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临床试验/NCT02697084
NCT02697084已完成不适用

Individual Following in Anal Cancer With PET/CT

Centre Antoine Lacassagne2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2014年11月1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
110
试验地点
2
主要终点
time of disease-free survival

研究概览

简要总结

Anal canal cancer is a relatively rare disease, representing 1.2% of digestive cancers and 6% of anorectal cancers. Incidence is less than 1/100 000 of the general population. However, the incidence has increased considerably over the past three decades. The main risk factors are HPV infections and smoking. Initial treatment comprises radiochemotherapy or radiotherapy alone, according to the patient's tumor stage and tolerance of chemotherapy. The choice of the most appropriate treatment strategy will condition the patient's prognosis. Consequently, early assessment of the initial extension of the tumor, its therapeutic response and relapses constitute determining factors in the management of the disease Despite the good results obtained, persistent disease is observed in 30% of cases and abdominal-pelvic salvage amputation can then prove effective in cases of local or loco-regional relapse. The great majority of relapses occur within 2 years after treatment. Reported prognostic survival factors are the T stage, size inferior or superior to 4 cm and inguinal or pelvic lymph node involvement.

The rules for follow-up are not substantiated by high levels of proof. Follow-up focuses principally on the clinical examination although the type and frequency of the paraclinical examinations are not backed by any consensus.

详细描述

Post-treatment 18-FDG PET scan at 2 months can prove useful to predict locoregional or metastatic recurrence in patients treated by radiochemotherapy or radiotherapy in the anal canal cancer setting. There appear to be an FDG intensity variable and a metabolic response criterion enabling establishment of two groups of patients: low recurrence risk versus high recurrence risk at 2 years.

研究设计

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

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

  • Consecutive inclusion of incident cases of anal canal cancer between November 2014 and May
  • These patients are volunteers and have signed informed consent.

排除标准

  • Presence of a nother cancer and specific treatment (chemotherapy, radiotherapy). Follow-up impossible during two years or more.
  • Refusal to submit to initial or post-treatment PET/CT.

结局指标

主要结局

time of disease-free survival

时间窗: 3 years

次要结局

  • best treatment response criterion: ratio (SUV or metabolic volume)(3 years)
  • best metabolic response measurement variable: Total Lesion Glycolysis (TLG)(3 years)
  • best metabolic response measurement variable: SUL peak(3 years)
  • best treatment response criterion: SUV or metabolic volume threshold(3 years)
  • best metabolic response measurement variable: SUVmean(3 years)
  • best metabolic response measurement variable: SUVmax(3 years)
  • best metabolic response measurement variable: Metabolic Total Volume (MTV)(3 years)
  • best treatment response criterion: complete or partial metabolic response according to EORTC or PERCIST criteria(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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