Uterine Cervical Neoplasms
Conditions
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.
Interventions
PROCEDUREExtrafascial Hysterectomy
Hysterectomy plus Pelvic Lymph-Node Dissection
PROCEDUREModified radical hysterectomy
Hysterectomy plus Pelvic Lymph-Node Dissection
Sponsors
Hospital de Câncer de Pernambuco
Santa Casa de Misericórdia de Maceió
Professor Fernando Figueira Integral Medicine Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Due to the surgical nature of the study, only participants were masked to treatment allocation
Intervention model description
Proof of concept design (phase II non-inferiority trial)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Free Survival (3-y DFS) | 3 years | Time from surgery to recurrence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-related adverse events (surgical) | 90 days | Surgical morbidity and mortality |
| Patient reported QoL | Base-line and 6 months. | QoL according to EORTC C30 questionnaire (v3.0) |
| Rates of using adjuvant therapy | 90 days | Cisplatin-based chemo-radiation or pelvic radiation alone (EBRT +/- intracavitary brachytherapy) indicated according to the #GOG92 and #GOG109 criteria |
| Overall survival (3-y OS) | 3 years | Time from surgery to death of any cause |
Outcome results
None listed