The staging was according to AJCC Cancer Staging Manual 6th edition [ 6]; Based on this staging, all the patients who need adjuvant chemotherapy received the 5-FU-based regimen, and the basic regimen was FOLFOX6 or XELOX.
However, therapeutic decisions should not be based on this staging system as in non-cirrhotic patients curative treatment can be offered also to patients with large intrahepatic tumors outside the Milan criteria.
And, if there were differences in the interim analysis, we wanted to reassume the RFS of the control arm based on this stage distribution of the study population, and subsequently the sample size required to detect the efficacy of the experimental arm.
Stage was based on TNM staging groups [ 38].
We have demonstrated that this approach has resulted in an improvement in survival of patients treated with radical radiotherapy compared to a comparable cohort of patients receiving this therapy based on conventional staging [ 16].
Three stages based on Tanner stages: 'prepubertal' equals G/M1&P1; 'postpubertal' equals G/M5&P5; 'pubertal' equals all other Tanner stages.
The clinical TNM stage was determined based on these staging results.
The mortality factors are distributed thorughout the stages based on the stages characteristics according to Table 4, 5 and 6.
If by doing that, a new point is found, it would rerun the second stage based on this new point.
For this cancer type, further subgrouping based on stage may be needed, as reported [ 43].
