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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Disease Free Survival (3-y DFS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Due to the surgical nature of the study, only participants were masked to treatment allocation
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed adenocarcinoma, squamous, or adenosquamous cancer of the cervix by LEEP, cone or cervical biopsy;
- •Aged between 18 and 70 years;
- •performance status 0-2 (ECOG, Eastern Cooperative Oncology Group) and / or greater than 70 points by the Karnofsky scale;
- •FIGO early stage IA2-IB1 ≤ 2cm;
- •Appropriated cardio-respiratory, hepato-renal and hematological reserves; and
- •Signing of the Consent Form.
排除标准
- •Limiting systemic comorbidities including neuro-psychiatric disorders or obesity;
- •Apparent or confirmed uncontrolled infections;
- •Other malignancies in activity;
- •Previous radiation or chemotherapy treatment or major pelvic surgery;
- •History of drug allergies, and pregnancy or breast feeding; and
- •Evidence of more extensive disease at the time of surgery.
研究组 & 干预措施
Extrafascial Hysterectomy
Type A hysterectomy with 1 - 2cm of vaginal cuff plus level 1 pelvic lymph-node dissection according to Querleu and Morrow classification.
干预措施: Extrafascial Hysterectomy (Procedure)
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.
干预措施: Modified radical hysterectomy (Procedure)
结局指标
主要结局
Disease Free Survival (3-y DFS)
时间窗: 3 years
Time from surgery to recurrence
次要结局
- Treatment-related adverse events (surgical)(90 days)
- Patient reported QoL(Base-line and 6 months.)
- Overall survival (3-y OS)(3 years)
- Rates of using adjuvant therapy(90 days)
研究者
Thales Paulo Batista
Consultant Physician and Researcher (Surgical Oncology)
Hospital de Câncer de Pernambuco