LESs Surgical Radicality for EaRly Stage Cervical Cancer

Uterine Cervical Neoplasms Clinical Trial

— LESSER  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02613286
• Other study ID #: CAAE: 42981715.7.0000.5205
• Secondary ID: U1111-1176-6929
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: May 10, 2022

Study information

• Verified date: June 2022
• Source: Hospital de Câncer de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 10, 2022
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Uterine Cervical Neoplasms

Intervention

Procedure:
• Extrafascial Hysterectomy
Hysterectomy plus Pelvic Lymph-Node Dissection
• Modified radical hysterectomy
Hysterectomy plus Pelvic Lymph-Node Dissection

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Hospital de Câncer de Pernambuco	Professor Fernando Figueira Integral Medicine Institute, Santa Casa de Misericórdia de Maceió

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Free Survival (3-y DFS)	Time from surgery to recurrence	3 years
Secondary	Treatment-related adverse events (surgical)	Surgical morbidity and mortality	90 days
Secondary	Patient reported QoL	QoL according to EORTC C30 questionnaire (v3.0)	Base-line and 6 months.
Secondary	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
Secondary	Overall survival (3-y OS)	Time from surgery to death of any cause	3 years

External Links

•   Oral Abstracts Farr Nezhat Surgical Innovation Session 60 - Education Forum, SGO 2021