A RANDOMIZED TRIAL COMPARING RADICAL HYSTERECTOMY AND PELVIC NODE DISSECTION VS SIMPLE HYSTERECTOMY AND PELVIC NODE DISSECTION IN PATIENTS WITH LOW RISK EARLY STAGE CERVICAL CANCER

Phase 3

Completed

Conditions: cancer of the cerivx
cervical cancer
10013364

Registration Number: NL-OMON55443

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 110

Inclusion Criteria

squamous of adenocarcinoma of the cervix
< 20 mm AND < 50% stromal infiltration OR < 10 mm depth of invasion
Grade 1, 2 or 3

Exclusion Criteria

High risk histology (clear cell, small cell)
Stage IA1
Evidence of lymph node metastasis or extra-uterine spead on pelvic MRI
Neo-adjuvant chemotherapie
Pregnancy
Desire to preserve fertility

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Endpoint: pelvic relapse-free survival.<br /><br><br /><br>Pelvic Relapse-Free Survival is defined as the date from randomization to the<br /><br>date of first documented reappearance (recurrence) of disease provided that<br /><br>this recurrence is in the pelvis. A pelvic recurrence is defined as a<br /><br>recurrence within the pelvis, below the pelvic brim and inferior to the L4-L5<br /><br>vertebral level. Pelvic recurrences will include disease recurrence in the<br /><br>vaginal vault, parametrium and pelvic lymph nodes (including the common iliac<br /><br>nodes). In the intent-to-treat analysis, patients found to have more advanced<br /><br>stages of cervical cancer on sentinel node mapping, pelvic node dissection or<br /><br>other intraoperative findings consistent with pelvic disease will be considered<br /><br>to have pelvic disease relapse as of the date of the surgical procedure. These<br /><br>patients will be excluded from the per-protocol analysis.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To compare the two treatment arms with respect to:<br /><br>- Extrapelvic relapse-free survival<br /><br>- Relapse-free survival (any site)<br /><br>- Overall survival<br /><br>- Treatment-related toxicity<br /><br>- Patient Reported Outcomes including global quality of life and measures of<br /><br>sexual health<br /><br>- Cost-effectiveness and cost-utility<br /><br><br /><br>To observe rates of the following in this patient population:<br /><br>- Sentinel node detection<br /><br>- Parametrial involvement<br /><br>- Involvement of surgical margins<br /><br>- Pelvic node involvement</p><br>