NCT02613286

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 24, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2022

Completed
Last Updated

June 15, 2022

Status Verified

June 1, 2022

Enrollment Period

2.9 years

First QC Date

November 20, 2015

Last Update Submit

June 13, 2022

Conditions

Uterine Cervical Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Disease Free Survival (3-y DFS)

    Time from surgery to recurrence

    3 years

Secondary Outcomes (4)

  • Treatment-related adverse events (surgical)

    90 days

  • Patient reported QoL

    Base-line and 6 months.

  • Rates of using adjuvant therapy

    90 days

  • Overall survival (3-y OS)

    3 years

Study Arms (2)

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

Extrafascial HysterectomyPROCEDURE

Hysterectomy plus Pelvic Lymph-Node Dissection

Extrafascial Hysterectomy
Modified radical hysterectomyPROCEDURE

Hysterectomy plus Pelvic Lymph-Node Dissection

Modified radical hysterectomy

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 36696980DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Due to the surgical nature of the study, only participants were masked to treatment allocation
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Proof of concept design (phase II non-inferiority trial)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Physician and Researcher (Surgical Oncology)

Study Record Dates

First Submitted

November 20, 2015

First Posted

November 24, 2015

Study Start

May 1, 2015

Primary Completion

April 1, 2018

Study Completion

May 10, 2022

Last Updated

June 15, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share