Phase II/III Clinical Trial of Intensity Modulated Radiation Therapy With Concurrent Cisplatin for Stage I-IVA Cervical Carcinoma

Inclusion Criteria:

- Biopsy-proven, invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous
carcinoma of the cervix

- Biopsy result positive for carcinoma within 60 days prior to registration

- FIGO clinical stage I-IVA disease, based on standard diagnostic workup,
including:History/physical examination and/or Examination under anesthesia (if
indicated)

- If the patient is status post hysterectomy, one or more of the following conditions
must be present: positive lymph nodes, positive margins, parametrial invasion, or
non-radical surgery (i.e., simple hysterectomy).

- If the patient is inoperable, one or more of the following conditions must be
present: clinical stage IB2-IVA, positive lymph nodes on nodal sampling or frozen
section, and/or parametrial invasion

- Within 42 days prior to registration, the patient must have any of the following, if
clinically indicated: examination under anesthesia, cystoscopy, sigmoidoscopy, rigid
proctoscopy, or colonoscopy.

- X-ray (PA and lateral), CT scan, or PET/CT scan of the chest within 42 days prior to
registration;

- CT scan, MRI, or PET/CT of the pelvis within 42 days prior to registration;

- Karnofsky Performance Status 60-100

- Absolute neutrophil count (ANC) ≥ 1500 cells/mm3; Platelets ≥ 100,000 cells/mm3;
Hemoglobin ≥ 10.0 g/dl (Note: The use of transfusion or other intervention to achieve
Hgb ≥ 10.0 g/dl is acceptable); Creatinine clearance ≥ 50 mg/dl; Bilirubin < 1.5
mg/dl; WBC ≥ 3,000/μl; ALT/AST < 3 x ULN; INR ≤ 1.5

- Negative serum pregnancy test for women of child-bearing potential

Exclusion Criteria:

- Prior invasive malignancy (except non-melanomatous skin cancer), unless disease free
for a minimum of 3 years;

- Prior systemic chemotherapy within the past three years

- Prior radiotherapy to the pelvis or abdomen that would result in overlap of radiation
therapy fields;

- Para-aortic, inguinal, or gross (unresected) pelvic nodal metastasis. Gross pelvic
nodal metastasis is defined as either: Radiographic evidence of nodal metastasis on
CT or MRI (node having short axis diameter > 1 cm)OR Radiographic evidence of nodal
metastasis on diagnostic FDG-PET or PET/CT scan (abnormally increased FDG uptake as
determined and documented by the radiologist)OR Biopsy-proven metastasis (e.g. needle
biopsy) in undissected node

- Distant metastasis

- Unstable angina and/or congestive heart failure requiring hospitalization within the
past 6 months

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

- Uncontrolled diabetes, defined as diabetes mellitus, which in the opinion of any of
the patient's physicians requires an immediate change in management;

- Uncompensated heart disease or uncontrolled high blood pressure

- Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition