DEPICT: A Phase I/II, Multi-Center Dose Escalation Study of Simultaneous Boost Intensity-Modulated Radiotherapy for Locally Advanced Cervical Cancer
- To determine the feasibility of dose-escalation of chemoradiotherapy comprising
cisplatin in combination with simultaneous-boost intensity-modulated radiotherapy
(IMRT) in patients with locally advanced cervical cancer.
- To assess the objective response rates in patients treated with this regimen.
- To assess the local control of the disease in patients treated with this regimen.
- To correlate toxicity with dose-volume histogram data in these patients.
OUTLINE: This is a multicenter, phase I, dose-escalation study followed by a phase II study.
Patients receive cisplatin IV over 1 hour weekly for up to 5 weeks. Patients also undergo
intensity-modulated radiotherapy 5 days a week for approximately 6 weeks.
Patients complete a quality-of-life questionnaire at baseline, during, and after completion
of study therapy.
After completion of study treatment, patients are followed up at 4 and 12 weeks, every 3
months for 2 years, and then periodically for 5 years.
Masking: Open Label, Primary Purpose: Treatment
Grade 3 gastrointestinal toxicity at 6 months as defined by CTCAE v 3.0
St. Bartholomew's Hospital