Comparison of Pelvic Lymphadenectomy Versus Isolated Sentinel Lymph Node Biopsy Procedure for Early Stages of Cervical Cancers : a Randomized Multicenter Study With Evaluation of Medico-economic Impacts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 267
- 试验地点
- 2
- 主要终点
- Number of Participants with complications observed in the 2 arms during the per and post-operative period up to 6 months
研究概览
简要总结
Patients with early cervical cancer are usually treated with radical hysterectomy + pelvic lymph-node dissection. The study randomizes patients in 2 arms. The control arm is the classical surgical treatment including identification of the sentinel nodes, full pelvic lymph-node dissection and radical hysterectomy.
The experimental arm is only sentinel node identification + radical hysterectomy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 18 years of age or older,
- •Absence of contraindication to laparoscopy,
- •Uterine cervical carcinoma (every histological type except neuroendocrine),
- •Stage IA1 with lymphatic tumor space involvement (LVSI) or IA2 diagnosed on cervical conization; or stage IA2, IB1 or IIA detected by clinical examination, confirmed by biopsy and measured by the MRI, the highest diameter being lower to 4 cm (a preoperative brachytherapy is allowed for tumors 2 to 4 cm in diameter),
- •Negative pregnancy test for women able to procreate,
- •Having the French National Social Security
- •Signed informed consent
排除标准
- •Neuroendocrine carcinoma,
- •In situ carcinoma or stage IA1 without LVSI,
- •Maximal tumoral diameter measured by MRI more than 4 cm,
- •Stage IB1 by "down-staging",
- •Stage IB2, IIB to IVB, including those who had a response to neoadjuvant treatment (chemotherapy or RT + chemotherapy) ,
- •Presence of distant metastases,
- •Progression of the cervical cancer or recurrence,
- •History of pelvic lymphadenectomy,
- •Other cancer diagnosed during the course of treatment,
- •Contraindication to the injected products : allergy known to Patent Blue or rhenium sulfide,
- •History of severe allergy (history of Quincke's edema, anaphylactic shock),
- •Patient who does not understand, speak or write the French language,
- •Pregnant woman
研究组 & 干预措施
Strategy A
Only identification of sentinel nodes (without pelvic lymph-node dissection)
干预措施: only identification of sentinel nodes (without pelvic lymph-node dissection) (Procedure)
Strategy B
Identification of sentinel nodes + full pelvic lymph-node dissection
干预措施: identification of sentinel nodes + full pelvic lymph-node dissection (Procedure)
结局指标
主要结局
Number of Participants with complications observed in the 2 arms during the per and post-operative period up to 6 months
时间窗: 6 months after surgery
次要结局
- the sites of recurrence for each strategy(Day 1)
- the detection rate of the sentinel node technique in the 2 arms(Day 1)
- the false negative rate in the control arm(Day 1)
- Score of the questionnaire of quality of life at 30 days, 3 months and 6 months after surgery(30 days, 3 months and 6 months after surgery)
- the costs of both studied strategies(At the surgery until 6 months)
- Number of patients without 3 years-recurrence for each strategy(3 years after surgery)
- Number of patient treated by radio chemotherapy because of the presence of micrometastases in the sentinel node(30 days, 3 months and 6 months after surgery)