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This study compares chemotherapy (carboplatin, cisplatin, paclitaxel) plus pelvic radiation therapy, with or without additional chemotherapy, in patients with high-risk early-stage cervical cancer after radical hysterectomy. It enrolled cervical cancer patients with high-risk features after surgery. The study was conducted in Phase 3 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
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Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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 positron emission tomography (PET)/computed tomography (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