Inclusion Criteria

INCLUSION CRITERIA:

- Brachytherapy is indicated after EBRT for all cases of locally advanced disease
(Stages IB2 - IVA)

- Inoperable Stage IA1 and IA2 may be treated with tandem-based brachytherapy alone

- Inoperable Stage IB1 should be treated radically with brachytherapy in conjunction
with EBRT. Concurrent chemotherapy may be considered at the physician's discretion
and based on the presence of high risk features.

- Subjects can be treated with brachytherapy regardless of lymph node status, grade,
and presence of lymphovascular invasion, tumor size, age, or histology.

- Medically fit for general or spinal anesthesia, or conscious sedation, for the
insertion process

- Subjects of childbearing potential must have a negative serum pregnancy test at
Screening inclusion Criteria:

EXCLUSION CRITERIA:

- Medical Contraindications to Brachytherapy (scleroderma, collagen vascular disease,
active lupus )

- Prior pelvic radiotherapy with brachytherapy

- Hemoglobin level at screening < 8

- Life expectancy < 6 months