Robot-assisted Approach to Cervical Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Recurrence-free survival
研究概览
简要总结
The purpose of the RACC trial is to compare the oncologic outcome defined as recurrence-free survival (RFS) between robot-assisted and open radical hysterectomy for the treatment of early stage cervical cancer.
详细描述
BACKGROUND Cervical cancer is one of the most common female malignancies worldwide, with the largest proportion of women affected in low income countries. Radical hysterectomy with pelvic lymphadenectomy constitutes the primary treatment of early stage cervical cancer. Surgery has traditionally been performed by laparotomy but the past 20 years, the use of minimally invasive techniques has increased. Several studies suggest that laparoscopic radical hysterectomy is associated with less preoperative morbidity and superior quality of life.
In 2005, the Food and Drug Administration (FDA) approved robot-assisted surgery for gynaecological indications. Observational studies have confirmed advantages in form of shorter hospital stay, less bleeding and acceptable OT. Furthermore, compared to conventional laparoscopy OT is significantly shorter with robot technique. Despite wide acceptance and implementation of the robotic system into gynecological oncology todate there are mainly retrospective observational data published on oncological outcomes, offering a low evidence level.
The sentinel node biopsy concept (SNB) is well established in the surgical management of several malignancies including breast, melanoma and vulvar cancer. Theoretically, the implementation would change the management of patients with early cervical cancer dramatically by avoiding multimodal treatment.
Traditionally, radiotracers (Technetium) with or without augmentation of blue dye have been used for SNB. Novel tracers such as fluorescent dyes (indocyanine green (ICG)) have been demonstrated to be superior.
Apart from detection rate, the rate of bilateral mapping of sentinel nodes and sensitivity (false negative rate included), constitutes the most important aspect of the technique. In recent ESGO guidelines on the management of stage IA disease SNB is recommended as the standard treatment unless in patients with positive LVSI where complete PLND should be considered.
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
- •Histologically confirmed primary adenocarcinoma, squamous cell carcinoma or adeno-squamous carcinoma of the uterine cervix;
- •Patients with histologically confirmed stage IB (IB3 excluded) and IIA1, according to the latest revision of the FIGO staging manual
- •Patients undergoing either a Type B or C radical hysterectomy (Querleu and Morrow classification)
- •Patients with adequate bone marrow, renal and hepatic function
- •ECOG Performance Status of 0, 1 or
- •Patient must be suitable candidates for surgery.
- •Patients who have signed an approved Informed Consent
- •Age 18 years or older
排除标准
- •Any histology other than adenocarcinoma, squamous cell carcinoma or adeno-squamous carcinoma of the uterine cervix
- •Tumor size greater than 4 cm
- •FIGO stage II-IV (except IIA1)
- •Patients with a history of pelvic or abdominal radiotherapy
- •Patients who are pregnant
- •Patients with contraindications to surgery
- •Patients with evidence of metastatic disease by conventional imaging, enlarged pelvic or aortic lymph nodes > 2cm; or histologically positive lymph nodes
- •Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
- •Patients unable to withstand prolonged lithotomy and steep Trendelenburg position
- •Patients with secondary invasive neoplasm in the last 5 years (except non-melanoma skin cancer, breast cancer T1N0M0 grade 1 or 2 without any signs of recurrence or activity)
研究组 & 干预措施
Abdominal radical hysterectomy
Total radical hysterectomy with Sentinel lymph node biopsy followed by completion pelvic lymphadenectomy
干预措施: Abdominal radical hysterectomy (Procedure)
Abdominal radical hysterectomy
Total radical hysterectomy with Sentinel lymph node biopsy followed by completion pelvic lymphadenectomy
干预措施: Sentinel lymph node biopsy (Diagnostic Test)
Robot-assisted radical hysterectomy
Total radical hysterectomy with Sentinel lymph node biopsy followed by completion pelvic lymphadenectomy
干预措施: Robot-assisted radical hysterectomy (Procedure)
Robot-assisted radical hysterectomy
Total radical hysterectomy with Sentinel lymph node biopsy followed by completion pelvic lymphadenectomy
干预措施: Sentinel lymph node biopsy (Diagnostic Test)
结局指标
主要结局
Recurrence-free survival
时间窗: 60 months from surgery
Time-interval between the date of randomisation and the date of recurrence or the date of death
次要结局
- Overall survival(60 months from surgery)
- Intraoperative complications: number of participants with bowel injuries, urinary tract injuries, hemorrhage requiring vessel suture and/or transfusion, nerve injuries(Complications occurring during intervention (intraoperatively))
- Post-operative complications: Number of participants requiring pharmacological treatment (CD II) OR surgical, endoscopic or radiological intervention (CD III) OR life-threatening complications requiring ICU-management (CD IV) OR death (CD V)(Postoperative complications are assessed at 30 days postoperatively and at 6 months postoperatively)
- Health-related quality of life (HRQoL) after surgery for early stage cervical cancer using European Organisation for Research and Treatment of Cancer Quality of Life Cancer Patients (EORTC-QLQ).(Before randomisation, 1 month post surgery, 6 months post surgery, 12 months post surgery, 24 months post surgery, 60 months post surgery)
- Sentinel lymph node biopsy in cervical cancer(Through study completion, an average of 5 years)
- Health care costs(6 months from surgery)
研究者
Henrik Falconer
Head of GYN Oncology
Karolinska Institutet