LESs Surgical Radicality for EaRly Stage Cervical Cancer (LESSER)

June 13, 2022 updated by: Thales Paulo Batista, Hospital de Câncer de Pernambuco

A Proof of Concept Non-inferiority Trial Evaluating the Safety and Efficacy of Extrafascial Hysterectomy Plus Pelvic Lymph-node Dissection in Patients With Stage IA2-IB1 Cervical Cancer ≤ 2cm

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this study is to evaluate the safety and efficacy of extrafascial hysterectomy compared with modified radical hysterectomy, both plus level 1 pelvic lymph-node dissection, in patients with early stage IA2-IB1 cervical cancer ≤ 2cm. The experimental procedure will be considered to be promising for treatment of stage IA2-IB1 cervical cancer ≤ 2cm if the Bayesian posterior probability of "the difference of the 3-y DFS rate is less than the non-inferiority margin of 5%" is at least 50%. Thus, using this proof of concept design, the planned sample size is 40, with 20 cases per arm, which provides 72% chance of satisfying the above criteria, under the hypothesis that the lowest 3-y DFS rate in each arm is 90%. As required, adjuvant therapy will include cisplatin-based chemo-radiation or pelvic radiation alone (EBRT +/- intracavitary brachytherapy) indicated according to the #GOG92 and #GOG109 criteria.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Patients with histologically confirmed adenocarcinoma, squamous, or adenosquamous cancer of the cervix by LEEP, cone or cervical biopsy;
  2. Aged between 18 and 70 years;
  3. performance status 0-2 (ECOG, Eastern Cooperative Oncology Group) and / or greater than 70 points by the Karnofsky scale;
  4. FIGO early stage IA2-IB1 ≤ 2cm;
  5. Appropriated cardio-respiratory, hepato-renal and hematological reserves; and
  6. Signing of the Consent Form.

Exclusion Criteria:

  1. Limiting systemic comorbidities including neuro-psychiatric disorders or obesity;
  2. Apparent or confirmed uncontrolled infections;
  3. Other malignancies in activity;
  4. Previous radiation or chemotherapy treatment or major pelvic surgery;
  5. History of drug allergies, and pregnancy or breast feeding; and
  6. Evidence of more extensive disease at the time of surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Extrafascial Hysterectomy
Type A hysterectomy with 1 - 2cm of vaginal cuff plus level 1 pelvic lymph-node dissection according to Querleu and Morrow classification.
Procedure: Extrafascial Hysterectomy
Hysterectomy plus Pelvic Lymph-Node Dissection
ACTIVE_COMPARATOR: Modified radical hysterectomy
Type B2 hysterectomy with 1 - 2cm of vaginal cuff plus level 1 pelvic lymph-node dissection according to Querleu and Morrow classification.
Procedure: Modified radical hysterectomy
Hysterectomy plus Pelvic Lymph-Node Dissection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Disease Free Survival (3-y DFS)
Time Frame: 3 years
Time from surgery to recurrence
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Treatment-related adverse events (surgical)
Time Frame: 90 days
Surgical morbidity and mortality
90 days
Patient reported QoL
Time Frame: Base-line and 6 months.
QoL according to EORTC C30 questionnaire (v3.0)
Base-line and 6 months.
Rates of using adjuvant therapy
Time Frame: 90 days
Cisplatin-based chemo-radiation or pelvic radiation alone (EBRT +/- intracavitary brachytherapy) indicated according to the #GOG92 and #GOG109 criteria
90 days
Overall survival (3-y OS)
Time Frame: 3 years
Time from surgery to death of any cause
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital de Câncer de Pernambuco

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Professor Fernando Figueira Integral Medicine Institute
Santa Casa de Misericórdia de Maceió

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 10, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 24, 2015

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CAAE: 42981715.7.0000.5205
  • U1111-1176-6929 (OTHER: UTN/WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings