Table 1 Synopsis of the main characteristics of the trials before and after merging
IRE trial | GOCSI-GruCOS trial | IGCS-COL trial | |
|---|---|---|---|
Main questions | (1) Efficacy of adjuvant PVI | (1) Efficacy of 5FU modulation with LEV | (1) Efficacy of 5FU modulation with LEV |
(2) Efficacy of 5FU modulation with FA | (2) Efficacy of 5FU modulation with FA | (2) Efficacy of 5FU modulation with FA | |
Patients included | Colon cancer, TNM stage II or III; age 18–75 years; PS 0–2 | Colon or rectal cancer, TNM stage II or III; age 18–75 years; PS 0–2 | Colon or rectal cancer, TNM stage II or III; age 18–75 years; PS 0–2 |
Study design | Phase 3, 2 × 2 factorial design | Phase 3, 2 × 2 factorial design | Phase 3, 2 × 2 factorial design |
Portal vein chemotherapy | Mitomycin C+5FU | None | None |
Systemic chemotherapy | 5FU+LEV | 5FU | 5FU |
5FU+LEV+PVI | 5FU+LEV | 5FU+LEV | |
5FU+LEV+FA | 5FU+FA | 5FU+FA | |
5FU+LEV+FA+PVI | 5FU+LEV+FA | 5FU+LEV+FA | |
Randomisation | Centralised, during surgery, stratified by centre | Centralised, after surgery, stratified by tumour site and stage | Centralised, after surgery, stratified by tumour site and stage |
Duration of systemic chemotherapy | 6 months | 12 months | 6 months |
Timing of follow-up | Every 3 months for years 1–2, every 6 months for years 3–10, annually thereafter | Every 3 months for years 1–2, every 6 months for years 3–10, annually thereafter | Every 3 months for years 1–2, every 6 months for years 3–10, annually thereafter |
Time of accrual | March 1991–August 1993 | March 1991–August 1993 | September 1993–1998 |
