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临床试验/NCT03225443
NCT03225443Unknown不适用

Shanghai First Maternity and Infant Hospital

Shanghai First Maternity and Infant Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年9月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
The recurrence rate

研究概览

简要总结

Locally advanced cervical cancer (LACC) refers to the clinically cervical visible lesion with a diameter of > 4 cm, which has been considered as a high risk of early cervical cancer for a long time. Because of local bulk lesion of LACC, the risk of radical hysterectomy is pretty high and the radical effect commonly does not meet the satisfactory. Therefore, 1-3 course of neoadjuvant chemotherapy (NACT) were carried out before operation. However, nearly 20% of patients are not sensitive to NACT. Therefore NACT did not bring any benefits to radical surgery even to some extent delayed the treatment.

Traditional radiotherapy is also commonly used in the treatment of LACC, however ovarian function would be permanently destroyed especially for young patients, additionally radioactive complications to adjacent organs of cervical such as vagina, bladder and rectal also commonly happened, moreover sexual dysfunction after radiotherapy significantly affect the life quality of young patients.

Particle radiotherapy developed recently, has the advantages of short course of treatment and mild side effects, due to its special working mechanism, Bragg effect. So the amount of radiation in the tumor tissue is very extremely high, and in the adjacent tissue is quiet low, therefore the organs at risk were protected by avoiding unnecessary damage.

Based on these, we proposed the application of particle radiotherapy in LACC pre-operation, and comprehensively evaluated recent curative effect, complications and long-term follow-up between particle radiotherapy and NACT. Furthermore, the clinical significance and long-term application prospects about particle therapy were objectively assessed.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Pathological diagnosis: squamous carcinoma, adenocarcinoma, adenosquamous carcinoma
  • The pathological staging: IB2,IIA2

排除标准

  • Underwent surgery or radiation and chemotherapy

结局指标

主要结局

The recurrence rate

时间窗: 3 years after treatment

次要结局

  • mortality(3 years after treatment)
  • The transfer rate(3 years after treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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