No registrations found.
ID
Source
Brief title
Health condition
Advanced stage uterine cervical cancer, surgical staging, para-aortic lymph node metastases
Gevorderd cervixcarcinoom, chirurgisch stadiëren, para aortale lymfklier metastasen
Sponsors and support
Intervention
Outcome measures
Primary outcome
-Proportion of included patients amongst all eligible patients.
-Duration of surgical procedure
-Blood loss
-Complications
-(serious) Adverse events
-Nodal yield
Secondary outcome
Data on sensitivity, specificity, negative and positive predictive value for a future independent phase 3 trial.
Number and diameter of metastases and proportion of modified initial treatment plans due to histological findings.
Morbidity and mortality, Quality of life and progression-free and overall survival during the first year after surgery.
Treatment delay due to surgical intervention and histological analyses.
Study objective
Imaging modalities such as computed tomography (CT), positron emission tomography (PET), and magnetic resonance imaging (MRI) are limited by low sensitivity and specificity to detect para-aortic lymph node metastases in advanced stage cervical cancer when compared with surgical staging. Para aortic lymph node status is the most important prognostic factor, together with tumour stage.
This study will assess safety and feasibility of surgical staging in locally advanced cervical cancer in the Netherlands.
Study design
-Diagnostic biopsy, within 6 weeks of surgery
- EUA within 6 weeks of surgery
- FIGO staging within 6 weeks of surgery
- chest x-ray and/or CT scan, and/or pelvic MRI, and Pet-CT within 6 weeks of surgery
- Quality of Life (QLQ-C30 version 3.0, QLQ-CX24), at inclusion, 2 and 6 weeks after surgical staging, and 3, 6, and 12 months after start treatment.
Intervention
Para-aortic lymphadenectomy
Department of Obstetrics & Gynaecology (791)<br>
P.O. Box 9101
R.L.M. Bekkers
Nijmegen 6500 HB
The Netherlands
+31 (0)24 3614725
R.Bekkers@obgyn.umcn.nl
Department of Obstetrics & Gynaecology (791)<br>
P.O. Box 9101
R.L.M. Bekkers
Nijmegen 6500 HB
The Netherlands
+31 (0)24 3614725
R.Bekkers@obgyn.umcn.nl
Inclusion criteria
-Age > 18 years
-Histological confirmed squamous cell, adenosquamous or adenocarcinoma of the cervix
-Stage IB2 , IIA with tumor > 4cm,IIB, IIIA, IIIB, IVA, staging performed as examination under anesthesia (EUA).
-WHO-performance 0-2
-WBC > 3.0x 109/L, platelets > 100 x 109/L, creatinine clearance > 60ml/min
-Chest CT or X-ray, abdominal MRI, or CT scan, and PET-CT with no evidence of distant metastasis
-Written informed consent
Exclusion criteria
-Previous malignancy (except for non-melanoma skin cancer)
-Prior retroperitoneal surgery
-Previous pelvic or abdominal radiotherapy
-Upper abdominal intraperitoneal disease or evidence of ovarian metastasis
-Evidence of distant metastasis on imaging or physical examination
-Bulky para-aortic lymph nodes > 2cm
-Pregnancy
-Otherwise unfit for surgery
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4782 |
| NTR-old | NTR4922 |
| CCMO | NL49310.091.14 |
| OMON | NL-OMON40720 |