Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, work
in different ways to stop the growth of tumor cells, either by killing the cells or by
stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.
It is not yet known whether chemotherapy and radiation therapy are more effective when given
with or without additional chemotherapy in treating cervical cancer.
PURPOSE: This randomized phase III trial is studying chemotherapy and pelvic radiation
therapy to see how well they work when given with or without additional chemotherapy in
treating patients with high-risk early-stage cervical cancer after radical hysterectomy.
Phase
Phase 3
Funding Agency/Sponsor
National Cooperative Group
Disease
Gynecologic Cancer
Enrollment 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 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