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LESs Surgical Radicality for EaRly Stage Cervical Cancer

NCT02613286 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-06-15

No results posted yet for this study

Summary

This study is an open-label, multicenter, randomized, phase II non-inferiority trial (proof of concept study). Its purpose is to evaluate the safety and efficacy of extrafascial hysterectomy plus pelvic-lymph node dissection compared with the standard modified radical hysterectomy in patients with stage IA2-IB1 cervical cancer ≤ 2cm.

Conditions

  • Uterine Cervical Neoplasms

Interventions

PROCEDURE

Extrafascial Hysterectomy

Hysterectomy plus Pelvic Lymph-Node Dissection

PROCEDURE

Modified radical hysterectomy

Hysterectomy plus Pelvic Lymph-Node Dissection

Sponsors & Collaborators

  • Santa Casa de Misericórdia de Maceió

    collaborator OTHER

  • Professor Fernando Figueira Integral Medicine Institute

    collaborator OTHER

  • Hospital de Câncer de Pernambuco

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2018-04-30
Completion
2022-05-10

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02613286 on ClinicalTrials.gov