A International Study on MRI-Guided Brachytherapy in Locally Advanced Cervical Cancer
A prospective observational multicenter study will be performed in patients with locally
advanced cervical cancer considered to be potentially curable by definitive radio-(chemo)
therapy. The patients will be divided and analyzed in three strata according to risk of
1. Small tumours
2. Large tumours favourable response
3. Large tumours with unfavourable response to the initial radio-(chemo) therapy.
A clinical local failure has to be validated by MRI and topographically correlated to the
MRI based BT targets (HR CTV and IR-CTV) and the dose volume parameters of the treatment
plan. It has to be classified as "inside", "at the edge", "outside".
Major events with regard to morbidity have to be reported using 3D imaging information
integrating e.g. clinical examination, endoscopy and MRI. The location of organ damage (i.e.
fistula) has to be identified in 3D and a correlation to the dose volume parameters for the
affected region should be investigated.
- To assess prospectively outcome for disease (local control, survival), for morbidity
and for QoL life applying appropriate clinical, imaging and QoL protocols.
- To test that there are three groups representing different risks of recurrence: small
tumours; large tumours with favourable response; large tumours with unfavourable
response to initial radio-(chemo)therapy.
- To correlate local control (survival) and dose volume parameters for GTV and CTV for
the overall cohort and for the 3 different risk groups and to establish hazard ratios
and dose effect curves for the primary tumour.
- To correlate outcome data and dose volume parameters for the different OAR (rectum,
sigmoid, bladder) and to establish hazard ratios and dose effect curves for OAR.
- To correlate QoL outcome to morbidity outcome.
- To quantify the change in DVH parameters obtained by image guided dose optimization of
BT in the individual patient.
- To compare volumetric data on GTV and CTV at diagnosis and during treatment and relate
them to dose volume parameters within the 3 different risk groups of the overall
- To evaluate the indicators for quality assessment throughout the whole study period in
order to define systematic and random variations for the different indicators (e.g.
contouring, applicator reconstruction, dose volume assessment).
- To validate from clinical outcome data the radiobiological equivalence calculations
used for assessing dose and volume parameters in gynaecological radiotherapy.
- To test if the GYN GEC ESTRO recommendations for BT in cervical cancer are feasible in
a multi-centre setting.
Observational Model: Cohort, Time Perspective: Prospective
Richard Pötter, Prof., M.D.
Department of Radiotherapy, Medical University of Vienna
Austria: Agency for Health and Food Safety