| Eligibility: |
Histologic proof of squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix, including FIGO (International Federation of Gynecologists and Obstetricians) stage IIB to IIIB or patients with FIGO stage IB to IIA who have biopsy-proven pelvic node metastases and/or tumor size > 5 cm. All patients must have confirmation of diagnosis by cervical biopsy. Zubrod Performance Status 0-2. Laboratory values must be as follows (Within 21 Days of registration):
| White blood cell count: | > 3,000/mm3 |
| Absolute granulocyte count: | > 1,500/mm3 |
| Platelets: | > 100,000/mm3 |
| Total bilirubin: | < 1.5 mg/dl |
| Serum creatinine: | < 1.5 mg/dl |
| AST and ALT: | < 2.5 x institutional upper normal limit |
| Serum calcium: | < 1.3 x institutional upper normal limit |
| INR: | < 1.5 |
| Serum Pregnancy: | Negative |
| Hemoglobin | > 10 - Transfusion may be used to meet this criterion |
Urine protein screening must be performed within 21 days of study entry. If urine analysis for urine protein creatinine (UPC) ratio > 0.5, then a 24-hour urine protein must be performed and must be < 1000 mg. UPC is calculated using one of the following formulas:
- [urine protein]/[urine creatinine] - if both protein and creatinine are reported in mg/dL
- [(urine protein) x0.088]/[urine creatinine] - if urine creatinine is reported in mmol/L
Chest X-Ray, Chest CT, or PET-CT within 8 weeks prior to study entry. Evaluation of para-aortic lymph nodes is required to at least the level of the renal vessels by contrast-enhanced CT, MRI or PET-CT within 8 weeks prior to study entry. All patients with suspicious para-aortic lymph nodes on CT, MRI or PET-CT must have biopsy by fine needle aspirate or laparoscopy or laparotomy. FDG-PET scanning can be used to supplement cross sectional imaging for determination of nodal involvement or distant metastases. PET imaging is encouraged, but not required. CT, MRI or PET-CT of the abdomen/pelvis that must include evaluation of the abdomen to at least the level of the renal vessels, with contrast-enhancement, within 8 weeks prior to study entry. MRI of the pelvis is strongly preferred in order to allow tumor measurement in three dimensions. Signed study-specific informed consent prior to study entry.
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| Treatment: |
Pelvic RT: 45 Gy given in 25 once-daily fractions (1.8 Gy/fraction) Monday-Friday over 5 weeks, then LDR x 2 or HDR x 5, then parametrial boost (if indicated)
Bevacizumab (Avastin®): IV Q2 weeks (Days 1, 15 and 29) during chemoradiation, given before cisplatin, on the same day as cisplatin
Cisplatin: Weekly infusion x 6 weeks
Proton pump inhibitor (PPI) medications must be administered to all patients.
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