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. února 2019 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
106
Fáze
- Fáze 2
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Ontario
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Toronto, Ontario, Kanada, M5G 2M9
- Princess Margaret Hospital
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Quebec
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Montreal, Quebec, Kanada, H2W 1S6
- McGill Cancer Centre at McGill University
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California
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Auburn, California, Spojené státy, 95603
- Auburn Radiation Oncology
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Cameron Park, California, Spojené státy, 95682
- Radiation Oncology Centers - Cameron Park
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Carmichael, California, Spojené státy, 95608
- Mercy Cancer Center at Mercy San Juan Medical Center
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Castro Valley, California, Spojené státy, 94546
- East Bay Radiation Oncology Center
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Castro Valley, California, Spojené státy, 94546
- Eden Medical Center
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Castro Valley, California, Spojené státy, 94546
- Valley Medical Oncology Consultants - Castro Valley
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Duarte, California, Spojené státy, 91010-3000
- City of Hope Comprehensive Cancer Center
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Fremont, California, Spojené státy, 94538
- Valley Medical Oncology
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La Jolla, California, Spojené státy, 92093-0658
- Rebecca and John Moores UCSD Cancer Center
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Oakland, California, Spojené státy, 94609
- Alta Bates Summit Medical Center - Summit Campus
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Oakland, California, Spojené státy, 94602
- Highland General Hospital
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Oakland, California, Spojené státy, 94609
- Larry G Strieff MD Medical Corporation
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Oakland, California, Spojené státy, 94609
- CCOP - Bay Area Tumor Institute
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Oakland, California, Spojené státy, 94609
- Bay Area Breast Surgeons, Incorporated
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Oakland, California, Spojené státy, 94609
- Tom K Lee, Incorporated
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Pleasanton, California, Spojené státy, 94588
- Valley Care Medical Center
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Pleasanton, California, Spojené státy, 94588
- Valley Medical Oncology Consultants - Pleasanton
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Roseville, California, Spojené státy, 95661
- Radiation Oncology Center - Roseville
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Sacramento, California, Spojené státy, 95815
- Radiological Associates of Sacramento Medical Group, Incorporated
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Sacramento, California, Spojené státy, 95819
- Mercy General Hospital
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San Diego, California, Spojené státy, 92161
- Veterans Affairs Medical Center - San Diego
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San Francisco, California, Spojené státy, 94115
- UCSF Helen Diller Family Comprehensive Cancer Center
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San Pablo, California, Spojené státy, 94806
- Doctors Medical Center - San Pablo Campus
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Vacaville, California, Spojené státy, 95687
- Solano Radiation Oncology Center
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Delaware
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Lewes, Delaware, Spojené státy, 19958
- Tunnell Cancer Center at Beebe Medical Center
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Newark, Delaware, Spojené státy, 19713
- CCOP - Christiana Care Health Services
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Florida
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Jacksonville, Florida, Spojené státy, 32224
- Mayo Clinic - Jacksonville
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Panama City, Florida, Spojené státy, 32401
- Bay Medical
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Illinois
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Bloomington, Illinois, Spojené státy, 61701
- St. Joseph Medical Center
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Canton, Illinois, Spojené státy, 61520
- Graham Hospital
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Carthage, Illinois, Spojené státy, 62321
- Memorial Hospital
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Chicago, Illinois, Spojené státy, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
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Elk Grove Village, Illinois, Spojené státy, 60007
- Alexian Brothers Radiation Oncology
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Eureka, Illinois, Spojené státy, 61530
- Eureka Community Hospital
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Galesburg, Illinois, Spojené státy, 61401
- Galesburg Cottage Hospital
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Galesburg, Illinois, Spojené státy, 61401
- Galesburg Clinic, PC
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Galesburg, Illinois, Spojené státy, 61401
- InterCommunity Cancer Center of Western Illinois
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Havana, Illinois, Spojené státy, 62644
- Mason District Hospital
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Hopedale, Illinois, Spojené státy, 61747
- Hopedale Medical Complex
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Macomb, Illinois, Spojené státy, 61455
- Mcdonough District Hospital
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Maywood, Illinois, Spojené státy, 60153
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
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Normal, Illinois, Spojené státy, 61761
- Bromenn Regional Medical Center
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Normal, Illinois, Spojené státy, 61761
- Community Cancer Center
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Olympia Fields, Illinois, Spojené státy, 60461
- Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
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Ottawa, Illinois, Spojené státy, 61350
- Community Hospital of Ottawa
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Ottawa, Illinois, Spojené státy, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
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Pekin, Illinois, Spojené státy, 61554
- Cancer Treatment Center at Pekin Hospital
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Peoria, Illinois, Spojené státy, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Spojené státy, 61614
- Proctor Hospital
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Peoria, Illinois, Spojené státy, 61615
- CCOP - Illinois Oncology Research Association
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Peoria, Illinois, Spojené státy, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peoria, Illinois, Spojené státy, 61615-7827
- OSF St. Francis Medical Center
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Peru, Illinois, Spojené státy, 61354
- Illinois Valley Community Hospital
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Princeton, Illinois, Spojené státy, 61356
- Perry Memorial Hospital
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Spring Valley, Illinois, Spojené státy, 61362
- St. Margaret's Hospital
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Spring Valley, Illinois, Spojené státy, 61362
- Valley Cancer Center
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Springfield, Illinois, Spojené státy, 62702
- Cancer Institute at St. John's Hospital
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Indiana
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Beech Grove, Indiana, Spojené státy, 46107
- St. Francis Hospital and Health Centers - Beech Grove Campus
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Hammond, Indiana, Spojené státy, 46320
- Oncology Center at Saint Margaret Mercy Healthcare Center
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Richmond, Indiana, Spojené státy, 47374
- Reid Hospital & Health Care Services
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Iowa
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Iowa City, Iowa, Spojené státy, 52242-1002
- Holden Comprehensive Cancer Center at University of Iowa
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Kansas
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Kansas City, Kansas, Spojené státy, 66112
- Providence Medical Center
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Lawrence, Kansas, Spojené státy, 66044
- Lawrence Memorial Hospital
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Overland Park, Kansas, Spojené státy, 66209
- Menorah Medical Center
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Overland Park, Kansas, Spojené státy, 66210
- Johnson County Radiation Therapy
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Shawnee Mission, Kansas, Spojené státy, 66204
- Shawnee Mission Medical Center
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Maine
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Lewiston, Maine, Spojené státy, 04240
- Central Maine Comprehensive Cancer Center at Central Maine Medical Center
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Maryland
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Elkton, Maryland, Spojené státy, 21921
- Union Hospital Cancer Program at Union Hospital
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02115
- Dana-Farber/Brigham and Women's Cancer Center
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Quincy, Massachusetts, Spojené státy, 02169
- South Suburban Oncology Center
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South Weymouth, Massachusetts, Spojené státy, 02190
- South Shore Hospital
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Michigan
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Ann Arbor, Michigan, Spojené státy, 48109-0942
- University of Michigan Comprehensive Cancer Center
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Detroit, Michigan, Spojené státy, 48202
- Josephine Ford Cancer Center at Henry Ford Hospital
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Kalamazoo, Michigan, Spojené státy, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, Spojené státy, 49001
- Borgess Medical Center
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Kalamazoo, Michigan, Spojené státy, 49007-3731
- West Michigan Cancer Center
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Minnesota
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Rochester, Minnesota, Spojené státy, 55905
- Mayo Clinic Cancer Center
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Missouri
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Cape Girardeau, Missouri, Spojené státy, 63703
- Cancer Institute of Cape Girardeau, LLC
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Independence, Missouri, Spojené státy, 64050
- Independence Regional Health Center
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Kansas City, Missouri, Spojené státy, 64131
- CCOP - Kansas City
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Kansas City, Missouri, Spojené státy, 64116
- North Kansas City Hospital
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Kansas City, Missouri, Spojené státy, 64132
- Research Medical Center
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Kansas City, Missouri, Spojené státy, 64108
- Truman Medical Center - Hospital Hill
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Kansas City, Missouri, Spojené státy, 64111
- Saint Luke's Cancer Institute at Saint Luke's Hospital
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Kansas City, Missouri, Spojené státy, 64114
- St. Joseph Medical Center
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Kansas City, Missouri, Spojené státy, 64116
- Parvin Radiation Oncology
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Kansas City, Missouri, Spojené státy, 64114
- Kansas City Cancer Center at St. Joseph's Medical Mall
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Kansas City, Missouri, Spojené státy, 64154
- Radiation Oncology Associates of Kansas City at Northland Radiation Oncology Center
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Saint Joseph, Missouri, Spojené státy, 64506
- Heartland Regional Medical Center
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Springfield, Missouri, Spojené státy, 65802
- CCOP - Cancer Research for the Ozarks
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Springfield, Missouri, Spojené státy, 65804
- St. John's Regional Health Center
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Springfield, Missouri, Spojené státy, 65807
- Hulston Cancer Center at Cox Medical Center South
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New Jersey
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Camden, New Jersey, Spojené státy, 08103
- Cancer Institute of New Jersey at Cooper University Hospital - Camden
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Long Branch, New Jersey, Spojené státy, 07740-6395
- Monmouth Medical Center
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New Brunswick, New Jersey, Spojené státy, 08903
- Saint Peter's University Hospital
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Vineland, New Jersey, Spojené státy, 08360
- Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
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Voorhees, New Jersey, Spojené státy, 08043
- Cancer Institute of New Jersey at Cooper - Voorhees
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New Mexico
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Albuquerque, New Mexico, Spojené státy, 87131-5636
- University of New Mexico Cancer Center
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Albuquerque, New Mexico, Spojené státy, 87102
- Lovelace Medical Center - Downtown
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Albuquerque, New Mexico, Spojené státy, 87109
- Radiation Oncology Associates, PA
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Santa Fe, New Mexico, Spojené státy, 87505
- Cancer Institute of New Mexico
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New York
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Buffalo, New York, Spojené státy, 14263-0001
- Roswell Park Cancer Institute
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New York, New York, Spojené státy, 10025
- St. Luke's - Roosevelt Hospital Center - St.Luke's Division
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New York, New York, Spojené státy, 10003-3803
- Beth Israel Medical Center - Petrie Division
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North Carolina
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Charlotte, North Carolina, Spojené státy, 28233-3549
- Presbyterian Cancer Center at Presbyterian Hospital
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Ohio
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Akron, Ohio, Spojené státy, 44307
- McDowell Cancer Center at Akron General Medical Center
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Akron, Ohio, Spojené státy, 44309-2090
- Summa Center for Cancer Care at Akron City Hospital
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Cleveland, Ohio, Spojené státy, 44106-5065
- Case Comprehensive Cancer Center
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Cleveland, Ohio, Spojené státy, 44112
- Huron Hospital Cancer Care Center
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Cleveland, Ohio, Spojené státy, 44119
- Euclid Hospital
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Dayton, Ohio, Spojené státy, 45428
- Veterans Affairs Medical Center - Dayton
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Dayton, Ohio, Spojené státy, 45405
- Grandview Hospital
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Dayton, Ohio, Spojené státy, 45406
- Good Samaritan Hospital
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Dayton, Ohio, Spojené státy, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
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Dayton, Ohio, Spojené státy, 45415
- Samaritan North Cancer Care Center
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Dayton, Ohio, Spojené státy, 45429
- CCOP - Dayton
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Findlay, Ohio, Spojené státy, 45840
- Blanchard Valley Medical Associates
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Franklin, Ohio, Spojené státy, 45005-1066
- Middletown Regional Hospital
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Kettering, Ohio, Spojené státy, 45429
- Charles F. Kettering Memorial Hospital
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Mayfield Heights, Ohio, Spojené státy, 44124
- Hillcrest Cancer Center at Hillcrest Hospital
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Salem, Ohio, Spojené státy, 44460
- Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
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Troy, Ohio, Spojené státy, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
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Warrensville Heights, Ohio, Spojené státy, 44122
- South Pointe Hospital Cancer Care Center
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Wilmington, Ohio, Spojené státy, 45177
- Clinton Memorial Hospital
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Wooster, Ohio, Spojené státy, 44691
- Cancer Treatment Center
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Xenia, Ohio, Spojené státy, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
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Pennsylvania
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Bryn Mawr, Pennsylvania, Spojené státy, 19010
- Bryn Mawr Hospital
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Drexel Hill, Pennsylvania, Spojené státy, 19026
- Delaware County Regional Cancer Center at Delaware County Memorial Hospital
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Paoli, Pennsylvania, Spojené státy, 19301-1792
- Cancer Center of Paoli Memorial Hospital
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Wynnewood, Pennsylvania, Spojené státy, 19096
- Lankenau Cancer Center at Lankenau Hospital
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Wynnewood, Pennsylvania, Spojené státy, 19096
- CCOP - Main Line Health
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South Dakota
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Rapid City, South Dakota, Spojené státy, 57701
- Rapid City Regional Hospital
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Tennessee
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Kingsport, Tennessee, Spojené státy, 37662
- Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
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Texas
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Houston, Texas, Spojené státy, 77030-4009
- M. D. Anderson Cancer Center at University of Texas
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Utah
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American Fork, Utah, Spojené státy, 84003
- American Fork Hospital
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Cedar City, Utah, Spojené státy, 84720
- Sandra L. Maxwell Cancer Center
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Murray, Utah, Spojené státy, 84157
- Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
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Ogden, Utah, Spojené státy, 84403
- Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
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Provo, Utah, Spojené státy, 84604
- Utah Valley Regional Medical Center - Provo
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Saint George, Utah, Spojené státy, 84770
- Dixie Regional Medical Center - East Campus
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Salt Lake City, Utah, Spojené státy, 84112
- Huntsman Cancer Institute at University of Utah
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Salt Lake City, Utah, Spojené státy, 84103
- LDS Hospital
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Salt Lake City, Utah, Spojené státy, 84106
- Utah Cancer Specialists at UCS Cancer Center
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Vermont
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Burlington, Vermont, Spojené státy, 05401
- Fletcher Allen Health Care - University Health Center Campus
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Virginia
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Norton, Virginia, Spojené státy, 24273
- Southwest Virginia Regional Cancer Center at Wellmonth Health
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Washington
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Seattle, Washington, Spojené státy, 98101
- CCOP - Virginia Mason Research Center
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Wisconsin
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La Crosse, Wisconsin, Spojené státy, 54601
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
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Madison, Wisconsin, Spojené státy, 53792-6164
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
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Mequon, Wisconsin, Spojené státy, 53097
- Columbia Saint Mary's Hospital - Ozaukee
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Milwaukee, Wisconsin, Spojené státy, 53211
- Columbia-Saint Mary's Cancer Care Center
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Wausau, Wisconsin, Spojené státy, 54401
- University of Wisconcin Cancer Center at Aspirus Wausau Hospital
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Ženský
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Jiný: Endometrial Cancer: IMRT
Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT) 28 fractions over 5.5 weeks.
|
|
|
Jiný: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Reproducibility of Radiation Technique (Number of Unacceptable Deviations in Central IMRT Quality Assurance Review)
Časové okno: 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.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Percentage of Patients With Grade 2+ Bowel Adverse Events
Časové okno: 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
Časové okno: 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
Časové okno: 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.
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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.
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Percentage of Cervical Carcinoma Patients That Were Chemotherapy Compliant
Časové okno: From start to end of chemotherapy, approximately five weeks from registration.
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Chemotherapy treatment was centrally reviewed for quality assurance and compliance once complete chemotherapy treatment data was received from sites.
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From start to end of chemotherapy, approximately five weeks from registration.
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Rate of Local-regional Failure at Five Years
Časové okno: From registration to five years.
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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.
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From registration to five years.
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Rate of Distant Metastases at Five Years
Časové okno: From registration to five years
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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.
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From registration to five years
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Rate of Disease-free Survival at Five Years
Časové okno: From registration five years
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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.
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From registration five years
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Rate of Overall Survival at Five Years
Časové okno: From randomization to five years
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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.
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From randomization to five years
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Studijní židle: Anuja Jhingran, MD, M.D. Anderson Cancer Center
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. března 2006
Primární dokončení (Aktuální)
1. února 2009
Dokončení studie (Aktuální)
1. prosince 2016
Termíny zápisu do studia
První předloženo
30. května 2006
První předloženo, které splnilo kritéria kontroly kvality
30. května 2006
První zveřejněno (Odhad)
31. května 2006
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
26. února 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
1. února 2019
Naposledy ověřeno
1. února 2019
Více informací
Termíny související s touto studií
Klíčová slova
- spinocelulárního karcinomu děložního čípku
- stadia IIB rakoviny děložního čípku
- rakovina děložního čípku stadia IB
- rakovina děložního čípku stadia IIA
- cervikální adenokarcinom
- cervikální adenoskvamocelulární karcinom
- stadium III karcinomu endometria
- stadium II karcinomu endometria
- adenokarcinom endometria
- endometriální adenoskvamocelulární karcinom
- stadium I karcinomu endometria
- adenoakantom endometria
Další relevantní podmínky MeSH
Další identifikační čísla studie
- RTOG-0418
- CDR0000472905
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .