Quantifying Radiation Induced Vaginal Stenosis

Inclusion Criteria:

• Patients with histologically confirmed newly diagnosed advanced cervical cancer (squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma): FIGO 2009 clinical stages IB2/IIA with positive para-aortic nodes, or FIGO 2009 clinicalstages IIB/IIIB/IVA with positive pelvic or para-aortic lymph nodes (PALN). Pelvicor PALN nodal status confirmed by PET/CT scan or fine needle biopsy or extraperitoneal biopsy or laparoscopic biopsy. The PALN must be inferior to the T12/L1interspace.

• ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix II).

• Patients must have normal organ and marrow function as defined below:

1. leukocytes ≥2,500/mcL

2. absolute neutrophil count ≥1,500/mcL

3. platelets ≥100,000/mcL

4. hemoglobin ≥8 g/dL (can be transfused with red blood cells pre- study)

5. total bilirubin ≤1.5 × institutional upper limit of normal (ULN)

6. AST(SGOT)/ALT(SGPT) ≤3 × ULN

7. alkaline phosphatase ≤2.5 × ULN

8. creatinine <1.5 mg/dL INR and aPTT ≤1.5 × ULN (This applies only to patientswho do not receive therapeutic anticoagulation; patients receiving therapeuticanticoagulation, such as low-molecular-weight heparin or warfarin, should be ona stable dose.)

• Age is > 18 years.

• Patient does not have a known allergy to cisplatin or compounds of similar biologiccomposition.

• Ability to understand and the willingness to sign a written informed consentdocument.

• Patients positive for human immunodeficiency virus (HIV) are allowed on study, butHIV-positive patients must have:

• A stable regimen of highly active anti-retroviral therapy (HAART)

• No requirement for concurrent antibiotics or antifungal agents for the prevention ofopportunistic infections

• A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standardPCR-based tests.

Exclusion Criteria:

• Patients who have received prior radiation therapy to the pelvis or abdominalcavity, PALN radiation, or previous therapy of any kind for this malignancy orpelvic, PALN, or abdominal radiation for any prior malignancy.

• Patients with PALN nodal metastasis above the T12/L1 interspace.

• Patients who had a radical hysterectomy with positive PALNs are not eligible.

• Patients with prior allogeneic bone marrow transplantation or prior solid organtransplantation.

• Patients previously treated with systemic anticancer therapy (e.g., chemotherapy,targeted therapy, immunotherapy) within 3 years prior to entering the study.

• Patients diagnosed on imaging or biopsy with a synchronous primary malignancy (withthe exception of DCIS of the breast, or early stage basal cell carcinoma of theskin) a. transcription mediated amplification (TMA) or branched DNA testing.

• History or risk of autoimmune disease, including but not limited to systemic lupuserythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosisassociated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's