|- candidate number||21029|
|- NTR Number||NTR4922|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-nov-2014|
|- Secondary IDs||NL49310.091.14 ID medical ethical committee|
|- Public Title||Pretherapeutic surgical staging of para-aortic lymph nodes in advanced stage uterine cervical cancer.|
|- Scientific Title||Pretherapeutic para-aortic lymphadenectomy in advanced stage cervical cancer.|
|- hypothesis||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.
|- Healt Condition(s) or Problem(s) studied||Cervix cancer, Lymph node metastase, Surgical staging|
|- 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).
-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
-Otherwise unfit for surgery
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-dec-2014|
|- planned closingdate||1-dec-2018|
|- Target number of participants||30|
|- Interventions||Para-aortic lymphadenectomy|
|- Primary outcome||-Proportion of included patients amongst all eligible patients.|
-Duration of surgical procedure
-(serious) Adverse events
|- 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.
|- Timepoints||-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.
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Dr. R.L.M. Bekkers|
|- CONTACT for SCIENTIFIC QUERIES||Dr. R.L.M. Bekkers|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|Radboud University Medical Center Nijmegen|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||24-nov-2014 - 1-feb-2015|