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临床试验/NCT02323841
NCT02323841Unknown早期 1 期

Feasibility Study: Conservative Treatment in Cervical Cancer FIGO Stage IB1-IIA1 > 2cm

Catholic University of the Sacred Heart2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年3月最近更新:
适应症
干预措施

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

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Giovanni Scambia

Feasibility Study: Conservative Treatment in Cervical Cancer FIGO Stage IB1-IIA1 > 2cm

Catholic University of the Sacred Heart

研究点 (2)

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