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RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation therapy together with chemotherapy is more effective than radiation therapy alone in treating patients with cervical cancer.
PURPOSE: This randomized phase III trial is studying giving radiation therapy together with chemotherapy to see how well it works compared to radiation therapy alone in treating patients with stage I or stage II cervical cancer who previously underwent surgery.
- To determine if post-operative adjuvant chemoradiotherapy (CRT) can significantly improve recurrence-free survival (RFS) when compared to radiation therapy (RT) alone in patients with intermediate-risk factors stage I-IIA cervical cancer after treatment with radical hysterectomy.
- To compare the overall survival (OS) of patients treated with these regimens.
- To assess differences in incidence and severity of regimen-attributed adverse events in these patients.
- To provide assessment of patient risk vs benefit (positive study only).
- To determine whether post-operative adjuvant CRT improves the health-related quality-of-life compared to RT alone.
- To compare toxicity profiles with particular focus on treatment-related genitourinary, gastrointestinal, neurological, pain, and sexual adverse events in these patients.
- To bank archival tumor tissue for research studies, including studies that evaluate the association between biomarkers, RFS, OS, and clinical-surgical-pathologic characteristics in patients treated with these regimens.
- To bank DNA from whole blood for research studies, including studies that evaluate associations between single nucleotide polymorphisms (SNPs), and measures of clinical outcome, including RFS, OS, and adverse events in patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients are stratified according to capillary-lymphovascular space involvement (positive vs negative), stromal invasion (deep vs middle vs superficial), radiotherapy modality (external-beam radiation therapy [EBRT] vs intensity-modulated radiation therapy [IMRT]), and cooperative group (KGOG vs GOG). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo pelvic EBRT or IMRT 5 days a week for 5.5 weeks.
- Arm II: Patients receive cisplatin IV over 1-2 hours on day 1 and undergo radiotherapy as in arm I. Treatment with cisplatin repeats every 7 days for up to 6 weeks in the absence of disease progression or unacceptable toxicity.
Patients complete questionnaires on smoking history, Functional Assessment of Cancer Therapy (FACT-G, Version 4), FACT-Neurotoxicity subscale, and the Brief Pain Inventory (BPI) at baseline and periodically during study.
Tumor tissue and blood samples may be collected and banked for future biomarker and other analysis.
After completion of study therapy, patients are followed up every 3 months for 2 years, and then every 6 months for 3 years.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
cisplatin, external beam radiation therapy, intensity-modulated radiation therapy
Providence Saint Joseph Medical Center - Burbank
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:14:39-0400
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