Table 1.
Schedule of events
| Screening | Random allocation (a) | Treatment period | EOT | Surgery | EOS | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day -14 (b) | Day -7 | Day 1 (c) | Day 8 ± 3 days | Day 15 ± 3 days | Day 22 ± 3 days | Day 29 ± 3 days | Day 36 ± 3 days | Day 66 ± 3 days | Day 87–94 | 28 (+7) days after surgery | |||
| Informed consent | X | ||||||||||||
| Inclusion/exclusion criteria | X | X | |||||||||||
| Demographics | X | ||||||||||||
| Medical history | X | ||||||||||||
| Concomitant medications | X | X | X | X | X | X | X | X | X | X | X | ||
| Adverse events | X | X | X | X | X | X | X | X | X | ||||
| Physical examination | X | X | |||||||||||
| Vital signs | X | X | X | X | X | X | X | X | X | X | X | ||
| Weight | X | X | X | X | X | X | X | X | X | X | X | ||
| Height | X | ||||||||||||
| ECOG performance status | X | X | X | X | X | X | X | X | X | X | X | ||
| Electrocardiogram (12-lead) | X | X | X | ||||||||||
| MUGA | X | X | X | ||||||||||
| Hematology | X | X | X | X | X | X | X | X | X | X | X | ||
| Serum chemistries | X | X | X | X | X | X | X | X | X | X | X | ||
| Hemostasis | X | ||||||||||||
| Pregnancy test | X | X | X | ||||||||||
| CT – scan (chest, abdomen, pelvis) | X | ||||||||||||
| Endoscopic ultrasound | X | ||||||||||||
| Tumor sampling | X | X(c) | X | ||||||||||
| Lapatinib (arm A) | 1 250 mg/d until the last day of radiotherapy | ||||||||||||
| Capecitabine (arms A and B) | 825 mg/m2 twice daily from first to last day of radiotherapy | ||||||||||||
| Radiation therapy | 50.4 Gy in 28 fractions of 1.8 Gy, 5 days per week | ||||||||||||
EOT end of treatment visit, EOS end of study visit
(a) Within 4 weeks of screening visit
(b) Not more than 3 days before day -14 in arm A or more than 14 days before day 1 in arm B. In arm B, random allocation visit procedures are valid for day 1 visit if <7 days have elapsed
(c) Arm A only: to be performed within a 3-day time window of day 1 of radiation treatment