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…
ID
Bron
Verkorte titel
Aandoening
Advanced stage uterine cervical cancer, surgical staging, para-aortic lymph node metastases
Gevorderd cervixcarcinoom, chirurgisch stadiëren, para aortale lymfklier metastasen
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
-Proportion of included patients amongst all eligible patients.<br>
-Duration of surgical procedure<br>
-Blood loss<br>
-Complications<br>
-(serious) Adverse events<br>
-Nodal yield
Doel van het onderzoek
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.
Onderzoeksopzet
-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.
Onderzoeksproduct en/of interventie
Para-aortic lymphadenectomy
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
-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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
-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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4782 |
| NTR-old | NTR4922 |
| CCMO | NL49310.091.14 |
| OMON | NL-OMON40720 |