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

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:

• 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

*