Standard Versus Intensity-Modulated Pelvic Radiation Therapy in Treating Patients With Endometrial or Cervical Cancer
Cervical Cancer, Endometrial Cancer, Gastrointestinal Complications
About this trial
This is an interventional treatment trial for Cervical Cancer focused on measuring 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
Eligibility Criteria
Inclusion criteria:
- Pathologically proven diagnosis of endometrial or cervical cancer.
- 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.
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)
- Zubrod Performance Status 0-2
- Age ≥ 18;
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.)
- 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:
- Patients with para-aortic nodal disease or who require extended field radiotherapy beyond the pelvis.
- Patients with histology consisting of endometrial stromal sarcoma, leiomyosarcoma or malignant mixed mullerian mixed tumor (MMMT or carcinosarcoma)
- Patients who exceed the weight/size limits of the treatment table or CT scanner.
- Mental status changes or bladder control problems that make the patient unable to comply with bladder-filling instructions.
- Patients with evidence of metastatic disease outside of the pelvis.
- Patients with positive or close (< 3 mm) resection margins
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years.
- Prior radiation therapy to the pelvis
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
Sites / Locations
- Banner MD Anderson Cancer Center
- Arizona Oncology-Deer Valley Center
- Arizona Oncology Services Foundation
- California Cancer Center - North Fresno
- UC San Diego Moores Cancer Center
- Kaiser Permanente Oakland-Broadway
- Saint Joseph Hospital - Orange
- Feather River Cancer Center
- Pomona Valley Hospital Medical Center
- Kaiser Permanente-Rancho Cordova Cancer Center
- Rohnert Park Cancer Center
- The Permanente Medical Group-Roseville Radiation Oncology
- University of California at Davis Cancer Center
- South Sacramento Cancer Center
- Kaiser Permanente Medical Center - Santa Clara
- Kaiser Permanente Cancer Treatment Center
- University of Colorado Cancer Center - Anschutz Cancer Pavilion
- Penrose-Saint Francis Healthcare
- Porter Adventist Hospital
- Swedish Medical Center
- Rocky Mountain Cancer Centers-Littleton
- Longmont United Hospital
- McKee Medical Center
- Christiana Care Health System-Christiana Hospital
- Beebe Health Campus
- Washington Hospital Center
- University of Florida
- University of Florida Health Science Center
- Jackson Memorial Hospital-Holtz Children's Hospital
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- Grady Health System
- Piedmont Hospital
- Emory University/Winship Cancer Institute
- Northside Hospital
- Northside Hospital-Forsyth
- Northeast Georgia Medical Center
- Saint Joseph's-Candler Health System
- Leeward Radiation Oncology Center
- Queen's Medical Center
- University of Hawaii
- The Cancer Center of Hawaii-Liliha
- Saint Alphonsus Cancer Care Center-Boise
- Northwestern University
- John H Stroger Jr Hospital of Cook County
- University of Illinois
- Advocate Illinois Masonic Medical Center
- Ingalls Memorial Hospital
- Saint Vincent Anderson Regional Hospital/Cancer Center
- Franciscan Saint Margaret Health-Dyer Campus
- Radiation Oncology Associates PC
- Franciscan Saint Margaret Health-Hammond Campus
- McFarland Clinic PC-William R Bliss Cancer Center
- Mercy Cancer Center-West Lakes
- Iowa Methodist Medical Center
- Mercy Medical Center - Des Moines
- Mary Bird Perkins Cancer Center
- Ochsner Medical Center Jefferson
- Greater Baltimore Medical Center
- Sinai Hospital of Baltimore
- Peninsula Regional Medical Center
- Holy Cross Hospital
- Brigham and Women's Hospital
- Dana-Farber Cancer Institute
- Boston Medical Center
- Lowell General Hospital
- Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
- Dana-Farber/Brigham and Women's Cancer Center at South Shore
- D'Amour Center for Cancer Care
- Saint Joseph Mercy Hospital
- Wayne State University/Karmanos Cancer Institute
- Saint John Hospital and Medical Center
- Mercy Health Saint Mary's
- Spectrum Health at Butterworth Campus
- Saint John Macomb-Oakland Hospital
- Sanford Clinic North-Bemidgi
- United Hospital
- Ridgeview Medical Center
- Saint John's Mercy Medical Center
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Billings Clinic
- The Nebraska Medical Center
- Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
- Capital Health Medical Center-Hopewell
- Virtua West Jersey Hospital Voorhees
- University of New Mexico
- Long Island Jewish Medical Center
- North Shore-LIJ Health System/Center for Advanced Medicine
- Stony Brook University Medical Center
- South Atlantic Radiation Oncology
- Coastal Carolina Radiation Oncology
- New Hanover Regional Medical Center
- Sanford Bismarck Medical Center
- Summa Akron City Hospital/Cooper Cancer Center
- Summa Barberton Hospital
- Geaugra Hospital
- Case Western Reserve University
- The Mark H Zangmeister Center
- Summa Health Center at Lake Medina
- Lake University Ireland Cancer Center
- Southwest General Health Center Ireland Cancer Center
- UHHS-Chagrin Highlands Medical Center
- Southern Ohio Medical Center
- UHHS-Westlake Medical Center
- University of Oklahoma Health Sciences Center
- Abington Memorial Hospital
- Paoli Memorial Hospital
- Radiation Therapy Oncology Group
- Mount Nittany Medical Center
- Reading Hospital
- Lankenau Hospital
- Medical University of South Carolina
- Self Regional Healthcare
- Rapid City Regional Hospital
- Sanford USD Medical Center - Sioux Falls
- University of Texas Southwestern Medical Center
- M D Anderson Cancer Center
- University of Texas Health Science Center at San Antonio
- Logan Regional Hospital
- Intermountain Medical Center
- Dixie Medical Center Regional Cancer Center
- Huntsman Cancer Institute/University of Utah
- LDS Hospital
- Saint Francis Hospital
- Virginia Mason CCOP
- Edwards Comprehensive Cancer Center
- Aurora BayCare Medical Center
- Aurora Saint Luke's Medical Center
- Aurora West Allis Medical Center
- BCCA-Cancer Centre for the Southern Interior
- BCCA-Vancouver Island Cancer Centre
- Juravinski Cancer Centre at Hamilton Health Sciences
- London Regional Cancer Program
- Allan Blair Cancer Centre
- Saskatoon Cancer Centre
- Pamela Youde Nethersole Eastern Hospital
- National University Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Intensity-Modulated Radiation Therapy
Standard Radiation Therapy
intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy
Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy