Table 1.
Characteristic | Clinical Trials Group, National Cancer Institute of Canada | North Central Cancer Treatment Group | Gastrointestinal Intergroup, National Cancer Institute | Fondation Française de Cancérologie Digestive | |
---|---|---|---|---|---|
Protocol 784852 | Protocol 874651 | ||||
Details of trial | |||||
| |||||
Date of first randomization | May 1987 |
May 1978 |
February 1988 |
January 1985 |
October 1982 |
| |||||
Total no. of patients randomized | 370 | 267 | 111 | 936 | 268 |
| |||||
Total no. of samples collected and analyzed for microsatellite-instability status | 292 | 66 | 34 | 143 | 35 |
| |||||
Eligibility criteria | |||||
| |||||
Age limit | None | None | None | None | ≤75 yr |
| |||||
Minimum no. of days between surgery and beginning of chemotherapy | 56 | 35 | 35 | 35 | 35 |
Adjuvant chemotherapy | |||||
| |||||
Dose of fluorouracil (mg/m2)† | 370 | 450 | 425 | 450 | 400 |
| |||||
Dose of leucovorin (mg/m2)† | 200 | — | 20 | — | 200 |
| |||||
Dose of levamisole (mg/m2)† | — | 50 | — | 50 | — |
| |||||
Duration of therapy (mo) | 6 | 12 | 6 | 12 | 6 |
| |||||
Median follow-up (yr) | 6.2 | 11.6 | 7.8 | 8.8 | 4.9 |
Modified from the International Multicentre Pooled Analysis of Colon Cancer Trials (IMPACT) Investigators.4
The doses are given as milligrams per square meter of body-surface area.