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

Inclusion criteria:

1. Pathologically proven diagnosis of endometrial or cervical cancer.
2. Patients must have undergone a hysterectomy (total abdominal hysterectomy, vaginalhysterectomy or radical hysterectomy or total laparoscopic hysterectomy) for carcinomaof the cervix or endometrium within 49 days prior to registration. Performance of abilateral salpingooophorectomy will be at the treating surgeon's discretion.
3. Appropriate stage for protocol entry, including no distant metastases, based upon thefollowing 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 radiologicalstaging. This may be performed pre- or post-surgery within 90 days prior toregistration. Imaging performed post-operatively should show no evidence ofresidual disease. Any evidence of malignancy identified on pre-operative imagingshould have been completely resected surgically prior to protocol treatment.
• 3.3 Chest CT or chest x-ray must be performed within 90 days prior toregistration (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 registrationon 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 toachieve 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 calculatedcreatinine clearance ≥ 50 cc/min. Both tests must be within these limits. The creatinineclearance should be calculated using the Cockcroft-Gault formula: (See Section 7.3.1) 7.2Aspartate 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 obtainedand recorded 8 Endometrial Cancer: 8.1 Patients with the following histologic features areeligible 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 pelvicradiation with or without weekly cisplatin. The decision to add weekly cisplatin forthese 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 endometrialcancer of any grade including USC and clear cell carcinoma.
• FIGO 2009 IIIC1 (pelvic lymph node positive only, para-aortic nodes negative ifremoved) including USC and clear cell carcinoma. Note: If para-aortic nodes are notremoved, CT abdomen or PET CT must demonstrate no evidence of lymphadenopathy. 9.Cervical Cancer: 9.1 Patients with the following pathology findings may be treatedwith pelvic radiation with or without weekly cisplatin at the treating physician'sdiscretion. The decision to add weekly cisplatin for these patients is at the treatingphysician's discretion. 9.1.1 Patients with intermediate risk features including twoof 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 treatedwith a simple hysterectomy with negative margins 9.2 Patients with any of thefollowing criteria following radical hysterectomy are eligible for this study and mustreceive weekly cisplatin:
• Positive resected pelvic nodes and para-aortic nodes negative if removed. Note: Ifpara-aortic nodes are not removed, CT abdomen or PET CT must demonstrate no evidenceof lymphadenopathy.
• Microscopic parametrial invasion with negative margins. 10. Patient must provide studyspecific informed consent prior to study entry. 11. Willingness and ability tocomplete 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 radiotherapybeyond the pelvis.
2. Patients with histology consisting of endometrial stromal sarcoma, leiomyosarcoma ormalignant 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 tocomply 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 freefor 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 hospitalizationwithin 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 thetime of registration
• 10.4 Other major medical illness which requires hospitalization or precludesstudy therapy at the time of registration
• 10.5 Hepatic insufficiency resulting in clinical jaundice and/or coagulationdefects; note, however,that laboratory test coagulation parameters are notrequired for entry into this protocol
• 10.6 Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers forDisease Control and Prevention (CDC) definition; note, however, that HIV testingis not required for entry into this protocol. The need to exclude patients withAIDS from this protocol is necessary because the treatments involved in thisprotocol may be significantly immunosuppressive. Protocol-specific requirementsmay also exclude immunocompromised patients.

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