Pretherapeutic para-aortic lymphadenectomy in advanced stage cervical cancer.

Phase 2

Completed

Conditions: Cervical cancer metastases
metastatic cancer of the cervix
10027476
10013364
10029903

Registration Number: NL-OMON40720

Lead Sponsor: Operatiekamers

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

Age * 18 years
Histologically 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
No evidence of distant metastasis
Fit for surgery
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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the safety and feasibility of para-aortic surgical<br /><br>staging. This will be assessed by registering proportion of included patients<br /><br>amongst all eligible patients. Furthermore by registering duration of surgical<br /><br>procedure, blood loss, complications and adverse events.<br /><br>Nodal yield will be compared to results found in other studies in order to<br /><br>assess completeness of lymphadenectomy. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Data on sensitivity, specificity, negative and positive predictive value of<br /><br>MRI, PET-CT and surgical staging will be gathered to base power calculations<br /><br>for a future independent phase 3 trial.<br /><br><br /><br>The amount and diameter of metastases and proportion of modified initial<br /><br>treatment plans for adjuvant therapy, due to histological findings will be<br /><br>documented.<br /><br>Morbidity and mortality, Quality of life (QLQ-C30 version 3.0, QLQ-CX24) and<br /><br>progression-free and overall survival during the first year after surgery will<br /><br>be compared between treatment arms. Treatment delay due to surgical<br /><br>intervention and histological analyses will be compared. Time to treatment will<br /><br>be measured from the day of randomization until start of chemo radiation.</p><br>