LESs Surgical Radicality for EaRly Stage Cervical Cancer | NCT02613286

Studies
LESs Surgical Radicality for EaRly Stage Cervical Cancer

NCT02613286

Sponsor

Hospital de Câncer de Pernambuco

Status

Completed

Last Update Posted

Jun 15, 2022Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Uterine Cervical Neoplasms

Interventions

Extrafascial Hysterectomy
Modified radical hysterectomy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U1111-1176-6929	Other Identifier	UTN/WHO

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015Actual

Primary Completion Date

Apr 2018Actual

Completion Date

May 10, 2022Actual

First Submitted Date

Nov 20, 2015

First Submission Date that Met QC Criteria

Nov 23, 2015

First Posted Date

Nov 24, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2022

Last Update Posted Date

Jun 15, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Thales Paulo Batista, Consultant Physician and Researcher (Surgical Oncology), Hospital de Câncer de PernambucoPrincipal Investigator

Lead Sponsor

Hospital de Câncer de PernambucoOTHER

Collaborators

Name	Class
Santa Casa de Misericórdia de Maceió	OTHER
Professor Fernando Figueira Integral Medicine Institute	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Extrafascial Hysterectomy	Experimental	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
Modified radical hysterectomy	Active Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Extrafascial Hysterectomy	Procedure	Hysterectomy plus Pelvic Lymph-Node Dissection	Extrafascial Hysterectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Disease Free Survival (3-y DFS)	Time from surgery to recurrence	3 years

Secondary Outcomes

Measure	Description	Time Frame
Treatment-related adverse events (surgical)	Surgical morbidity and mortality	90 days
Patient reported QoL	QoL according to EORTC C30 questionnaire (v3.0)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36696980	Derived	Carneiro VCG, Batista TP, Andrade MR, Barros AV, Camara LHLD, Ramalho NM, Lucena MA, Fontao DFS, Tancredi R, Silva Junior TC, Bezerra ALR, Baiocchi G. Proof-of-concept randomized phase II non-inferiority trial of simple versus type B2 hysterectomy in early-stage cervical cancer </=2 cm (LESSER). Int J Gynecol Cancer. 2023 Apr 3;33(4):498-503. doi: 10.1136/ijgc-2022-004092.

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site