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
- Conditions
- Endometrial CancerCervical Cancer
- Interventions
- Radiation: intensity-modulated radiation therapy
- Registration Number
- NCT00331760
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 106
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Endometrial Cancer: IMRT intensity-modulated radiation therapy Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT) 28 fractions over 5.5 weeks. Cervical Cancer: IMRT + Chemotherapy (cisplatin) intensity-modulated radiation therapy 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. Cervical Cancer: IMRT + Chemotherapy (cisplatin) 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.
- Primary Outcome Measures
Name Time Method Reproducibility of Radiation Technique (Number of Unacceptable Deviations in Central IMRT Quality Assurance Review) 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%.
- Secondary Outcome Measures
Name Time Method Rate of Distant Metastases at Five Years 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.
Percentage of Patients With Grade 2+ Bowel Adverse Events 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.
Percentage of Patients With Any Grade 3+ Treatment-related Adverse Events 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.
Rate of Local-regional Failure at Five Years 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.
Rate of Overall Survival at Five Years From randomization to five years Overall survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
Percentage of Patients With Any Late Grade 3+ Treatment-related Adverse Events 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.
Percentage of Cervical Carcinoma Patients That Were Chemotherapy Compliant 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.
Rate of Disease-free Survival at Five Years From registration five years Disease-free survival time is defined as time from registration to date of failure (any tumor recurrence, development of distant metastases or death from any cause) and is estimated by the Kaplan-Meier method. Patients last known to be alive without failure are censored at the date of last contact.
Trial Locations
- Locations (152)
Union Hospital Cancer Program at Union Hospital
🇺🇸Elkton, Maryland, United States
Johnson County Radiation Therapy
🇺🇸Overland Park, Kansas, United States
Monmouth Medical Center
🇺🇸Long Branch, New Jersey, United States
South Shore Hospital
🇺🇸South Weymouth, Massachusetts, United States
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
Mason District Hospital
🇺🇸Havana, Illinois, United States
Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States
Huron Hospital Cancer Care Center
🇺🇸Cleveland, Ohio, United States
Euclid Hospital
🇺🇸Cleveland, Ohio, United States
CCOP - Virginia Mason Research Center
🇺🇸Seattle, Washington, United States
M. D. Anderson Cancer Center at University of Texas
🇺🇸Houston, Texas, United States
Shawnee Mission Medical Center
🇺🇸Shawnee Mission, Kansas, United States
Menorah Medical Center
🇺🇸Overland Park, Kansas, United States
Providence Medical Center
🇺🇸Kansas City, Kansas, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Highland General Hospital
🇺🇸Oakland, California, United States
Bay Area Breast Surgeons, Incorporated
🇺🇸Oakland, California, United States
Valley Medical Oncology
🇺🇸Fremont, California, United States
Auburn Radiation Oncology
🇺🇸Auburn, California, United States
East Bay Radiation Oncology Center
🇺🇸Castro Valley, California, United States
Eden Medical Center
🇺🇸Castro Valley, California, United States
Valley Medical Oncology Consultants - Castro Valley
🇺🇸Castro Valley, California, United States
Valley Medical Oncology Consultants - Pleasanton
🇺🇸Pleasanton, California, United States
Graham Hospital
🇺🇸Canton, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
Doctors Medical Center - San Pablo Campus
🇺🇸San Pablo, California, United States
Hopedale Medical Complex
🇺🇸Hopedale, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
🇺🇸Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
🇺🇸Ottawa, Illinois, United States
Galesburg Cottage Hospital
🇺🇸Galesburg, Illinois, United States
Cancer Treatment Center at Pekin Hospital
🇺🇸Pekin, Illinois, United States
Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
🇺🇸Olympia Fields, Illinois, United States
InterCommunity Cancer Center of Western Illinois
🇺🇸Galesburg, Illinois, United States
Proctor Hospital
🇺🇸Peoria, Illinois, United States
Illinois Valley Community Hospital
🇺🇸Peru, Illinois, United States
McDonough District Hospital
🇺🇸Macomb, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Perry Memorial Hospital
🇺🇸Princeton, Illinois, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
BroMenn Regional Medical Center
🇺🇸Normal, Illinois, United States
Community Cancer Center
🇺🇸Normal, Illinois, United States
Community Hospital of Ottawa
🇺🇸Ottawa, Illinois, United States
St. Margaret's Hospital
🇺🇸Spring Valley, Illinois, United States
Cancer Institute at St. John's Hospital
🇺🇸Springfield, Illinois, United States
Valley Cancer Center
🇺🇸Spring Valley, Illinois, United States
Reid Hospital & Health Care Services
🇺🇸Richmond, Indiana, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
🇺🇸Beech Grove, Indiana, United States
Cancer Institute of Cape Girardeau, LLC
🇺🇸Cape Girardeau, Missouri, United States
Truman Medical Center - Hospital Hill
🇺🇸Kansas City, Missouri, United States
Kansas City Cancer Center at St. Joseph's Medical Mall
🇺🇸Kansas City, Missouri, United States
Independence Regional Health Center
🇺🇸Independence, Missouri, United States
North Kansas City Hospital
🇺🇸Kansas City, Missouri, United States
Parvin Radiation Oncology
🇺🇸Kansas City, Missouri, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Research Medical Center
🇺🇸Kansas City, Missouri, United States
Radiation Oncology Associates of Kansas City at Northland Radiation Oncology Center
🇺🇸Kansas City, Missouri, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
Lovelace Medical Center - Downtown
🇺🇸Albuquerque, New Mexico, United States
St. John's Regional Health Center
🇺🇸Springfield, Missouri, United States
Heartland Regional Medical Center
🇺🇸Saint Joseph, Missouri, United States
Radiation Oncology Associates, PA
🇺🇸Albuquerque, New Mexico, United States
University of New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States
Cancer Institute of New Mexico
🇺🇸Santa Fe, New Mexico, United States
Beth Israel Medical Center - Petrie Division
🇺🇸New York, New York, United States
St. Luke's - Roosevelt Hospital Center - St.Luke's Division
🇺🇸New York, New York, United States
Presbyterian Cancer Center at Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
McDowell Cancer Center at Akron General Medical Center
🇺🇸Akron, Ohio, United States
Summa Center for Cancer Care at Akron City Hospital
🇺🇸Akron, Ohio, United States
Grandview Hospital
🇺🇸Dayton, Ohio, United States
Good Samaritan Hospital
🇺🇸Dayton, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
Samaritan North Cancer Care Center
🇺🇸Dayton, Ohio, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Blanchard Valley Medical Associates
🇺🇸Findlay, Ohio, United States
Middletown Regional Hospital
🇺🇸Franklin, Ohio, United States
Charles F. Kettering Memorial Hospital
🇺🇸Kettering, Ohio, United States
Hillcrest Cancer Center at Hillcrest Hospital
🇺🇸Mayfield Heights, Ohio, United States
South Pointe Hospital Cancer Care Center
🇺🇸Warrensville Heights, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
🇺🇸Troy, Ohio, United States
Cancer Treatment Center
🇺🇸Wooster, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
🇺🇸Xenia, Ohio, United States
Bryn Mawr Hospital
🇺🇸Bryn Mawr, Pennsylvania, United States
CCOP - Main Line Health
🇺🇸Wynnewood, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital
🇺🇸Wynnewood, Pennsylvania, United States
Southwest Virginia Regional Cancer Center at Wellmonth Health
🇺🇸Norton, Virginia, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
🇺🇸La Crosse, Wisconsin, United States
Columbia Saint Mary's Hospital - Ozaukee
🇺🇸Mequon, Wisconsin, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
Dana-Farber/Brigham and Women's Cancer Center
🇺🇸Boston, Massachusetts, United States
Dixie Regional Medical Center - East Campus
🇺🇸Saint George, Utah, United States
Central Maine Comprehensive Cancer Center at Central Maine Medical Center
🇺🇸Lewiston, Maine, United States
Fletcher Allen Health Care - University Health Center Campus
🇺🇸Burlington, Vermont, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
University of Wisconcin Cancer Center at Aspirus Wausau Hospital
🇺🇸Wausau, Wisconsin, United States
Cancer Institute of New Jersey at Cooper University Hospital - Camden
🇺🇸Camden, New Jersey, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
🇺🇸Murray, Utah, United States
Tunnell Cancer Center at Beebe Medical Center
🇺🇸Lewes, Delaware, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Saint Peter's University Hospital
🇺🇸New Brunswick, New Jersey, United States
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
🇺🇸Vineland, New Jersey, United States
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
🇺🇸Ogden, Utah, United States
Cancer Institute of New Jersey at Cooper - Voorhees
🇺🇸Voorhees, New Jersey, United States
American Fork Hospital
🇺🇸American Fork, Utah, United States
Veterans Affairs Medical Center - San Diego
🇺🇸San Diego, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Josephine Ford Cancer Center at Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
LDS Hospital
🇺🇸Salt Lake City, Utah, United States
Utah Cancer Specialists at UCS Cancer Center
🇺🇸Salt Lake City, Utah, United States
Huntsman Cancer Institute at University of Utah
🇺🇸Salt Lake City, Utah, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Columbia-Saint Mary's Cancer Care Center
🇺🇸Milwaukee, Wisconsin, United States
Radiological Associates of Sacramento Medical Group, Incorporated
🇺🇸Sacramento, California, United States
Mercy General Hospital
🇺🇸Sacramento, California, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Radiation Oncology Centers - Cameron Park
🇺🇸Cameron Park, California, United States
Mercy Cancer Center at Mercy San Juan Medical Center
🇺🇸Carmichael, California, United States
Valley Care Medical Center
🇺🇸Pleasanton, California, United States
Radiation Oncology Center - Roseville
🇺🇸Roseville, California, United States
Solano Radiation Oncology Center
🇺🇸Vacaville, California, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
St. Joseph Medical Center
🇺🇸Kansas City, Missouri, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
🇺🇸Chicago, Illinois, United States
Bay Medical
🇺🇸Panama City, Florida, United States
Memorial Hospital
🇺🇸Carthage, Illinois, United States
Galesburg Clinic, PC
🇺🇸Galesburg, Illinois, United States
Alexian Brothers Radiation Oncology
🇺🇸Elk Grove Village, Illinois, United States
Eureka Community Hospital
🇺🇸Eureka, Illinois, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
Lawrence Memorial Hospital
🇺🇸Lawrence, Kansas, United States
South Suburban Oncology Center
🇺🇸Quincy, Massachusetts, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Borgess Medical Center
🇺🇸Kalamazoo, Michigan, United States
Saint Luke's Cancer Institute at Saint Luke's Hospital
🇺🇸Kansas City, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
🇺🇸Springfield, Missouri, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
🇺🇸Salem, Ohio, United States
Clinton Memorial Hospital
🇺🇸Wilmington, Ohio, United States
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
🇺🇸Kingsport, Tennessee, United States
Utah Valley Regional Medical Center - Provo
🇺🇸Provo, Utah, United States
Sandra L. Maxwell Cancer Center
🇺🇸Cedar City, Utah, United States
McGill Cancer Centre at McGill University
🇨🇦Montreal, Quebec, Canada
Alta Bates Summit Medical Center - Summit Campus
🇺🇸Oakland, California, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
Larry G Strieff MD Medical Corporation
🇺🇸Oakland, California, United States
Tom K Lee, Incorporated
🇺🇸Oakland, California, United States
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
🇺🇸Drexel Hill, Pennsylvania, United States
Cancer Center of Paoli Memorial Hospital
🇺🇸Paoli, Pennsylvania, United States
Oncology Center at Saint Margaret Mercy Healthcare Center
🇺🇸Hammond, Indiana, United States