About this trial
The purpose is to compare the conventional 3-dimensional pelvic irradiation with the newer but established radiotherapy IMRT in patients who have had surgery for endometrial cancer.
Post-operative radiotherapy is internationally accepted as standard practice in the management of high-risk endometrial cancer. Whilst it has no proven impact on overall survival it significantly increases local control.
Conventional radiotherapy techniques (3-dimensional) utilise a 3 or 4 field beam arrangement to target the pelvis in order to treat those areas at risk of recurrence: the vagina, the parametrium and the pelvic lymph nodes. However, when using such a technique it is not possible to avoid irradiating sensitive normal tissues such as the bowel and bladder.
Intensity Modulated Radiation Therapy (IMRT) is a newer but established radiotherapy technique in many tumour sites that allows us to much more tightly conform the radiation. It uses computer-generated beams to produce radiotherapy volumes that can avoid irradiation of normal tissues in the pelvis.
There are no randomised studies reported in the literature that compare 3-dimensional pelvic irradiation with IMRT in patients who have had surgery for endometrial cancer. However there are several small studies that report considerable sparing of normal tissues using IMRT and when compared retrospectively with conventionally treated patients demonstrate marked reductions in acute gastrointestinal and genitourinary toxicity.
By delivering post-operative radiotherapy to the pelvis using IMRT (as opposed to the standard 3-dimensional technique) it is anticipated that while local control and survival will be unaffected, acute and late toxicity will be reduced.
Patients undergoing adjuvant pelvic radiotherapy for histologically confirmed endometrial adenocarcinoma / serous carcinoma / papillary serous carcinoma / mixed histology (adenocarcinoma and serous) and following AJCC 2009 grade/stage:
- Grade 2: stage IB (with lymphovascular space invasion or aged over 60)
- Grade 3: stage IA and IB
- Grade 1-3: Stage II and IIIA, IIIB and IIIC1
Where’s this trial being run?St Luke’s Radiation Oncology Network @ Beaumont Hospital, St Luke’s Radiation Oncology Network @ St James’s Hospital, and St Luke’s Radiation Oncology Network @ St Luke’s Hospital
Can I join this study / trial?
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Prospective Randomised Phase II Study evaluating Adjuvant Pelvic Radiotherapy using either IMRT or 3-Dimensional Planning for Endometrial Cancer.
|Principal Investigator:||Dr Charles Gillham (St Luke’s Radiation Oncology Network)|
Cancer Trials Ireland.
Global: Not Applicable
Ireland: February 2010
|Global Recruitment Target:||Not Applicable|
|Ireland Recruitment Target:||154|