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临床试验/NCT05201105
NCT05201105已完成不适用

Tumor Recurrence After Abdominal-perineal Amputation in Squamous Cell Carcinoma of the Anus

Fondation Hôpital Saint-Joseph1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2021年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
1
主要终点
Recurrence-free survival after abdominal-perineal amputation in case of failure of radiochemotherapy

研究概览

简要总结

Squamous cell carcinoma of the anal canal is a rare cancer with an increasing incidence. It represents 2.5% of digestive cancers and occurs more frequently in immunocompromised persons, in particular HIV positive. It is a cancer that develops essentially locally, with only 5% of metastases at diagnosis. The reference treatment for forms deemed localized after clinico-bio-radiological pre-therapeutic evaluation is radiochemotherapy allowing a 5-year survival rate of about 80%. However, up to 30% of patients fail radiochemotherapy. Failure is defined as persistent disease (non response or progression in 10 to 15% of patients) or relapse (local or metastatic in 10 to 15% of patients). Salvage surgery by abdominoperineal amputation is indicated in this case after elimination of the metastatic character with an overall survival rate at 5 years varying from 23 to 69%. This complex and cumbersome surgery is burdened with significant postoperative morbidity with alteration of the quality of life. Investigators would like to perform a retrospective and prospective study in the Paris Saint-Joseph hospital group to evaluate the interest of abdominoperineal amputation in case of failure of radiochemotherapy in patients with squamous cell carcinoma of the anal canal.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with abdominoperineal amputation for squamous cell carcinoma of the anus
  • Patient whose age ≥ 18 years
  • French speaking patient

排除标准

  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under court protection
  • Patient objecting to the use of his data for this research

结局指标

主要结局

Recurrence-free survival after abdominal-perineal amputation in case of failure of radiochemotherapy

时间窗: Week 26

This outcome corresponds to the Recurrence-free survival (local, metastatic) after abdominal and perineal amputation in case of failure of radio chemotherapy.

次要结局

  • Overall survival after abdominal-perineal amputation(Year 2)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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