LESs Surgical Radicality for EaRly Stage Cervical Cancer

NCT ID: NCT02613286

Last Updated: 2022-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2022-05-10

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.

Conditions

Uterine Cervical Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Extrafascial Hysterectomy

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

Group Type: EXPERIMENTAL

Extrafascial Hysterectomy

Intervention Type: PROCEDURE

Hysterectomy plus Pelvic Lymph-Node Dissection

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.

Group Type: ACTIVE_COMPARATOR

Modified radical hysterectomy

Intervention Type: PROCEDURE

Hysterectomy plus Pelvic Lymph-Node Dissection

Interventions

Extrafascial Hysterectomy

Hysterectomy plus Pelvic Lymph-Node Dissection

Intervention Type: PROCEDURE

Modified radical hysterectomy

Hysterectomy plus Pelvic Lymph-Node Dissection

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Santa Casa de Misericórdia de Maceió

OTHER

Sponsor Role: collaborator

Professor Fernando Figueira Integral Medicine Institute

OTHER

Sponsor Role: collaborator

Hospital de Câncer de Pernambuco

OTHER

Sponsor Role: lead

Responsible Party

Thales Paulo Batista

Consultant Physician and Researcher (Surgical Oncology)

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 36696980 (View on PubMed)

Other Identifiers

U1111-1176-6929

Identifier Type: OTHER

Identifier Source: secondary_id

CAAE: 42981715.7.0000.5205

Identifier Type: -

Identifier Source: org_study_id