Prospective Randomised Phase II Trial Evaluating Adjuvant Pelvic Radiotherapy Using Either IMRT or 3-Dimensional Planning for Endometrial Cancer
Primary Objective:
• To compare the incidence of acute grade >2 GU and GI toxicity
Secondary Objectives:
- To establish in the context of a clinical research study the feasibility of
implementing pelvic nodal irradiation using IMRT in gynaecological cancer
- To establish an Image-Guided pathway for gynaecological cancer radiotherapy
incorporating
- Set-up errors and optimal margins for set-up uncertainty
- Investigation of effects of bladder filling and rectal preparation protocols on
the planning target volume
- To estimate the rate of loco-regional control
- To evaluate Quality of Life
- To estimate the rate of disease-free survival
- To estimate the overall survival rate
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Reduction in the incidence of ≥ grade 2 acute genitourinary (GU) and gastrointestinal (GI) toxicity according to NCI CTCAE v.3.0
2015
Yes
Charles Gillham, MD
Principal Investigator
Saint Luke's Hospital
Ireland: Research Ethics Committee
CDR0000680805
NCT01164150
March 2010
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