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Standard Versus Intensity-Modulated Pelvic Radiation Therapy in Treating Patients With Endometrial or Cervical Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01672892
Recruitment Status : Active, not recruiting
First Posted : August 27, 2012
Results First Posted : January 23, 2018
Last Update Posted : April 24, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Brief Summary:

RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This randomized phase III trial is studying two different methods of radiation and their side effects and comparing how well they work in treating endometrial and cervical cancer after surgery.


Condition or disease Intervention/treatment Phase
Cervical Cancer Endometrial Cancer Gastrointestinal Complications Perioperative/Postoperative Complications Radiation Toxicity Urinary Complications Urinary Tract Toxicity Radiation: Standard radiation therapy Radiation: intensity-modulated radiation therapy Phase 3

Detailed Description:

OBJECTIVES:

Primary

  • To determine if pelvic intensity-modulated radiation therapy (IMRT) reduces acute gastrointestinal toxicity in the 5th week (after 23-25 fractions) of pelvic radiation as measured with the expanded prostate cancer index composite (EPIC) instrument.

Secondary

  • To determine if grade 2+ gastrointestinal toxicity (Common Terminology Criteria for Adverse Events version 4.0 [CTCAE v. 4.0]) is reduced with IMRT compared to conventional whole-pelvis radiation therapy (WPRT).
  • To determine if grade 2+ hematologic toxicity (CTCAE v. 4.0) is reduced with IMRT compared to conventional WPRT.
  • To determine if urinary toxicity is reduced with IMRT using the EPIC urinary domain.
  • To validate EPIC bowel and urinary domains in women undergoing either IMRT pelvic radiation treatment or four-field pelvic radiation treatment for endometrial or cervical cancer.
  • To assess the impact of pelvic IMRT on quality of life using the Functional Assessment of Cancer Therapy-General (FACT-G) with cervix subscale.
  • To determine if there is any difference in local-regional control, disease-free survival, and overall survival between patients treated with IMRT as compared to conventional WPRT.
  • To perform a health-utilities analysis to measure the financial impact of pelvic IMRT via the EQ-5D instrument.
  • To identify molecular predictors of radiation toxicity and novel circulating cancer biomarkers.

OUTLINE: This is a multicenter study. Patients are stratified according to type of cancer (endometrial vs cervical), chemotherapy (none vs 5 courses of weekly cisplatin at 40 mg/m²), and radiation dose (45 Gy vs 50.4 Gy). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo standard (3-dimensional) radiation therapy 5 days a week for up to 5-6 weeks.
  • Arm II: Patients undergo intensity-modulated radiation therapy (IMRT) 5 days a week for up to 5-6 weeks.

Some patients receive cisplatin IV over 1 hour on day 1. Treatment continues weekly for 5 weeks, concurrently with radiation therapy, in the absence of unacceptable toxicity or disease progression.

Tissue and blood samples may be collected for biomarker and correlative analysis.

Quality of life may be assessed by questionnaires (including the Expanded Prostate Cancer Index Composite [EPIC], the Functional Assessment of Cancer Therapy-General [FACT-G, Version 4], the EQ-5D, and the Common Toxicity Criteria Adverse Events - Patient-Reported Outcome [PRO-CTCAE]) instruments at baseline and periodically during and after study therapy.

After completion of study therapy, patients are followed every 6 months for the first 2 years and then annually for 5 years.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 289 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase III Study of Standard vs. IMRT Pelvic Radiation for Post-Operative Treatment of Endometrial and Cervical Cancer (TIME-C)
Study Start Date : November 2012
Actual Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Intensity-Modulated Radiation Therapy
intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy
Radiation: Standard radiation therapy
Patients treated once a day, 5 days a week with a daily fraction size of 1.8 Gy. Whole pelvis treated with a four-field technique (AP/PA/R lateral/L lateral) to 45 or 50.4 Gy at 1.8 Gy/fraction. The dose is prescribed to the isocenter which is defined as the intersection of the four beams and can be normalized to an isodose line between 97-100%. The decision to deliver 45 or 50.4 Gy is at the physician's discretion and must be reported at the time of enrollment.
Other Name: RT
Active Comparator: Standard Radiation Therapy
Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
Radiation: intensity-modulated radiation therapy
Patients treated once a day, 5 days a week with a daily fraction size of 1.8 Gy. All targets treated simultaneously. The vaginal planning target volume (PTV) (ITV with 7.0 mm margin) and nodal PTV receives 45 Gy in 25 fractions or 50.4 Gy in 28 fractions. The decision to deliver 45 or 50.4 Gy is at the physician's discretion and must be reported at the time of enrollment.
Other Name: IMRT



Primary Outcome Measures :
  1. Acute Gastrointestinal Toxicity, as Measured by Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel Domain Score at 5 Weeks From the Start of Pelvic Radiation [ Time Frame: Baseline and week 5 of RT ]
    The primary endpoint is change in acute GI toxicity, as measured by the EPIC bowel domain, from baseline to 5 weeks after the first fraction of radiation is delivered. The EPIC has four domains (bowel, urinary, sexual, and hormonal) that have been validated separately, which allows use of only the domains of interest. The EPIC bowel domain consists of 14 items and has a function subscale (7 items) and bother subscale (7 items). For each domain, responses form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, where higher scores correspond to better quality of life. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Change was calculated as follow-up score - baseline score so a negative change score indicates a decline in function.


Secondary Outcome Measures :
  1. Validation of EPIC Bowel and Urinary Domains [ Time Frame: Before study start, Week 3 of RT, Week 5 of RT, 4-6 Weeks after RT, 1 year from start of RT and 3 years from start of RT ]
    Since the EPIC has not been validated in this patient population, a secondary endpoint is to validate the bowel and urinary domains of EPIC in women undergoing either IMRT pelvic radiation treatment or four field pelvic radiation treatments for endometrial or cervical cancer. The bowel and urinary domains of the EPIC can be administered individually since they are separate and distinct modules of the robust and comprehensive EPIC tool.

  2. Percentage of Patients With Acute Grade 2+ GI Toxicity at 5 Weeks From the Start of Treatment [ Time Frame: Baseline to Week 5 of RT ]
    Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (CTCAE) v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.

  3. Urinary Toxicity, as Measured by Change in EPIC Urinary Domain [ Time Frame: Baseline, week 3 and 5 of RT, and 4-6 weeks after RT ]
    The primary endpoint is change in acute GI toxicity, as measured by the EPIC urinary domain, from baseline to 5 weeks after the first fraction of radiation is delivered. The EPIC has four domains (bowel, urinary, sexual, and hormonal) that have been validated separately, which allows use of only the domains of interest. The EPIC urinary domain consists of 12 items and has a function subscale (5 items) and bother subscale (7 items). For each domain, responses form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, where higher scores correspond to better quality of life. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Change was calculated as follow-up score - baseline score so a negative change score indicates a decline in function.

  4. Quality of Life, as Measured by Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) and FACT-Cx (Cervix) Subscale [ Time Frame: Before study start, Week 5 of RT, 4-6 Weeks after RT, 1 year from start of RT and 3 years from start of RT ]
    The FACT-G is a validated, 27-item measure where a higher score represents higher QOL. In addition to a total QOL score, subscale scores for physical, functional, social and emotional well-being are produced. There are 5 responses options, with 0=Not a lot and 4=Very much. All items in a subscale are added together to obtain subscale totals. Scores range from 0-108 for the FACT-G total score, 0-28 for physical, social, functional, and 0-24 for emotional subscale. Certain items must be reversed before it is added by subtracting the response from 4. Subscale totals are summed to form the FACT-G total score. The FACT-Cx is 5-items, with score ranging 0-60, but is not included in total FACT-G. Each subscale requires >= 50% of items completed and overall response rate must be greater than 80%. If items are missing, the subscale scores can be prorated. Change calculated as follow-up score - baseline score so that a negative change score indicates a decline in function.

  5. Health Utilities, as Measured by Change From Baseline in EQ-5D [ Time Frame: Baseline, week 5 of RT, 4-6 weeks after RT ]
    The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). Health states are defined by the combination of the leveled responses to the 5 dimensions, generating 243 health states to which unconsciousness and death are added. The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Both the 5-item index score and the VAS score are transformed into a utility score between 0 (worst health state) and 1 (best health state). Change from baseline is calculated as score at the timepoint of interested - baseline score.

  6. Local-regional Control [ Time Frame: From randomization to 3 years. (Patients are followed until death or study termination, whichever occurs first.) ]
    Local recurrence is defined as a disease in the radiation treatment field. This can include a local vaginal recurrence or nodal disease within the field. Para-aortic recurrence is defined as new lymphadenopathy in the para-aortic distribution. Local-regional control time is defined as time from randomization to the date of local recurrence, last known follow-up (censored), or death (competing risk). Local-regional control rates are estimated using the cumulative incidence method.

  7. Disease-free Survival [ Time Frame: From randomization to 3 years. (Patients are followed until death or study termination, whichever occurs first.) ]
    Disease (progression) is defined as local recurrence, para-aortic recurrence, or distant metastasis. Local recurrence is defined as a disease in the radiation treatment field. This can include a local vaginal recurrence or nodal disease within the field. Para-aortic recurrence is defined as new lymphadenopathy in the para-aortic distribution. Distant metastasis is defined as involvement of another organ or peritoneal disease. Evidence of distant metastases or new lymphadenopathy on surveillance imaging should be biopsied if possible to document disease recurrence. Disease-free survival time is defined as time from randomization to the date of progression, death, or last known follow-up (censored). Disease-free survival rates are estimated using the Kaplan-Meier method.

  8. Overall Survival [ Time Frame: From randomization until 3 years. (Patients are followed until death or study termination, whichever occurs first.) ]
    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.

  9. Identification of Molecular Predictors of Radiation Toxicity and Novel Circulating Cancer Biomarkers [ Time Frame: Tissue samples will be obtained at the time of diagnosis and during the third week of radiation ]
    Biomarker data has not yet been obtained and therefore this outcome measure cannot yet be reported



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Pathologically proven diagnosis of endometrial or cervical cancer.
  2. Patients must have undergone a hysterectomy (total abdominal hysterectomy, vaginal hysterectomy or radical hysterectomy or total laparoscopic hysterectomy) for carcinoma of the cervix or endometrium within 49 days prior to registration. Performance of a bilateral salpingooophorectomy will be at the treating surgeon's discretion.
  3. Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:

    • 3.1 History/physical examination within 45 days prior to registration;
    • 3.2 CT, MRI or positron emission tomography - computed tomography (PET-CT) including the abdomen and pelvis should be performed for initial radiological staging. This may be performed pre- or post-surgery within 90 days prior to registration. Imaging performed post-operatively should show no evidence of residual disease. Any evidence of malignancy identified on pre-operative imaging should have been completely resected surgically prior to protocol treatment.
    • 3.3 Chest CT or chest x-ray must be performed within 90 days prior to registration (unless a PET-CT has been performed)
  4. Zubrod Performance Status 0-2
  5. Age ≥ 18;
  6. Complete blood count (CBC)/differential obtained within 14 days prior to registration on study, with adequate bone marrow function defined as follows:

    • 6.1 Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3;
    • 6.2 Platelets ≥ 100,000 cells/mm3;
    • 6.3 Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.)
  7. For patients receiving chemotherapy:

7.1 Within 14 days prior to registration, serum creatinine ≤ 1.5 mg/dL and calculated creatinine clearance ≥ 50 cc/min. Both tests must be within these limits. The creatinine clearance should be calculated using the Cockcroft-Gault formula: (See Section 7.3.1) 7.2 Aspartate aminotransferase (AST) ≤ 2 x upper limit of normal (ULN) 7.3 Bilirubin ≤ 2 x ULN 7.4 Alkaline phosphatase, Mg, blood urea nitrogen (BUN) and electrolytes must be obtained and recorded 8 Endometrial Cancer: 8.1 Patients with the following histologic features are eligible for pelvic radiation therapy without weekly cisplatin:

  • <50% myometrial invasion, grade 3 adenocarcinoma without uterine serous carcinoma (USC) or clear cell histology
  • ≥50% myometrial invasion grade 1-2 adenocarcinoma without USC or clear cell histology 8.2 Patients with the following histologic features may be treated with pelvic radiation with or without weekly cisplatin. The decision to add weekly cisplatin for these patients is at the treating physician's discretion:
  • ≥50% myometrial invasion, grade 3 including USC and clear cell carcinoma.
  • International Federation of Gynecology and Obstetrics (FIGO) 2009 stage II endometrial cancer of any grade including USC and clear cell carcinoma.
  • FIGO 2009 IIIC1 (pelvic lymph node positive only, para-aortic nodes negative if removed) including USC and clear cell carcinoma. Note: If para-aortic nodes are not removed, CT abdomen or PET CT must demonstrate no evidence of lymphadenopathy. 9. Cervical Cancer: 9.1 Patients with the following pathology findings may be treated with pelvic radiation with or without weekly cisplatin at the treating physician's discretion. The decision to add weekly cisplatin for these patients is at the treating physician's discretion. 9.1.1 Patients with intermediate risk features including two of the following histologic findings after radical hysterectomy:
  • 1/3 or more stromal invasion
  • Lymph-vascular space invasion
  • Large clinical tumor diameter (> 4 cm) 9.1.2 Patients with cervical cancer treated with a simple hysterectomy with negative margins 9.2 Patients with any of the following criteria following radical hysterectomy are eligible for this study and must receive weekly cisplatin:
  • Positive resected pelvic nodes and para-aortic nodes negative if removed. Note: If para-aortic nodes are not removed, CT abdomen or PET CT must demonstrate no evidence of lymphadenopathy.
  • Microscopic parametrial invasion with negative margins. 10. Patient must provide study specific informed consent prior to study entry. 11. Willingness and ability to complete the bowel and urinary domains of the EPIC prior to registration

Exclusion criteria:

  1. Patients with para-aortic nodal disease or who require extended field radiotherapy beyond the pelvis.
  2. Patients with histology consisting of endometrial stromal sarcoma, leiomyosarcoma or malignant mixed mullerian mixed tumor (MMMT or carcinosarcoma)
  3. Patients who exceed the weight/size limits of the treatment table or CT scanner.
  4. Mental status changes or bladder control problems that make the patient unable to comply with bladder-filling instructions.
  5. Patients with evidence of metastatic disease outside of the pelvis.
  6. Patients with positive or close (< 3 mm) resection margins
  7. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years.
  8. Prior radiation therapy to the pelvis
  9. Patients with active inflammatory bowel disease. 10 Severe, active co-morbidity, defined as follows:

    • 10.1 Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
    • 10.2 Transmural myocardial infarction within the last 6 months
    • 10.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
    • 10.4 Other major medical illness which requires hospitalization or precludes study therapy at the time of registration
    • 10.5 Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however,that laboratory test coagulation parameters are not required for entry into this protocol
    • 10.6 Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immunocompromised patients.

11. Patients with prior treatment with platinum-based chemotherapy 12. Women who are breastfeeding


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01672892


  Hide Study Locations
Locations
United States, Arizona
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Arizona Oncology-Deer Valley Center
Phoenix, Arizona, United States, 85027
Arizona Oncology Services Foundation
Scottsdale, Arizona, United States, 85260
United States, California
California Cancer Center - North Fresno
Fresno, California, United States, 93720
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Kaiser Permanente Oakland-Broadway
Oakland, California, United States, 94611
Saint Joseph Hospital - Orange
Orange, California, United States, 92868
Feather River Cancer Center
Paradise, California, United States, 95969
Pomona Valley Hospital Medical Center
Pomona, California, United States, 91767
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California, United States, 95670
Rohnert Park Cancer Center
Rohnert Park, California, United States, 94928
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, United States, 95678
University of California at Davis Cancer Center
Sacramento, California, United States, 95817
South Sacramento Cancer Center
Sacramento, California, United States, 95823
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States, 95051
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, United States, 94080
United States, Colorado
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Swedish Medical Center
Englewood, Colorado, United States, 80113
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, United States, 80120
Longmont United Hospital
Longmont, Colorado, United States, 80501
McKee Medical Center
Loveland, Colorado, United States, 80539
United States, Delaware
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
Beebe Health Campus
Rehoboth Beach, Delaware, United States, 19971
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
University of Florida Health Science Center
Jacksonville, Florida, United States, 32209
Jackson Memorial Hospital-Holtz Children's Hospital
Miami, Florida, United States, 33136
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
United States, Georgia
Grady Health System
Atlanta, Georgia, United States, 30303
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Northside Hospital
Atlanta, Georgia, United States, 30342
Northside Hospital-Forsyth
Cumming, Georgia, United States, 30041
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
Saint Joseph's-Candler Health System
Savannah, Georgia, United States, 31405
United States, Hawaii
Leeward Radiation Oncology Center
'Ewa Beach, Hawaii, United States, 96706
Queen's Medical Center
Honolulu, Hawaii, United States, 96813
University of Hawaii
Honolulu, Hawaii, United States, 96813
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, United States, 96817
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States, 83706
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States, 60612-3785
University of Illinois
Chicago, Illinois, United States, 60612
Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States, 60657
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
United States, Indiana
Saint Vincent Anderson Regional Hospital/Cancer Center
Anderson, Indiana, United States, 46016
Franciscan Saint Margaret Health-Dyer Campus
Dyer, Indiana, United States, 46311
Radiation Oncology Associates PC
Fort Wayne, Indiana, United States, 46804
Franciscan Saint Margaret Health-Hammond Campus
Hammond, Indiana, United States, 46320
United States, Iowa
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States, 50010
Mercy Cancer Center-West Lakes
Clive, Iowa, United States, 50325
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
United States, Louisiana
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States, 70121
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Peninsula Regional Medical Center
Salisbury, Maryland, United States, 21801
Holy Cross Hospital
Silver Spring, Maryland, United States, 20910
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Boston Medical Center
Boston, Massachusetts, United States, 02118
Lowell General Hospital
Lowell, Massachusetts, United States, 01854
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
Milford, Massachusetts, United States, 01757
Dana-Farber/Brigham and Women's Cancer Center at South Shore
South Weymouth, Massachusetts, United States, 02190
D'Amour Center for Cancer Care
Springfield, Massachusetts, United States, 01107
United States, Michigan
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States, 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States, 49503
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
Sanford Clinic North-Bemidgi
Bemidji, Minnesota, United States, 56601
United Hospital
Saint Paul, Minnesota, United States, 55102
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
United States, Missouri
Saint John's Mercy Medical Center
Saint Louis, Missouri, United States, 63141
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
CoxHealth South Hospital
Springfield, Missouri, United States, 65807
United States, Montana
Billings Clinic
Billings, Montana, United States, 59107-7000
United States, Nebraska
The Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New Jersey
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
Mount Holly, New Jersey, United States, 08060
Capital Health Medical Center-Hopewell
Pennington, New Jersey, United States, 08534
Virtua West Jersey Hospital Voorhees
Voorhees, New Jersey, United States, 08043
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87106
United States, New York
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
North Shore-LIJ Health System/Center for Advanced Medicine
New Hyde Park, New York, United States, 11040
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, North Carolina
South Atlantic Radiation Oncology
Supply, North Carolina, United States, 28462
Coastal Carolina Radiation Oncology
Wilmington, North Carolina, United States, 28401
New Hanover Regional Medical Center
Wilmington, North Carolina, United States, 28401
United States, North Dakota
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States, 58501
United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States, 44304
Summa Barberton Hospital
Barberton, Ohio, United States, 44203
Geaugra Hospital
Chardon, Ohio, United States, 44024
Case Western Reserve University
Cleveland, Ohio, United States, 44106
The Mark H Zangmeister Center
Columbus, Ohio, United States, 43219
Summa Health Center at Lake Medina
Medina, Ohio, United States, 44256
Lake University Ireland Cancer Center
Mentor, Ohio, United States, 44060
Southwest General Health Center Ireland Cancer Center
Middleburg Heights, Ohio, United States, 44130
UHHS-Chagrin Highlands Medical Center
Orange Village, Ohio, United States, 44122
Southern Ohio Medical Center
Portsmouth, Ohio, United States, 45662
UHHS-Westlake Medical Center
Westlake, Ohio, United States, 44145
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301
Radiation Therapy Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16803
Reading Hospital
West Reading, Pennsylvania, United States, 19611
Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Self Regional Healthcare
Greenwood, South Carolina, United States, 29646
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
M D Anderson Cancer Center
Houston, Texas, United States, 77030
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
United States, Utah
Logan Regional Hospital
Logan, Utah, United States, 84321
Intermountain Medical Center
Murray, Utah, United States, 84157
Dixie Medical Center Regional Cancer Center
Saint George, Utah, United States, 84770
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
LDS Hospital
Salt Lake City, Utah, United States, 84143
United States, Washington
Saint Francis Hospital
Federal Way, Washington, United States, 98003
Virginia Mason CCOP
Seattle, Washington, United States, 98101
United States, West Virginia
Edwards Comprehensive Cancer Center
Huntington, West Virginia, United States, 25701
United States, Wisconsin
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States, 54311-6519
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Aurora West Allis Medical Center
West Allis, Wisconsin, United States, 53227
Canada, British Columbia
BCCA-Cancer Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
BCCA-Vancouver Island Cancer Centre
Victoria, British Columbia, Canada, V8R 6V5
Canada, Ontario
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
London Regional Cancer Program
London, Ontario, Canada, N6A 4L6
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Hong Kong
Pamela Youde Nethersole Eastern Hospital
Chai Wan, Hong Kong
Singapore
National University Hospital
Singapore, Singapore, 119074
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
NRG Oncology
Investigators
Principal Investigator: Ann Klopp, MD, PhD M.D. Anderson Cancer Center

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT01672892     History of Changes
Other Study ID Numbers: RTOG 1203
CDR0000738944
NCI-2012-02001 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: August 27, 2012    Key Record Dates
Results First Posted: January 23, 2018
Last Update Posted: April 24, 2018
Last Verified: March 2018

Keywords provided by Radiation Therapy Oncology Group:
gastrointestinal complications
perioperative/postoperative complications
radiation toxicity
urinary complications
urinary tract toxicity
endometrial clear cell carcinoma
endometrial papillary serous carcinoma
stage IA endometrial carcinoma
stage IB endometrial carcinoma
stage II endometrial carcinoma
stage IIIA endometrial carcinoma
stage IIIB endometrial carcinoma
stage IIIC endometrial carcinoma
endometrial adenocarcinoma
cervical adenocarcinoma
stage IB cervical cancer
stage IIA cervical cancer
stage IIB cervical cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Endometrial Neoplasms
Postoperative Complications
Radiation Injuries
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Pathologic Processes
Wounds and Injuries