Phase III Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy With or Without Adjuvant Chemotherapy in High-Risk Patients With Early-Stage Cervical Carcinoma Following Radical Hysterectomy

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed squamous, adenosquamous, or adenocarcinoma of the cervix
with any/all of the following high-risk features after surgery:

- Positive pelvic nodes

- Positive parametrium

- Positive para-aortic nodes that have been completely resected and are PET/CT
scan-negative

- PET only required if positive para-aortic nodes during surgery

- Clinical stage IA2, IB, or IIA disease (this corresponds to surgical tumor node
metastasis (TNM) staging of T1-T2, N1, M0)

- Must have undergone radical hysterectomy (open, laparoscopically, or robotic) and
staging within the past 70 days

- Para-aortic and pelvic node sampling required

- If the patient did not have a para-aortic lymph node sampling/dissection,
but had common iliac node dissection that was negative, a PET-CT is
recommended, but not required

- A negative pre- or post-operative PET scan or PET-CT scan of the
para-aortic nodes is required if the patient did not undergo para-aortic or
common iliac nodal sampling/dissection

- No gross residual disease

- No neuroendocrine histology

- No distant metastases

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-1

- Absolute neutrophil count (ANC) ≥ 1,800/mm³

- Platelets ≥ 100,000/mm³

- White blood cell count (WBC) ≥ 4,000/mm³

- Hemoglobin ≥ 10.0 g/dL (transfusion or other intervention allowed)

- Serum creatinine ≤ 1.5 mg/dL

- Bilirubin ≤ 1.5 times upper limit of normal

- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) normal

- Alkaline phosphatase normal

- Known HIV positivity allowed provided cluster of differentiation 4 (CD4) count is ≥
350/mm³ within the past 14 days

- No other invasive malignancy within the past 3 years, except nonmelanomatous skin
cancer or carcinoma in situ of the breast, oral cavity, or cervix

- No severe, active co-morbidity, including any of the following:

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

- Transmural myocardial infarction within the past 6 months

- Acute bacterial or fungal infection requiring IV antibiotics at the time of
study entry

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy at the time of study entry

- Coagulation defects

- No prior allergic reaction to carboplatin, paclitaxel, and/or cisplatin

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior systemic chemotherapy for the current cervical cancer

- Prior chemotherapy for a different cancer is allowed

- No prior radiotherapy to the pelvis that would result in overlap of radiotherapy
fields