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Pretherapeutic surgical staging of para-aortic lymph nodes in advanced stage uterine cervical cancer.


- candidate number21029
- NTR NumberNTR4922
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-nov-2014
- Secondary IDsNL49310.091.14 ID medical ethical committee
- Public TitlePretherapeutic surgical staging of para-aortic lymph nodes in advanced stage uterine cervical cancer.
- Scientific TitlePretherapeutic para-aortic lymphadenectomy in advanced stage cervical cancer.
- ACRONYMPALDISC
- hypothesisImaging 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) studiedCervix 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).
-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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2014
- planned closingdate1-dec-2018
- Target number of participants30
- InterventionsPara-aortic lymphadenectomy
- Primary outcome-Proportion of included patients amongst all eligible patients.
-Duration of surgical procedure
-Blood loss
-Complications
-(serious) Adverse events
-Nodal yield
- Secondary outcomeData 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
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. R.L.M. Bekkers
- CONTACT for SCIENTIFIC QUERIESDr. R.L.M. Bekkers
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Radboud University Medical Centre Nijmegen
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD24-nov-2014 - 1-feb-2015


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