Clinical trial NCT02613286: LESs Surgical Radicality for EaRly Stage Cervical Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Cervical Neoplasms
Lead sponsor: Hospital de Câncer de Pernambuco
Sponsor class: OTHER
Collaborators: name: Santa Casa de Misericórdia de Maceió
name: Professor Fernando Figueira Integral Medicine Institute
First posted: 2015-11-24
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Proof of concept design (phase II non-inferiority trial)
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Disease Free Survival (3-y DFS)
timeFrame: 3 years
Secondary outcomes:
measure: Treatment-related adverse events (surgical)
timeFrame: 90 days
measure: Patient reported QoL
timeFrame: Base-line and 6 months.
measure: Rates of using adjuvant therapy
timeFrame: 90 days
measure: Overall survival (3-y OS)
timeFrame: 3 years
Other outcomes:
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