NL-OMON49363招募中不适用
The RACC trial -Robot-assisted Approach to Cervical Cancer. A multi-centre open-label randomised non-inferiority trial of robotassisted laparoscopic surgery versus laparotomy in women with early stage cervical cancer. - RACC-trial
Karolinska University Hospital0 个研究点目标入组 200 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Histologically confirmed primary adenocarcinoma, squamous cell carcinoma or
- •adenosquamous
- •carcinoma of the uterine cervix;
- •Women with histologically confirmed FIGO stage IB (IB3 excluded) and IIA1
- •Women undergoing either a Type B or C radical hysterectomy according to
- •Morrow classification
- •ECOG Performance Status of 0, 1 or 2
- •Patient must be suitable for surgery.
- •Patients who have signed an approved Informed Consent
- •Age> 18 years
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, estimated by either magnetic resonance imaging
- •clinical examination
- •FIGO stage II-IV (except IIA1)
- •Women with a history of pelvic or abdominal radiotherapy
- •Women who are pregnant
- •Women with contraindications to surgery
- •Women with evidence of metastatic disease by conventional imaging studies,
- •pelvic or aortic lymph nodes > 2cm; or histologically positive lymph nodes
- •Serious concomitant systemic disorders incompatible with surgery or study (at
- •discretion of the investigator)
- •Women unable to withstand prolonged lithotomy and steep Trendelenburg position
- •Women with secondary invasive neoplasm in the last 5 years (except
- •non-melanoma
- •skin cancer, breast cancer T1 N0 M0 grade 1 or 2 without any signs of
- •recurrence or
- •Women with iodine allergy cannot be part of the sentinel node part of the
- •trial but are
- •allowed randomisation as to the primary outcome
研究者
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