Diffuse Gastric and Esophagogastric Junction Cancer S-1 Trial (DIGEST)

Taiho Pharma

Status and phase: Terminated; Phase 3

Conditions: Metastatic Diffuse Gastric Cancer Including Carcinoma of the Gastro-esophageal Junction

Treatments: Drug: S-1 (Tegafur+Gimeracil+Oteracil) /cisplatin (investigational arm); Drug: Fluorouracil/cisplatin (control arm)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01285557

TPU-S1303

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of S-1 and Cisplatin compared to 5-FU and Cisplatin in treatment of patients with metastatic diffuse gastric and gastro-esophageal junction cancer previously untreated with chemotherapy.

Full description

This is an open-label, international, Phase 3 study evaluating the efficacy and safety of the S-1/cisplatin regimen versus the 5-FU/cisplatin regimen in chemotherapy-naïve patients with metastatic diffuse gastric carcinoma including carcinoma of the gastro-esophageal junction. Patients will be randomly assigned to S-1/cisplatin (experimental regimen, Arm A) or 5-FU/cisplatin (control regimen, Arm B).

Enrollment: 361 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has given written Informed Consent.
• Histologically confirmed, unresectable, metastatic diffuse gastric cancer including carcinoma of the gastro-esophageal junction.
• No prior chemotherapy for gastric cancer except adjuvant and/or neo-adjuvant chemotherapy more than 12 months ago.
• Life expectancy of at least 3 months.
• Able to take medications orally.
• Eastern Cooperative Oncology Group performance status 0 to 1.
• Adequate organ function (bone marrow, kidney and liver).

Exclusion criteria

• Certain type(s) of non-measurable lesion(s), if the only one(s).
• Certain serious illness or medical condition(s).
• Lost greater than or equal to 10% of body weight in the 3 months proceeding signing the Informed Consent Form.
• Treatment with drugs interacting with S-1, 5-FU, or cisplatin.
• Pregnant or lactating female.
• Known hypersensitivity to fluoropyrimidines or cisplatin.

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

361 participants in 2 patient groups

S-1+Cisplatin

Experimental group

Description:

Participants received S-1 25 milligrams per meter square (mg/m\^2) orally twice daily (BID) every 12 hours from Day 1 through Day 21, 1 hour before or after meal with a glass of water; followed by a 7-day rest period from Day 22 to Day 28 in a 28-day cycle. Participants received a single dose of cisplatin 75 mg/m\^2 as a 1- to 3-hour intravenous (IV) infusion on Day 1 following the morning dose of S-1 for a maximum of 8 cycles (each cycle of 28 days). Participants received study medication until progression of disease (PD), adverse event (AE), withdrawal of consent, or other reason for discontinuation, whichever happened earlier.

Treatment:

Drug: S-1 (Tegafur+Gimeracil+Oteracil) /cisplatin (investigational arm)

5FU+Cisplatin

Active Comparator group

Description:

Participants received 5-Fluorouracil (5-FU) 800 mg/m\^2 per 24 hours as continuous IV infusion over 120 hours from Day 1 through Day 5 followed by a 16-day rest period on Days 6 through 21 in a 21-day cycle. Participants received a single dose of cisplatin 80 mg/m\^2 as a 1- to 3-hour IV infusion on Day 1 prior to the start of the 5-FU infusion on Day 1 for a maximum of 8 cycles (each cycle of 21 days). Participants received study medication until PD, AE, withdrawal of consent, or other reason for discontinuation, whichever happened earlier.

Treatment:

Drug: Fluorouracil/cisplatin (control arm)