A Prospective Observational Trial on Sentinel Lymph Node Biopsy in Patients With Early Stage Cervical Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Recurrence rate at the 24th month of follow-up (cervical recurrences after fertility-sparing procedures will be excluded)
研究概览
简要总结
To evaluate whether a less radical surgical approach with sentinel lymph node biopsy is non-inferior to treatment with systematic pelvic lymphadenectomy.
The null hypothesis is that the recurrence rate after SLN biopsy is non-inferior to the reference recurrence rate of 7 % (at the 24th month of follow-up) in patients after systematic pelvic lymphadenectomy, but that the less radical surgery is associated with significantly lower postoperative morbidity.
详细描述
Patients will be enrolled in the study at the time of surgery planning; at this point, a patient´s consent will be requested if inclusion criteria are fulfilled (histological type, FIGO stage, age, performance status, lymph node clinical status). The following procedures will be provided prior to surgery: clinical staging (MRI or EUS), medical data collection, adverse events assessment, lymphedema assessment, quality of life questionnaire, ECOG performance status, weight and height, standard pre-operative laboratory workup, pregnancy test if clinically indicated.
Surgery should be done within 6 weeks of the imaging study (MRI or expert US). During the surgery, local or distant cancer spread outside of the cervix will be excluded, SLN will be detected, and all SLN will be sent for intra-operative pathologic evaluation. In patients with SLN detection on both sides of the pelvis no other lymph nodes will be removed and they will continue in the study. SLN biopsy will be followed by radical hysterectomy (type B, C1, or C2) or fertility-sparing procedure, according to the pre-operative plan.
Intra-operatively, three groups of patient will be excluded from the SLN study group (though they can be included in the control group):
- Patients with intra-operative detection of more advanced disease stage (> IB1)
- Patients with failure to detect SLN bilaterally (either no SLN detected or only on one side of the pelvis)
- Patients with intra-operative pathologic detection of macrometastases or micrometastases in SLN
In these patients who were excluded from the study group, further surgery and adjuvant treatment will be provided according to the institutional guidelines. These patients will remain in a database and reasons for their exclusion from the SLN study group will be entered into the SIS (Form 2).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Neoadjuvant chemotherapy
- •History of pelvic or abdominal radiotherapy
- •HIV positivity / AIDS
- •Adenosquamous cancer or adenocarcinoma unusual type (non HPV related - such as: mucinous, clear cell, mesonephric)
- •II) Control Group:
- •Inclusion criteria:
- •A) Preoperative:
- •FIGO stage IA1 + LVSI; IA2; IB
- •Performance status ECOG: 0-1
- •Age ≥ 18 years, ≤ 75 years
- •Patient is not pregnant
- •No history of pelvic or abdominal radiotherapy
- •Patient scheduled for surgical treatment including systematic pelvic lymphadenectomy
- •Approved and signed Informed Consent
- •B) Intra-operative:
- •a) Systematic pelvic lymphadenectomy performed at least on one side of the pelvis
- •Exclusion criteria:
- •History of pelvic or abdominal radiotherapy
结局指标
主要结局
Recurrence rate at the 24th month of follow-up (cervical recurrences after fertility-sparing procedures will be excluded)
时间窗: 24 months
Recurrence rate (RR) will be estimated at the 24th month of follow-up to prove a non-inferiority of SLN biopsy to the reference value (RR 24th month: 7 %).
次要结局
- Prevalence of lower extremity lymphedema(2 years)
- DFS (Disease-free survival)(2 years)
- Quality of life (QoL)(1 year)
- FNR (False Negative Rate) of intra-operative pathologic SLN evaluation(2 years)
- Prevalence of symptomatic pelvic lymphocele(2 years)
- DFS in SLN negative patients(2 years)
- Pelvic DFS (Pelvic Disease-free survival)(2 years)
- Recurrence rate safety margins(2 years)
- Postoperative morbidity(2 years)
- Intra-operative morbidity(1 month)
- Overall survival(2 years)
研究者
David Cibula
MD, PhD, Professor
Charles University, Czech Republic