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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01285557
Recruitment Status : Unknown
Verified October 2016 by Taiho Oncology, Inc..
Recruitment status was:  Active, not recruiting
First Posted : January 28, 2011
Last Update Posted : October 21, 2016
Information provided by (Responsible Party):
Taiho Oncology, Inc.

Brief Summary:
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 esophagogastric junction cancer previously untreated with chemotherapy.

Condition or disease Intervention/treatment Phase
Metastatic Diffuse Gastric Cancer Including Carcinoma of the Gastro-esophageal Junction Drug: S-1 (Tegafur/Gimeracil/Oteracil) /cisplatin (investigational arm) Drug: Fluorouracil/cisplatin (control arm) Phase 3

Detailed 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : February 2011
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: S-1/cisplatin Drug: S-1 (Tegafur/Gimeracil/Oteracil) /cisplatin (investigational arm)
25 mg/m² body surface area (BSA) orally 2 times daily from Days 1 through 21 followed by a 7 day rest period, plus cisplatin 75 mg/m2 BSA on Day 1 each 28 day cycle Number of Cycles: until progression or unacceptable toxicity develops. Treatment with cisplatin is limited to a maximum of 8 cycles.
Other Name: TS-1, Tegafur/Gimeracil/Oteracil

Active Comparator: 5-FU/cisplatin Drug: Fluorouracil/cisplatin (control arm)

5-FU: 800 mg/m2 BSA/24 hours by continuous intravenous infusion (CIV) from Days 1 through 5 plus cisplatin 80 mg/m2 BSA on Day 1 each 21 day cycle.

Number of Cycles: until progression or unacceptable toxicity develops. Treatment with cisplatin is limited to a maximum of 8 cycles.

Other Name: TS-1, Tegafur/Gimeracil/Oteracil

Primary Outcome Measures :
  1. Outcome Measure: Overall survival (OS) [ Time Frame: 12 months after the last patient is randomized or the target number of events is reached, whichever is later ]

Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: Throughout ]
  2. Time to treatment failure (TTF) [ Time Frame: Throughout ]
  3. Antitumor activity: Overall Response Rate (ORR), duration of response (DR), time to tumor response (TTR); [ Time Frame: Throughout ]
  4. Safety and tolerability [ Time Frame: Treatment period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  • ECOG 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 ICF
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01285557

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Sponsors and Collaborators
Taiho Oncology, Inc.
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Principal Investigator: Jaffer Ajani, MD M.D. Anderson Cancer Center

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Taiho Oncology, Inc. Identifier: NCT01285557     History of Changes
Other Study ID Numbers: TPU-S1303
First Posted: January 28, 2011    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2016
Keywords provided by Taiho Oncology, Inc.:
Gastric Cancer , S-1, Phase 3
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs