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. februar 2019 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
106
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
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Quebec
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Montreal, Quebec, Canada, H2W 1S6
- McGill Cancer Centre at McGill University
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California
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Auburn, California, Forenede Stater, 95603
- Auburn Radiation Oncology
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Cameron Park, California, Forenede Stater, 95682
- Radiation Oncology Centers - Cameron Park
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Carmichael, California, Forenede Stater, 95608
- Mercy Cancer Center at Mercy San Juan Medical Center
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Castro Valley, California, Forenede Stater, 94546
- East Bay Radiation Oncology Center
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Castro Valley, California, Forenede Stater, 94546
- Eden Medical Center
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Castro Valley, California, Forenede Stater, 94546
- Valley Medical Oncology Consultants - Castro Valley
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Duarte, California, Forenede Stater, 91010-3000
- City of Hope Comprehensive Cancer Center
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Fremont, California, Forenede Stater, 94538
- Valley Medical Oncology
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La Jolla, California, Forenede Stater, 92093-0658
- Rebecca and John Moores UCSD Cancer Center
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Oakland, California, Forenede Stater, 94609
- Alta Bates Summit Medical Center - Summit Campus
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Oakland, California, Forenede Stater, 94602
- Highland General Hospital
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Oakland, California, Forenede Stater, 94609
- Larry G Strieff MD Medical Corporation
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Oakland, California, Forenede Stater, 94609
- CCOP - Bay Area Tumor Institute
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Oakland, California, Forenede Stater, 94609
- Bay Area Breast Surgeons, Incorporated
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Oakland, California, Forenede Stater, 94609
- Tom K Lee, Incorporated
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Pleasanton, California, Forenede Stater, 94588
- Valley Care Medical Center
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Pleasanton, California, Forenede Stater, 94588
- Valley Medical Oncology Consultants - Pleasanton
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Roseville, California, Forenede Stater, 95661
- Radiation Oncology Center - Roseville
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Sacramento, California, Forenede Stater, 95815
- Radiological Associates of Sacramento Medical Group, Incorporated
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Sacramento, California, Forenede Stater, 95819
- Mercy General Hospital
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San Diego, California, Forenede Stater, 92161
- Veterans Affairs Medical Center - San Diego
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San Francisco, California, Forenede Stater, 94115
- UCSF Helen Diller Family Comprehensive Cancer Center
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San Pablo, California, Forenede Stater, 94806
- Doctors Medical Center - San Pablo Campus
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Vacaville, California, Forenede Stater, 95687
- Solano Radiation Oncology Center
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Delaware
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Lewes, Delaware, Forenede Stater, 19958
- Tunnell Cancer Center at Beebe Medical Center
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Newark, Delaware, Forenede Stater, 19713
- CCOP - Christiana Care Health Services
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Florida
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Jacksonville, Florida, Forenede Stater, 32224
- Mayo Clinic - Jacksonville
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Panama City, Florida, Forenede Stater, 32401
- Bay Medical
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Illinois
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Bloomington, Illinois, Forenede Stater, 61701
- St. Joseph Medical Center
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Canton, Illinois, Forenede Stater, 61520
- Graham Hospital
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Carthage, Illinois, Forenede Stater, 62321
- Memorial Hospital
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Chicago, Illinois, Forenede Stater, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
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Elk Grove Village, Illinois, Forenede Stater, 60007
- Alexian Brothers Radiation Oncology
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Eureka, Illinois, Forenede Stater, 61530
- Eureka Community Hospital
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Galesburg, Illinois, Forenede Stater, 61401
- Galesburg Cottage Hospital
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Galesburg, Illinois, Forenede Stater, 61401
- Galesburg Clinic, PC
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Galesburg, Illinois, Forenede Stater, 61401
- InterCommunity Cancer Center of Western Illinois
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Havana, Illinois, Forenede Stater, 62644
- Mason District Hospital
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Hopedale, Illinois, Forenede Stater, 61747
- Hopedale Medical Complex
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Macomb, Illinois, Forenede Stater, 61455
- Mcdonough District Hospital
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Maywood, Illinois, Forenede Stater, 60153
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
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Normal, Illinois, Forenede Stater, 61761
- Bromenn Regional Medical Center
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Normal, Illinois, Forenede Stater, 61761
- Community Cancer Center
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Olympia Fields, Illinois, Forenede Stater, 60461
- Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
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Ottawa, Illinois, Forenede Stater, 61350
- Community Hospital of Ottawa
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Ottawa, Illinois, Forenede Stater, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
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Pekin, Illinois, Forenede Stater, 61554
- Cancer Treatment Center at Pekin Hospital
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Peoria, Illinois, Forenede Stater, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Forenede Stater, 61614
- Proctor Hospital
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Peoria, Illinois, Forenede Stater, 61615
- CCOP - Illinois Oncology Research Association
-
Peoria, Illinois, Forenede Stater, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peoria, Illinois, Forenede Stater, 61615-7827
- OSF St. Francis Medical Center
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Peru, Illinois, Forenede Stater, 61354
- Illinois Valley Community Hospital
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Princeton, Illinois, Forenede Stater, 61356
- Perry Memorial Hospital
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Spring Valley, Illinois, Forenede Stater, 61362
- St. Margaret's Hospital
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Spring Valley, Illinois, Forenede Stater, 61362
- Valley Cancer Center
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Springfield, Illinois, Forenede Stater, 62702
- Cancer Institute at St. John's Hospital
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Indiana
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Beech Grove, Indiana, Forenede Stater, 46107
- St. Francis Hospital and Health Centers - Beech Grove Campus
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Hammond, Indiana, Forenede Stater, 46320
- Oncology Center at Saint Margaret Mercy Healthcare Center
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Richmond, Indiana, Forenede Stater, 47374
- Reid Hospital & Health Care Services
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Iowa
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Iowa City, Iowa, Forenede Stater, 52242-1002
- Holden Comprehensive Cancer Center at University of Iowa
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Kansas
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Kansas City, Kansas, Forenede Stater, 66112
- Providence Medical Center
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Lawrence, Kansas, Forenede Stater, 66044
- Lawrence Memorial Hospital
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Overland Park, Kansas, Forenede Stater, 66209
- Menorah Medical Center
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Overland Park, Kansas, Forenede Stater, 66210
- Johnson County Radiation Therapy
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Shawnee Mission, Kansas, Forenede Stater, 66204
- Shawnee Mission Medical Center
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Maine
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Lewiston, Maine, Forenede Stater, 04240
- Central Maine Comprehensive Cancer Center at Central Maine Medical Center
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Maryland
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Elkton, Maryland, Forenede Stater, 21921
- Union Hospital Cancer Program at Union Hospital
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- Dana-Farber/Brigham and Women's Cancer Center
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Quincy, Massachusetts, Forenede Stater, 02169
- South Suburban Oncology Center
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South Weymouth, Massachusetts, Forenede Stater, 02190
- South Shore Hospital
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109-0942
- University Of Michigan Comprehensive Cancer Center
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Detroit, Michigan, Forenede Stater, 48202
- Josephine Ford Cancer Center at Henry Ford Hospital
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Kalamazoo, Michigan, Forenede Stater, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, Forenede Stater, 49001
- Borgess Medical Center
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Kalamazoo, Michigan, Forenede Stater, 49007-3731
- West Michigan Cancer Center
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Minnesota
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic Cancer Center
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Missouri
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Cape Girardeau, Missouri, Forenede Stater, 63703
- Cancer Institute of Cape Girardeau, LLC
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Independence, Missouri, Forenede Stater, 64050
- Independence Regional Health Center
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Kansas City, Missouri, Forenede Stater, 64131
- CCOP - Kansas City
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Kansas City, Missouri, Forenede Stater, 64116
- North Kansas City Hospital
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Kansas City, Missouri, Forenede Stater, 64132
- Research Medical Center
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Kansas City, Missouri, Forenede Stater, 64108
- Truman Medical Center - Hospital Hill
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Kansas City, Missouri, Forenede Stater, 64111
- Saint Luke's Cancer Institute at Saint Luke's Hospital
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Kansas City, Missouri, Forenede Stater, 64114
- St. Joseph Medical Center
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Kansas City, Missouri, Forenede Stater, 64116
- Parvin Radiation Oncology
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Kansas City, Missouri, Forenede Stater, 64114
- Kansas City Cancer Center at St. Joseph's Medical Mall
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Kansas City, Missouri, Forenede Stater, 64154
- Radiation Oncology Associates of Kansas City at Northland Radiation Oncology Center
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Saint Joseph, Missouri, Forenede Stater, 64506
- Heartland Regional Medical Center
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Springfield, Missouri, Forenede Stater, 65802
- CCOP - Cancer Research for the Ozarks
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Springfield, Missouri, Forenede Stater, 65804
- St. John's Regional Health Center
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Springfield, Missouri, Forenede Stater, 65807
- Hulston Cancer Center at Cox Medical Center South
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New Jersey
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Camden, New Jersey, Forenede Stater, 08103
- Cancer Institute of New Jersey at Cooper University Hospital - Camden
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Long Branch, New Jersey, Forenede Stater, 07740-6395
- Monmouth Medical Center
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New Brunswick, New Jersey, Forenede Stater, 08903
- Saint Peter's University Hospital
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Vineland, New Jersey, Forenede Stater, 08360
- Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
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Voorhees, New Jersey, Forenede Stater, 08043
- Cancer Institute of New Jersey at Cooper - Voorhees
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87131-5636
- University of New Mexico Cancer Center
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Albuquerque, New Mexico, Forenede Stater, 87102
- Lovelace Medical Center - Downtown
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Albuquerque, New Mexico, Forenede Stater, 87109
- Radiation Oncology Associates, PA
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Santa Fe, New Mexico, Forenede Stater, 87505
- Cancer Institute of New Mexico
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New York
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Buffalo, New York, Forenede Stater, 14263-0001
- Roswell Park Cancer Institute
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New York, New York, Forenede Stater, 10025
- St. Luke's - Roosevelt Hospital Center - St.Luke's Division
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New York, New York, Forenede Stater, 10003-3803
- Beth Israel Medical Center - Petrie Division
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28233-3549
- Presbyterian Cancer Center at Presbyterian Hospital
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Ohio
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Akron, Ohio, Forenede Stater, 44307
- McDowell Cancer Center at Akron General Medical Center
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Akron, Ohio, Forenede Stater, 44309-2090
- Summa Center for Cancer Care at Akron City Hospital
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Cleveland, Ohio, Forenede Stater, 44106-5065
- Case Comprehensive Cancer Center
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Cleveland, Ohio, Forenede Stater, 44112
- Huron Hospital Cancer Care Center
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Cleveland, Ohio, Forenede Stater, 44119
- Euclid Hospital
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Dayton, Ohio, Forenede Stater, 45428
- Veterans Affairs Medical Center - Dayton
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Dayton, Ohio, Forenede Stater, 45405
- Grandview Hospital
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Dayton, Ohio, Forenede Stater, 45406
- Good Samaritan Hospital
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Dayton, Ohio, Forenede Stater, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
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Dayton, Ohio, Forenede Stater, 45415
- Samaritan North Cancer Care Center
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Dayton, Ohio, Forenede Stater, 45429
- CCOP - Dayton
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Findlay, Ohio, Forenede Stater, 45840
- Blanchard Valley Medical Associates
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Franklin, Ohio, Forenede Stater, 45005-1066
- Middletown Regional Hospital
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Kettering, Ohio, Forenede Stater, 45429
- Charles F. Kettering Memorial Hospital
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Mayfield Heights, Ohio, Forenede Stater, 44124
- Hillcrest Cancer Center at Hillcrest Hospital
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Salem, Ohio, Forenede Stater, 44460
- Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
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Troy, Ohio, Forenede Stater, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
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Warrensville Heights, Ohio, Forenede Stater, 44122
- South Pointe Hospital Cancer Care Center
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Wilmington, Ohio, Forenede Stater, 45177
- Clinton Memorial Hospital
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Wooster, Ohio, Forenede Stater, 44691
- Cancer Treatment Center
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Xenia, Ohio, Forenede Stater, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
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Pennsylvania
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Bryn Mawr, Pennsylvania, Forenede Stater, 19010
- Bryn Mawr Hospital
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Drexel Hill, Pennsylvania, Forenede Stater, 19026
- Delaware County Regional Cancer Center at Delaware County Memorial Hospital
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Paoli, Pennsylvania, Forenede Stater, 19301-1792
- Cancer Center of Paoli Memorial Hospital
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Wynnewood, Pennsylvania, Forenede Stater, 19096
- Lankenau Cancer Center at Lankenau Hospital
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Wynnewood, Pennsylvania, Forenede Stater, 19096
- CCOP - Main Line Health
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South Dakota
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Rapid City, South Dakota, Forenede Stater, 57701
- Rapid City Regional Hospital
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Tennessee
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Kingsport, Tennessee, Forenede Stater, 37662
- Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
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Texas
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Houston, Texas, Forenede Stater, 77030-4009
- M. D. Anderson Cancer Center at University of Texas
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Utah
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American Fork, Utah, Forenede Stater, 84003
- American Fork Hospital
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Cedar City, Utah, Forenede Stater, 84720
- Sandra L. Maxwell Cancer Center
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Murray, Utah, Forenede Stater, 84157
- Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
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Ogden, Utah, Forenede Stater, 84403
- Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
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Provo, Utah, Forenede Stater, 84604
- Utah Valley Regional Medical Center - Provo
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Saint George, Utah, Forenede Stater, 84770
- Dixie Regional Medical Center - East Campus
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Salt Lake City, Utah, Forenede Stater, 84112
- Huntsman Cancer Institute at University of Utah
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Salt Lake City, Utah, Forenede Stater, 84103
- LDS Hospital
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Salt Lake City, Utah, Forenede Stater, 84106
- Utah Cancer Specialists at UCS Cancer Center
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Vermont
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Burlington, Vermont, Forenede Stater, 05401
- Fletcher Allen Health Care - University Health Center Campus
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Virginia
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Norton, Virginia, Forenede Stater, 24273
- Southwest Virginia Regional Cancer Center at Wellmonth Health
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Washington
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Seattle, Washington, Forenede Stater, 98101
- CCOP - Virginia Mason Research Center
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Wisconsin
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La Crosse, Wisconsin, Forenede Stater, 54601
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
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Madison, Wisconsin, Forenede Stater, 53792-6164
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
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Mequon, Wisconsin, Forenede Stater, 53097
- Columbia Saint Mary's Hospital - Ozaukee
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Milwaukee, Wisconsin, Forenede Stater, 53211
- Columbia-Saint Mary's Cancer Care Center
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Wausau, Wisconsin, Forenede Stater, 54401
- University of Wisconcin Cancer Center at Aspirus Wausau Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Endometrial Cancer: IMRT
Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT) 28 fractions over 5.5 weeks.
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|
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Andet: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Reproducibility of Radiation Technique (Number of Unacceptable Deviations in Central IMRT Quality Assurance Review)
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Patients With Grade 2+ Bowel Adverse Events
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Anuja Jhingran, MD, M.D. Anderson Cancer Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2006
Primær færdiggørelse (Faktiske)
1. februar 2009
Studieafslutning (Faktiske)
1. december 2016
Datoer for studieregistrering
Først indsendt
30. maj 2006
Først indsendt, der opfyldte QC-kriterier
30. maj 2006
Først opslået (Skøn)
31. maj 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. februar 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. februar 2019
Sidst verificeret
1. februar 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- livmoderhalskræft pladecellekræft
- stadium IIB livmoderhalskræft
- stadium IB livmoderhalskræft
- stadium IIA livmoderhalskræft
- cervikal adenocarcinom
- cervikal adenosquamøst cellecarcinom
- stadium III endometriekarcinom
- stadium II endometriekarcinom
- endometrisk adenokarcinom
- endometrie adenosquamous cell carcinom
- stadium I endometriekarcinom
- endometrial adenocanthom
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RTOG-0418
- CDR0000472905
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .