Feasibility Study: Conservative Treatment in Cervical Cancer FIGO Stage IB1-IIA1 > 2cm
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- pregnancy rate
研究概览
简要总结
Currently conservative treatment for patients of childbearing affected by cervical cancer is reserved for women with FIGO stage IA2 - IB1 with tumor size less than 2 cm . The trachelectomy and the cone biopsy with pelvic lymphadenectomy are the choice for these patients wishing to preserve their reproductive function.
In this context , recently literature show the results about the use of neo-adjuvant chemotherapy about the reduction of tumor volume and therefore the magnitude of the subsequent surgical treatment (including patients with tumors larger than 2 cm ). So it becomes crucial a prospective analysis on the possibility to include in this type of treatment patients with stage IB1 and IIA1 with tumor size greater than 2 cm ( up to 4 cm ) .
The current study , in fact , would like to do a prospective evaluation on the advantages of neo-adjuvant chemotherapy in the possibility of broadening the inclusion criteria to conservative treatment in women , suffering from cervical cancer, stage IB1 and IIA1 ( with tumor volume between 2 and 4 cm) and wishing to preserve their reproductive function.
详细描述
The investigators would like to be conservative in young patients affected by early stage cervical cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Squamous cervical cancer or adenocarcinoma in FIGO stage IB1-IIA, tumor volume between > 2 and ≤ 4 cm (instrumental evaluation).
- •Informed consensus
- •Childbearing
- •Fertility (through US and ormonal withdrawal pre - e post neoadjuvant chemotherapy
- •ASA (American Society of Anesthesiologist) Class < 2
排除标准
- •ongoing pregnancy
研究组 & 干预措施
conservative treatment in cervix cancer
we performed conservative treatment cervix cancer patients with IB FIGO stage without pelvic involvement
干预措施: conservative treatment (Procedure)
结局指标
主要结局
pregnancy rate
时间窗: 3 years
time of pregnancy. Case of miscarriage, pre-term delivery or full term delivery.
次要结局
- Overall survival(5 years)
- disease free survival(5 years)
研究者
Prof. Giovanni Scambia
Feasibility Study: Conservative Treatment in Cervical Cancer FIGO Stage IB1-IIA1 > 2cm
Catholic University of the Sacred Heart
