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

RTOG-0724

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.

2009-09-01

2023-12-14

2028-08-31

Active (not recruiting)

Early phase I

238

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 238, 'type': 'ACTUAL'}}

2024-02-05