LESs Surgical Radicality for EaRly Stage Cervical Cancer (LESSER)

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

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.

Study Overview

• Status: Completed
• Conditions: Uterine Cervical Neoplasms
• Intervention / Treatment: Procedure: Extrafascial Hysterectomy; Procedure: Modified radical hysterectomy

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: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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)	Base-line and 6 months.
Rates of using adjuvant therapy	Cisplatin-based chemo-radiation or pelvic radiation alone (EBRT +/- intracavitary brachytherapy) indicated according to the #GOG92 and #GOG109 criteria	90 days
Overall survival (3-y OS)	Time from surgery to death of any cause	3 years

Collaborators and Investigators

• Sponsor: Hospital de Câncer de Pernambuco
• Collaborators: Professor Fernando Figueira Integral Medicine Institute; Santa Casa de Misericórdia de Maceió

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2015
• Primary Completion (ACTUAL): April 1, 2018
• Study Completion (ACTUAL): May 10, 2022

Study Registration Dates

• First Submitted: November 20, 2015
• First Submitted That Met QC Criteria: November 23, 2015
• First Posted (ESTIMATE): November 24, 2015

Study Record Updates

• Last Update Posted (ACTUAL): June 15, 2022
• Last Update Submitted That Met QC Criteria: June 13, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: CAAE: 42981715.7.0000.5205; U1111-1176-6929 (OTHER: UTN/WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO