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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 : Active, not recruiting
First Posted : November 24, 2015
Last Update Posted : March 7, 2019
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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Proof of concept design (phase II non-inferiority trial)
Masking: None (Open Label)
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
Study Start Date : May 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Disease Free Survival [ Time Frame: 3-y DFS ]
    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, 30-90 days, 4-6 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. Time to starts adjuvant therapy [ Time Frame: 90 days ]
    Time to starts adjuvant therapy (if needed)



Information from the National Library of Medicine

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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.
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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: March 7, 2019
Last Verified: March 2019
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