Table A1.
Dose Modifications
Adjustment | Hematologic Toxicities |
Nonhematologic Toxicities CTC Grade | % Dose of Chemotherapy | |
---|---|---|---|---|
ANC ×109/L | Platelets ×109/L | |||
Gemcitabine in the control arm and before combination therapy in the experimental arm | 1-< 1.5 | And/or 75-99 | And/or 3 | 75 |
< 1 | And/or < 50 | And/or 4 | Hold; restart at full recovery with 50% dose | |
Gemcitabine and radiation during combination therapy | 0.5-< 1 | And/or 50-99 | And/or 3 | Hold; restart at recovery (grade ≤ 2 toxicity) with 50% dose* |
Abbreviations: ANC, absolute neutrophil count; CTC, Common Toxicity Criteria.
The decision to hold both radiotherapy and gemcitabine instead of just gemcitabine was left to the investigator's discretion.