Trial Information

Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated With Initial Radical Hysterectomy and Pelvic Lymphadenectomy

OBJECTIVES:

Primary

- 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.

Secondary

- 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.

Tertiary

- 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.