跳至主要内容
临床试验/NCT01339832
NCT01339832已完成不适用

Capecitabine and Oxaliplatin Prior and Concurrent to Preoperative Pelvic Radiotherapy in Patients With Locally Advanced Rectal Cancer: A Survival Analysis.

Hoffmann-La Roche0 个研究点目标入组 51 人开始时间: 2010年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
主要终点
Progression-free Survival

研究概览

简要总结

This observational study is a follow-up study of protocol ML18280. Survival data of patients who took part in and concluded study ML18280 will be collected for up to 5 years after LPLV of ML18270.

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

  • Patients who took part in and concluded study ML18280 according to protocol

排除标准

  • 未提供

结局指标

主要结局

Progression-free Survival

时间窗: Up to 5 years

Progression free survival (PFS) was measured from the date of first administration of study medication in ML18280 study to the date of progression or death, whatever the cause. In participants with measurable disease, progression was defined according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0. Participants with neither tumor recurrence nor death were censored at the last tumor assessment date they were known to have not progressed (last date of diagnostic procedure or diagnostic marker reported in the surveillance). PFS time in days was calculated as PFS \[days\]= date of tumor recurrence/death date of first intake + 1, if participant had tumor recurrence confirmed by diagnostic imaging or participant died, then PFS \[days\] =last diagnostic procedure/marker date- date of first intake+ 1, and if participant survived without tumor recurrence PFS time in months was calculated as PFS \[months\]= 12 \* PFS \[days\] /365.25

次要结局

  • Tumor Recurrence Rate (Local and Distant)(Up to 5 years)
  • Compliance to Diagnostic Procedures in Surveillance(Up to 5 years)
  • Incidence of Adverse Event (AE) and Serious Adverse Event (SAE)(Up to 5 years)
  • Overall Survival(Up to 5 years)
  • Type of Adjuvant Chemotherapy(Up to 5 years)
  • Length of Adjuvant Chemotherapy(Up to 5 years)
  • Long Term Side Effects(Up to 5 years)

研究者

申办方类型
Industry
责任方
Sponsor

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