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A International Study on MRI-Guided Brachytherapy in Locally Advanced Cervical Cancer

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Cervical Cancer

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Trial Information

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.

Specific Aims

- 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
patient cohort.

- 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.

Inclusion Criteria:

- Cancer of the uterine cervix considered suitable for curative treatment with
definitive radio-(chemo)therapy including MRI guided BT

- Positive biopsy showing squamous-cell carcinoma, adenocarcinoma or adeno-squamous
cell carcinoma of the uterine cervix.

- Staging according to FIGO and TNM guidelines

- MRI of pelvis at diagnosis is performed

- MRI, CT or PET-CT of the retroperitoneal space and abdomen at diagnosis is performed

- MRI with the applicator in place at the time of (first) BT will be performed

- Para-aortic metastatic nodes below L1-L2 are allowed

- Patient informed consent

Exclusion Criteria:

- Other primary malignancies except carcinoma in situ of the cervix and basal cell
carcinoma of the skin

- Metastatic disease beyond para-aortic region (L1-L2)

- Previous pelvic or abdominal radiotherapy

- Previous total or partial hysterectomy

- Combination of preoperative radiotherapy with surgery

- Patients receiving BT only

- Patients receiving EBRT only

- Patients receiving neoadjuvant chemotherapy

- Contra indications to MRI

- Contra indications to BT

- Active infection or severe medical condition endangering treatment delivery

- Pregnant, lactating or childbearing potential without adequate contraception

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

local control/morbidity

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Richard Pötter, Prof., M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Radiotherapy, Medical University of Vienna


Austria: Agency for Health and Food Safety

Study ID:




Start Date:

July 2008

Completion Date:

Related Keywords:

  • Cervical Cancer
  • 3D-4D MRI-based Brachytherapy
  • Cervical Cancer
  • Multicenter Clinical Study
  • Locally advanced cervical cancer
  • Uterine Cervical Neoplasms