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A study on three dimensional planning using MRI guidance in brachytherapy of locally advanced cancer cervix

Not Applicable
Conditions
Health Condition 1: null- Cancer of the uterine cervix in whom definitive radiotherapy with curative intent is planned.
Registration Number
CTRI/2012/02/002439
Lead Sponsor
Medical University of Vienna
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
600
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

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
local control/morbidityTimepoint: 5 years
Secondary Outcome Measures
NameTimeMethod
regional control <br/ ><br>disease free survival <br/ ><br>overall survival quality of life (QoL)Timepoint: 5 years
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