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LESs Surgical Radicality for EaRly Stage Cervical Cancer (LESSER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02613286
Recruitment Status : Completed
First Posted : November 24, 2015
Last Update Posted : June 15, 2022
Sponsor:
Collaborators:
Santa Casa de Misericórdia de Maceió
Professor Fernando Figueira Integral Medicine Institute
Information provided by (Responsible Party):
Thales Paulo Batista, Hospital de Câncer de Pernambuco

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Uterine Cervical Neoplasms Procedure: Extrafascial Hysterectomy Procedure: Modified radical hysterectomy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Proof of concept design (phase II non-inferiority trial)
Masking: Single (Participant)
Masking Description: Due to the surgical nature of the study, only participants were masked to treatment allocation
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 2015
Actual Primary Completion Date : April 2018
Actual Study Completion Date : May 10, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Disease Free Survival (3-y DFS) [ Time Frame: 3 years ]
    Time from surgery to recurrence


Secondary Outcome Measures :
  1. Treatment-related adverse events (surgical) [ Time Frame: 90 days ]
    Surgical morbidity and mortality

  2. Patient reported QoL [ Time Frame: Base-line and 6 months. ]
    QoL according to EORTC C30 questionnaire (v3.0)

  3. 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

  4. Overall survival (3-y OS) [ Time Frame: 3 years ]
    Time from surgery to death of any cause


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Thales Paulo Batista, Consultant Physician and Researcher (Surgical Oncology), Hospital de Câncer de Pernambuco
ClinicalTrials.gov Identifier: NCT02613286    
Other Study ID Numbers: CAAE: 42981715.7.0000.5205
U1111-1176-6929 ( Other Identifier: UTN/WHO )
First Posted: November 24, 2015    Key Record Dates
Last Update Posted: June 15, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
 Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases