A Phase II Study of Intensity Modulated Radiation Therapy (IMRT) to the Pelvis ± Chemotherapy for Post-Operative Patients With Either Endometrial or Cervical Carcinoma
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.
Interventional
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Reproducibility of Radiation Technique (Number of Unacceptable Deviations in Central IMRT Quality Assurance Review)
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.
No
Anuja Jhingran, MD
Study Chair
M.D. Anderson Cancer Center
United States: Federal Government
CDR0000472905
NCT00331760
March 2006
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse, Wisconsin 54601 |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792-6164 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
CCOP - Dayton | Kettering, Ohio 45429 |
LDS Hospital | Salt Lake City, Utah 84143 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
Monmouth Medical Center | Long Branch, New Jersey 07740-6395 |
Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
Veterans Affairs Medical Center - San Diego | San Diego, California 92161 |
Fletcher Allen Health Care - University Health Center Campus | Burlington, Vermont 05401 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Saint Peter's University Hospital | New Brunswick, New Jersey 08901-1780 |
American Fork Hospital | American Fork, Utah 84003 |
Utah Cancer Specialists at UCS Cancer Center | Salt Lake City, Utah 84106 |
UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Beth Israel Medical Center - Petrie Division | New York, New York 10003-3803 |
St. Luke's - Roosevelt Hospital Center - St.Luke's Division | New York, New York 10027 |
M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Hillcrest Cancer Center at Hillcrest Hospital | Mayfield Heights, Ohio 44124 |
Eden Medical Center | Castro Valley, California 94546 |
Alta Bates Summit Medical Center - Summit Campus | Oakland, California 94609 |
Valley Care Medical Center | Pleasanton, California 94588 |
St. Joseph Medical Center | Bloomington, Illinois 61701 |
Graham Hospital | Canton, Illinois 61520 |
Memorial Hospital | Carthage, Illinois 62321 |
Eureka Community Hospital | Eureka, Illinois 61530 |
Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
InterCommunity Cancer Center of Western Illinois | Galesburg, Illinois 61401 |
Mason District Hospital | Havana, Illinois 62644 |
Hopedale Medical Complex | Hopedale, Illinois 61747 |
McDonough District Hospital | Macomb, Illinois 61455 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Community Cancer Center | Normal, Illinois 61761 |
Community Hospital of Ottawa | Ottawa, Illinois 61350 |
Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa, Illinois 61350 |
Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria, Illinois 61615 |
OSF St. Francis Medical Center | Peoria, Illinois 61637 |
Proctor Hospital | Peoria, Illinois 61614 |
Illinois Valley Community Hospital | Peru, Illinois 61354 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
St. Margaret's Hospital | Spring Valley, Illinois 61362 |
Valley Cancer Center | Spring Valley, Illinois 61362 |
St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove, Indiana 46107 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
Grandview Hospital | Dayton, Ohio 45405 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
Good Samaritan Hospital | Dayton, Ohio 45406 |
Blanchard Valley Medical Associates | Findlay, Ohio 45840 |
Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
Middletown Regional Hospital | Middletown, Ohio 45044 |
UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
Delaware County Regional Cancer Center at Delaware County Memorial Hospital | Drexel Hill, Pennsylvania 19026 |
Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center | Kingsport, Tennessee 37662 |
Dixie Regional Medical Center - East Campus | Saint George, Utah 84770 |
Highland General Hospital | Oakland, California 94602 |
South Suburban Oncology Center | Quincy, Massachusetts 02169 |
Huron Hospital Cancer Care Center | Cleveland, Ohio 44112 |
Euclid Hospital | Cleveland, Ohio 44119 |
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford | Salem, Ohio 44460 |
South Pointe Hospital Cancer Care Center | Warrensville Heights, Ohio 44122 |
Cancer Treatment Center | Wooster, Ohio 44691 |
Tunnell Cancer Center at Beebe Medical Center | Lewes, Delaware 19958 |
Reid Hospital & Health Care Services | Richmond, Indiana 47374 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Menorah Medical Center | Overland Park, Kansas 66209 |
Shawnee Mission Medical Center | Shawnee Mission, Kansas 66204 |
Union Hospital Cancer Program at Union Hospital | Elkton MD, Maryland 21921 |
Truman Medical Center - Hospital Hill | Kansas City, Missouri 64108 |
St. Joseph Medical Center | Kansas City, Missouri 64114 |
North Kansas City Hospital | Kansas City, Missouri 64116 |
Saint Luke's Cancer Institute at Saint Luke's Hospital | Kansas City, Missouri 64111 |
Research Medical Center | Kansas City, Missouri 64132 |
Heartland Regional Medical Center | Saint Joseph, Missouri 64506 |
Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
Clinton Memorial Hospital | Wilmington, Ohio 45177 |
Sandra L. Maxwell Cancer Center | Cedar City, Utah 84720 |
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray, Utah 84157 |
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center | Ogden, Utah 84403 |
Southwest Virginia Regional Cancer Center at Wellmonth Health | Norton, Virginia 24273 |
Radiological Associates of Sacramento Medical Group, Incorporated | Sacramento, California 95815 |
Dana-Farber/Brigham and Women's Cancer Center | Boston, Massachusetts 02115 |
Cancer Institute at St. John's Hospital | Springfield, Illinois 62701 |
University of Wisconcin Cancer Center at Aspirus Wausau Hospital | Wausau, Wisconsin 54401 |
Solano Radiation Oncology Center | Vacaville, California 95687 |
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare | Vineland, New Jersey 08360 |
Doctors Medical Center - San Pablo Campus | San Pablo, California 94806 |
Galesburg Clinic, PC | Galesburg, Illinois 61401 |
Providence Medical Center | Kansas City, Kansas 66112 |
Johnson County Radiation Therapy | Overland Park, Kansas 66210 |
Independence Regional Health Center | Independence, Missouri 64050 |
Kansas City Cancer Center at St. Joseph's Medical Mall | Kansas City, Missouri 64114 |
Parvin Radiation Oncology | Kansas City, Missouri 64116 |
Radiation Oncology Associates of Kansas City at Northland Radiation Oncology Center | Kansas City, Missouri 64154 |
Mercy General Hospital | Sacramento, California 95819 |
East Bay Radiation Oncology Center | Castro Valley, California 94546 |
Larry G Strieff MD Medical Corporation | Oakland, California 94609 |
Tom K Lee, Incorporated | Oakland, California 94609 |
Bay Area Breast Surgeons, Incorporated | Oakland, California 94609 |
Valley Medical Oncology Consultants - Pleasanton | Pleasanton, California 94588 |
Alexian Brothers Radiation Oncology | Elk Grove Village, Illinois 60007 |
Cancer Center of Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
CCOP - Main Line Health | Wynnewood, Pennsylvania 19096 |
Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields | Olympia Fields, Illinois 60461 |
Bay Medical | Panama City, Florida 32401 |
Oncology Center at Saint Margaret Mercy Healthcare Center | Hammond, Indiana 46320 |
Cancer Institute of Cape Girardeau, LLC | Cape Girardeau, Missouri 63703 |
South Shore Hospital | South Weymouth, Massachusetts 02190 |
Cancer Institute of New Jersey at Cooper University Hospital - Camden | Camden, New Jersey 08103 |
Lovelace Medical Center - Downtown | Albuquerque, New Mexico 87102 |
Valley Medical Oncology Consultants - Castro Valley | Castro Valley, California 94546 |
Valley Medical Oncology | Fremont, California 94538 |
Columbia Saint Mary's Hospital - Ozaukee | Mequon, Wisconsin 53097 |
Columbia-Saint Mary's Cancer Care Center | Milwaukee, Wisconsin 53211 |
Central Maine Comprehensive Cancer Center at Central Maine Medical Center | Lewiston, Maine 04240 |
Radiation Oncology Associates, PA | Albuquerque, New Mexico 87109 |
Auburn Radiation Oncology | Auburn, California 95603 |
Radiation Oncology Centers - Cameron Park | Cameron Park, California 95682 |
Radiation Oncology Center - Roseville | Roseville, California 95661 |
Mercy Cancer Center at Mercy San Juan Medical Center | Carmichael, California 95608 |
Cancer Institute of New Mexico | Santa Fe, New Mexico 87505 |