instructions
- No active inflammatory bowel disease
No severe, active, concurrent illness, defined as any of the following:
- Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
- Transmural myocardial infarction within the past 6 months
- Acute bacterial or fungal infection requiring IV antibiotics
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- AIDS
- No history of allergy to cisplatin (cervical cancer patients)
- No prior invasive malignancy (except nonmelanoma skin cancer) unless disease-free for ≥ 3 years
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior radiotherapy to the pelvis that would result in overlap of radiotherapy fields
- No prior platinum-based chemotherapy (cervical cancer patients)
- No concurrent prophylactic growth factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], or pegfilgrastim)
- No concurrent prophylactic thrombopoietic agents
- No concurrent amifostine or other protective agents
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Другой: Endometrial Cancer: IMRT
Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT) 28 fractions over 5.5 weeks.
|
|
|
Другой: Cervical Cancer: IMRT + Chemotherapy (cisplatin)
Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) 28 fractions over 5.5 weeks and concurrent weekly cisplatin 40 mg/m^2 for five weeks.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Reproducibility of Radiation Technique (Number of Unacceptable Deviations in Central IMRT Quality Assurance Review)
Временное ограничение: IMRT planning and dosing data is centrally reviewed for quality assurance after treatment delivery.
|
Central quality assurance review of the IMRT planning and dosing categorized unacceptable deviations (UD) from protocol compliance with the delineation of planning target volume for the vagina and pelvic lymph nodes. Each arm of this study is considered independently, they are not compared to each other. The study was designed such that, for each arm, 5 or more of 42 subjects scored as unacceptable would determine the respective treatment technique as not reproducible. For each arm this design provides 90% power with a 0.05 type I error to reject the null hypothesis that the true probability of concluding the given technique to be reproducible is <= 80%. The alternative hypothesis is that the true probability is >= 95%. For [vagina / pelvic lymph nodes]: UD is defined as: The 90% isodose surface covers < 95% of [internal target volume (ITV)/ planned target volume (PTV)] 50.4 or > 5% of the [ITV/PTV] 50.4 receives over 115%. |
IMRT planning and dosing data is centrally reviewed for quality assurance after treatment delivery.
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Percentage of Patients With Grade 2+ Bowel Adverse Events
Временное ограничение: From the start of treatment to 90 days.
|
Bowel adverse events are defined as any of the following adverse events: diarrhea; enteritis; fistula; ileus:gastrointestinal (GI); incontinence:anal; necrosis:GI; obstruction:GI; perforation:GI; proctitis; stricture/stenosis (including anastomotic):GI.
Adverse events are graded using Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
Grade refers to the severity of the adverse event (AE).
The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to adverse event.
|
From the start of treatment to 90 days.
|
|
Percentage of Patients With Any Grade 3+ Treatment-related Adverse Events
Временное ограничение: From start of treatment to the end of follow-up. Maximum follow-up at time of analysis was 10.2 years for endometrium cancer patients and 9.5 years for cervical cancer patients.
|
Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
Grade refers to the severity of the adverse event (AE).
The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE.
|
From start of treatment to the end of follow-up. Maximum follow-up at time of analysis was 10.2 years for endometrium cancer patients and 9.5 years for cervical cancer patients.
|
|
Percentage of Patients With Any Late Grade 3+ Treatment-related Adverse Events
Временное ограничение: From 91 days after start of study treatment to the end of follow-up. Maximum follow-up at time of analysis was 10.2 years for endometrium cancer patients and 9.5 years for cervical cancer patients.
|
Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
Grade refers to the severity of the AE.
The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each adverse events (AE) based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE.
Late is defined as more than 90 days after the start of radiation therapy.
|
From 91 days after start of study treatment to the end of follow-up. Maximum follow-up at time of analysis was 10.2 years for endometrium cancer patients and 9.5 years for cervical cancer patients.
|
|
Percentage of Cervical Carcinoma Patients That Were Chemotherapy Compliant
Временное ограничение: From start to end of chemotherapy, approximately five weeks from registration.
|
Chemotherapy treatment was centrally reviewed for quality assurance and compliance once complete chemotherapy treatment data was received from sites.
|
From start to end of chemotherapy, approximately five weeks from registration.
|
|
Rate of Local-regional Failure at Five Years
Временное ограничение: From registration to five years.
|
Local-regional failure time is defined as time from registration to date of local-regional failure (any failure in the treatment field, which will be the pelvis only), death without local-regional failure (competing risk), or last known follow-up (censored).
Local-regional failure rates are estimated by the cumulative incidence method.
|
From registration to five years.
|
|
Rate of Distant Metastases at Five Years
Временное ограничение: From registration to five years
|
Distant Metastases failure time is defined as time from registration to date of distant disease, death without distant metastases (competing risk), or last known follow-up (censored) and is estimated by the cumulative incidence method.
Para-aortic nodal disease is considered to be distant disease for a cervical primary, but not for an endometrial primary.
|
From registration to five years
|
|
Rate of Disease-free Survival at Five Years
Временное ограничение: From registration five years
|
Disease-free survival time is defined as time from registration to date of failure (any tumor recurrence, development of distant metastases or death from any cause) and is estimated by the Kaplan-Meier method.
Patients last known to be alive without failure are censored at the date of last contact.
|
From registration five years
|
|
Rate of Overall Survival at Five Years
Временное ограничение: From randomization to five years
|
Overall survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier method.
Patients last known to be alive are censored at the date of last contact.
|
From randomization to five years
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Учебный стул: Anuja Jhingran, MD, M.D. Anderson Cancer Center
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 марта 2006 г.
Первичное завершение (Действительный)
1 февраля 2009 г.
Завершение исследования (Действительный)
1 декабря 2016 г.
Даты регистрации исследования
Первый отправленный
30 мая 2006 г.
Впервые представлено, что соответствует критериям контроля качества
30 мая 2006 г.
Первый опубликованный (Оценивать)
31 мая 2006 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
26 февраля 2019 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
1 февраля 2019 г.
Последняя проверка
1 февраля 2019 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
- плоскоклеточный рак шейки матки
- рак шейки матки IIB стадии
- IB стадия рака шейки матки
- рак шейки матки IIА стадии
- аденокарцинома шейки матки
- адено-плоскоклеточный рак шейки матки
- Рак эндометрия III стадии
- Рак эндометрия II стадии
- аденокарцинома эндометрия
- аденосквамозно-клеточная карцинома эндометрия
- I стадия рака эндометрия
- аденоакантома эндометрия
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- RTOG-0418
- CDR0000472905
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .