|- candidate number||8527|
|- NTR Number||NTR2552|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-okt-2010|
|- Secondary IDs||10/188 / NL33187.018.10 ; MEC / CCMO|
|- Public Title||Treatment planning techniques in pelvic irradiated patients.|
|- Scientific Title||Treatment planning techniques in pelvic irradiated patients.
Comparison between 3D conformal and IMRT treatment planning techniques in supine and prone position in patients who receive pelvic irradiation.|
|- hypothesis||IMRT treatment planning and irradiation in prone position can reduce the dose to the small bowel.|
|- Healt Condition(s) or Problem(s) studied||Radiotherapy, Rectal cancer, Prone position, Gynaecologic tumor, Small intestine, Toxicity, Organs at risk|
|- Inclusion criteria||1. Patients who are referred to our Radiotherapy department for pelvic irradiation for a gynaecologic or rectal malignancy;|
2. Patients should be able to lie in prone position on a belly-board.
|- Exclusion criteria||1. Unable to lie on a belly-board;|
2. Allergic to iv-contrast;
3. Kidney failure (calculated GFR < 60ml/min);
4. Need for irradiation of the para-aortic lymph nodes.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-okt-2010|
|- planned closingdate||31-dec-2011|
|- Target number of participants||50|
|- Interventions||One extra CT scan before start radiotherapy.|
|- Primary outcome||1. Coverage of the PTV;|
2. Dmean of the small bowel (mean dose in the small bowel);
3. V15 and V45 of the small bowel (volume of the small bowel which receives respectively 15 and 45Gy).
|- Secondary outcome||1. Dmean of the bladder, kidneys, sigmoid and, in case of gynaecologic patients, rectal wall;|
2. V25, V30, V35, V40 and V50 of the small bowel (volume which receives respectively 25, 30, 35, 40 and 50 Gy).
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD. PhD. G.H. Westerveld|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. G.H. Westerveld|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC), Department of Radiotherapy|
|- Brief summary||The aim of this study is to determine if in patients who are referred for pelvic irradiation, IMRT planning (in contrast to conformal 3D planning) gives the lowest dose to the small bowel without increasing the dose in other organs at risk (bladder, kidneys, rectum and sigmoid). In addition, we want to determine in which patients (postoperative endometrial and/or cervical and/or rectal cancer patients), according to dose volume histograms, irradiation in prone position is superior to supine position. For this, we need to make two, instead of one, consecutive CT-scans in prone and supine position respectively, and delineate on both scans the target organs as well as the organs at risk. Finally, we need to make four treatment plans for every patient, namely one IMRT plan in supine position, one IMRT plan in prone position, one 3D conformal plan in supine position and one 3D conformal plan in prone position and compare these plans with each other. |
|- Main changes (audit trail)|
|- RECORD||4-okt-2010 - 15-okt-2010|