Status:
UNKNOWN
An International Study on Magnetic Resonance Imaging (MRI)-Guided Brachytherapy in Locally Advanced Cervical Cancer
Lead Sponsor:
Medical University of Vienna
Collaborating Sponsors:
Aarhus University Hospital
UMC Utrecht
Conditions:
Cervical Cancer
Eligibility:
FEMALE
Brief Summary
Background: The standard treatment of locally advanced cervical cancer is radio-chemotherapy including external beam radiotherapy (EBRT), brachytherapy (BT) and concomitant chemotherapy with weekly C...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
1416 Patients enrolled
Trial Details
Trial ID
NCT00920920
Start Date
July 1 2008
End Date
December 1 2021
Last Update
March 25 2021
Active Locations (1)
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1
MUV
Vienna, Austria, 1090