DIGEST: Diffuse Gastric and Esophagogastric junction cancer S-1 Trial

• Research type

  Research Study

• Full title

  AN OPEN-LABEL, MULTICENTER, RANDOMIZED, PHASE 3 STUDY OF S-1 AND CISPLATIN COMPARED WITH 5-FU AND CISPLATIN IN PATIENTS WITH METASTATIC DIFFUSE GASTRIC CANCER PREVIOUSLY UNTREATED WITH CHEMOTHERAPY

• IRAS ID

  61718

• Sponsor organisation

  Taiho Pharma USA, Inc.

• Eudract number

  2009-016019-39

• Research summary

  Gastric cancer is the fourth most common cancer worldwide, behind lung, breast, and colorectal cancers; and is the second most common cause of cancer-related death, with an estimate of 700,000 deaths annually. Currently, patients with gastric cancer can be cured only when diagnosed with early stage disease in which a complete surgical removal of the tumour can be achieved. However, only 20% of patients diagnosed with gastric cancer have localized disease and the relative 5-year survival rate for gastric cancer of all stages is only 22%.During the last decades it has been demonstrated thafluropyrimidine-based and platinum-based regimens are cornerstones of chemotherapy of patients with advanced gastric cancer.S-1 is a new drug that was developed to provide more efficacious and safer oral delivery of flurouracil (5-FU) to gastric tumour cells. The purpose of this study is to determine the safety of S-1 and how effective S-1 combined with cisplatin is in treating metastatic gastric cancer (diffuse type) compared to standard treatment with 5-FU combined with cisplatin.Approximately 500 patients with diffuse type metastatic gastric cancer, from 20 countries around the world, are expected to participate in this trial. Patients will be randomly assigned to either treatment with S-1 combined with cisplatin (experimental treatment) or 5-FU combined with cisplatin (control treatment).

• REC name

  Scotland A REC

• REC reference

  11/AL/0120

• Date of REC Opinion

  11 May 2011

• REC opinion

  Further Information Favourable Opinion