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Chemotherapy and Pelvic Radiation Therapy With or Without Additional Chemotherapy in Treating Patients With High-Risk Early-Stage Cervical Cancer After Radical Hysterectomy
Bu çalışma, radikal histerektomi (rahim ameliyatı) sonrası yüksek riskli erken evre serviks (rahim ağzı) kanseri (cervical cancer) olan hastalarda, kemoterapi (carboplatin, cisplatin, paclitaxel) ve pelvik radyoterapinin, ek kemoterapi ile veya olmadan etkisini karşılaştırıyor. Çalışmaya, ameliyat sonrası yüksek risk özellikleri taşıyan serviks kanseri hastaları alınmıştır. Çalışma Faz 3 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
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Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
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