LESs Surgical Radicality for EaRly Stage Cervical Cancer (LESSER)

Hospital de Câncer de Pernambuco

Status: Completed

Conditions: Uterine Cervical Neoplasms

Treatments: Procedure: Modified radical hysterectomy; Procedure: Extrafascial Hysterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02613286

CAAE: 42981715.7.0000.5205

U1111-1176-6929 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Extrafascial Hysterectomy

Experimental group

Description:

Type A hysterectomy with 1 - 2cm of vaginal cuff plus level 1 pelvic lymph-node dissection according to Querleu and Morrow classification.

Treatment:

Procedure: Extrafascial Hysterectomy

Modified radical hysterectomy

Active Comparator group

Description:

Type B2 hysterectomy with 1 - 2cm of vaginal cuff plus level 1 pelvic lymph-node dissection according to Querleu and Morrow classification.

Treatment:

Procedure: Modified radical hysterectomy