| Trial name or title |
Effectiveness of first line treatment with lapatinib and ECF/X in histologically proven adenocarcinoma of the stomach or the esophagogastric junction, metastatic or not amenable to curative surgery according to HER2 and EGFR status: a randomized Phase II trial |
| Methods |
RCT |
| Participants |
Patients with histologically‐confirmed adenocarcinoma of the stomach or the esophago‐gastric junction; metastatic disease OR not amenable to curative surgery; tissue material for HER2 and EGFR assessment must be available; positive HER2 status by IHC OR positive EGFR by either FISH or IHC at time of randomization; no clinical signs of CNS involvement; no prior palliative systemic chemotherapy |
| Interventions |
Experimental: chemotherapy (capecitabine + cisplatin + epirubicin hydrochloride + fluorouracil) + lapatinib Placebo comparator: chemotherapy (capecitabine + cisplatin + epirubicin hydrochloride + fluorouracil) + placebo |
| Outcomes |
PFS; response rate; OS; toxicity; concordance of diagnostic tests |
| Starting date |
May 13 2010 |
| Contact information |
Not available |
| Notes |
This study has been terminate since the company withdrew interest |
