A Phase I/II, Multi-centre Dose Escalation Study of Simultaneous Boost Intensity-modulated Radiotherapy for Locally Advanced Cervical Cancer
1. Primary objective
- To determine the feasibility of dose escalation with simultaneous boost
intensity-modulated radiotherapy (IMRT) in locally advanced cervical cancer
2. Secondary Objectives
- To assess objective response rates
- To assess local control
- To correlate toxicity with dose-volume histogram data
3. Primary endpoint
- Grade 3 gastrointestinal toxicity at 6 months as defined by CTCAE v3.0 (Common
Terminology for Adverse Events)
4. Secondary endpoints
- Response rate assessed radiologically at 3 months and 12 months
- Local control at 2 years
- Late toxicity at 2 years as defined by CTCAE v3.0
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
severe gastrointestinal toxicity assessed according to Common Terminology for Adverse Event Criteria (CTCAE) v 3.0.
six months of completing radiotherapy
Yes
Dr Melanie Powell
Principal Investigator
Barts Health NHS Trust
United Kingdom: Research Ethics Committee
6883
NCT01793701
July 2010
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