An Observational Study of Xeloda (Capecitabine) and Oxaliplatin Prior and Concurrent To Preoperative Pelvic Radiotherapy in Patients With Locally Advanced Rectal Cancer

Arms (1)

1. label

   Cohort

Primary outcomes (1)

1. measure

   Progression-free Survival

   timeFrame

   Up to 5 years

   description

   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