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LESs Surgical Radicality for EaRly Stage Cervical Cancer (LESSER)

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ClinicalTrials.gov Identifier: NCT02613286
Recruitment Status : Unknown
Verified March 2019 by Thales Paulo Batista, Hospital de Câncer de Pernambuco.
Recruitment status was:  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

Tracking Information
First Submitted Date  ICMJE November 20, 2015
First Posted Date  ICMJE November 24, 2015
Last Update Posted Date March 7, 2019
Study Start Date  ICMJE May 2015
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
Disease Free Survival [ Time Frame: 3-y DFS ]
Time from surgery to recurrence
Original Primary Outcome Measures  ICMJE
 (submitted: November 23, 2015)
Disease Free Survival [ Time Frame: 3-y DFS ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2015)
  • Treatment-related adverse events (surgical) [ Time Frame: 90 days ]
    Surgical morbidity and mortality
  • Patient reported QoL [ Time Frame: Base-line, 30-90 days, 4-6 months ]
    QoL according to EORTC C30 questionnaire (v3.0).
  • 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
  • Time to starts adjuvant therapy [ Time Frame: 90 days ]
    Time to starts adjuvant therapy (if needed)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE LESs Surgical Radicality for EaRly Stage Cervical Cancer
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Uterine Cervical Neoplasms
Intervention  ICMJE
  • Procedure: Extrafascial Hysterectomy
    Hysterectomy plus Pelvic Lymph-Node Dissection
  • Procedure: Modified radical hysterectomy
    Hysterectomy plus Pelvic Lymph-Node Dissection
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Extrafascial Hysterectomy
  • 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.
    Intervention: Procedure: Modified radical hysterectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 23, 2015)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02613286
Other Study ID Numbers  ICMJE CAAE: 42981715.7.0000.5205
U1111-1176-6929 ( Other Identifier: UTN/WHO )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thales Paulo Batista, Hospital de Câncer de Pernambuco
Study Sponsor  ICMJE Hospital de Câncer de Pernambuco
Collaborators  ICMJE
  • Santa Casa de Misericórdia de Maceió
  • Professor Fernando Figueira Integral Medicine Institute
Investigators  ICMJE Not Provided
PRS Account Hospital de Câncer de Pernambuco
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP