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
Cervical Cancer, Endometrial Cancer
About this trial
This is an interventional treatment trial for Cervical Cancer focused on measuring stage I endometrial carcinoma, stage II endometrial carcinoma, stage III endometrial carcinoma, endometrial adenoacanthoma, endometrial adenocarcinoma, endometrial adenosquamous cell carcinoma, stage IB cervical cancer, stage IIA cervical cancer, stage IIB cervical cancer, cervical adenocarcinoma, cervical adenosquamous cell carcinoma, cervical squamous cell carcinoma
Eligibility Criteria
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
Sites / Locations
- Auburn Radiation Oncology
- Radiation Oncology Centers - Cameron Park
- Mercy Cancer Center at Mercy San Juan Medical Center
- East Bay Radiation Oncology Center
- Eden Medical Center
- Valley Medical Oncology Consultants - Castro Valley
- City of Hope Comprehensive Cancer Center
- Valley Medical Oncology
- Rebecca and John Moores UCSD Cancer Center
- Highland General Hospital
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Breast Surgeons, Incorporated
- CCOP - Bay Area Tumor Institute
- Larry G Strieff MD Medical Corporation
- Tom K Lee, Incorporated
- Valley Care Medical Center
- Valley Medical Oncology Consultants - Pleasanton
- Radiation Oncology Center - Roseville
- Radiological Associates of Sacramento Medical Group, Incorporated
- Mercy General Hospital
- Veterans Affairs Medical Center - San Diego
- UCSF Helen Diller Family Comprehensive Cancer Center
- Doctors Medical Center - San Pablo Campus
- Solano Radiation Oncology Center
- Tunnell Cancer Center at Beebe Medical Center
- CCOP - Christiana Care Health Services
- Mayo Clinic - Jacksonville
- Bay Medical
- St. Joseph Medical Center
- Graham Hospital
- Memorial Hospital
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- Alexian Brothers Radiation Oncology
- Eureka Community Hospital
- Galesburg Clinic, PC
- Galesburg Cottage Hospital
- InterCommunity Cancer Center of Western Illinois
- Mason District Hospital
- Hopedale Medical Complex
- McDonough District Hospital
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- BroMenn Regional Medical Center
- Community Cancer Center
- Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
- Community Hospital of Ottawa
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
- Cancer Treatment Center at Pekin Hospital
- Proctor Hospital
- OSF St. Francis Medical Center
- CCOP - Illinois Oncology Research Association
- Oncology Hematology Associates of Central Illinois, PC - Peoria
- Methodist Medical Center of Illinois
- Illinois Valley Community Hospital
- Perry Memorial Hospital
- St. Margaret's Hospital
- Valley Cancer Center
- Cancer Institute at St. John's Hospital
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Oncology Center at Saint Margaret Mercy Healthcare Center
- Reid Hospital & Health Care Services
- Holden Comprehensive Cancer Center at University of Iowa
- Providence Medical Center
- Lawrence Memorial Hospital
- Menorah Medical Center
- Johnson County Radiation Therapy
- Shawnee Mission Medical Center
- Central Maine Comprehensive Cancer Center at Central Maine Medical Center
- Union Hospital Cancer Program at Union Hospital
- Dana-Farber/Brigham and Women's Cancer Center
- South Suburban Oncology Center
- South Shore Hospital
- University of Michigan Comprehensive Cancer Center
- Josephine Ford Cancer Center at Henry Ford Hospital
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Mayo Clinic Cancer Center
- Cancer Institute of Cape Girardeau, LLC
- Independence Regional Health Center
- Truman Medical Center - Hospital Hill
- Saint Luke's Cancer Institute at Saint Luke's Hospital
- Kansas City Cancer Center at St. Joseph's Medical Mall
- St. Joseph Medical Center
- North Kansas City Hospital
- Parvin Radiation Oncology
- CCOP - Kansas City
- Research Medical Center
- Radiation Oncology Associates of Kansas City at Northland Radiation Oncology Center
- Heartland Regional Medical Center
- CCOP - Cancer Research for the Ozarks
- St. John's Regional Health Center
- Hulston Cancer Center at Cox Medical Center South
- Cancer Institute of New Jersey at Cooper University Hospital - Camden
- Monmouth Medical Center
- Saint Peter's University Hospital
- Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
- Cancer Institute of New Jersey at Cooper - Voorhees
- Lovelace Medical Center - Downtown
- Radiation Oncology Associates, PA
- University of New Mexico Cancer Center
- Cancer Institute of New Mexico
- Roswell Park Cancer Institute
- Beth Israel Medical Center - Petrie Division
- St. Luke's - Roosevelt Hospital Center - St.Luke's Division
- Presbyterian Cancer Center at Presbyterian Hospital
- McDowell Cancer Center at Akron General Medical Center
- Summa Center for Cancer Care at Akron City Hospital
- Case Comprehensive Cancer Center
- Huron Hospital Cancer Care Center
- Euclid Hospital
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Blanchard Valley Medical Associates
- Middletown Regional Hospital
- Charles F. Kettering Memorial Hospital
- Hillcrest Cancer Center at Hillcrest Hospital
- Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
- UVMC Cancer Care Center at Upper Valley Medical Center
- South Pointe Hospital Cancer Care Center
- Clinton Memorial Hospital
- Cancer Treatment Center
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Bryn Mawr Hospital
- Delaware County Regional Cancer Center at Delaware County Memorial Hospital
- Cancer Center of Paoli Memorial Hospital
- CCOP - Main Line Health
- Lankenau Cancer Center at Lankenau Hospital
- Rapid City Regional Hospital
- Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
- M. D. Anderson Cancer Center at University of Texas
- American Fork Hospital
- Sandra L. Maxwell Cancer Center
- Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
- Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
- Utah Valley Regional Medical Center - Provo
- Dixie Regional Medical Center - East Campus
- LDS Hospital
- Utah Cancer Specialists at UCS Cancer Center
- Huntsman Cancer Institute at University of Utah
- Fletcher Allen Health Care - University Health Center Campus
- Southwest Virginia Regional Cancer Center at Wellmonth Health
- CCOP - Virginia Mason Research Center
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
- Columbia Saint Mary's Hospital - Ozaukee
- Columbia-Saint Mary's Cancer Care Center
- University of Wisconcin Cancer Center at Aspirus Wausau Hospital
- Princess Margaret Hospital
- McGill Cancer Centre at McGill University
Arms of the Study
Arm 1
Arm 2
Other
Other
Endometrial Cancer: IMRT
Cervical Cancer: IMRT + Chemotherapy (cisplatin)
Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT) 28 fractions over 5.5 weeks.
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.