Text Size

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

This study is currently recruiting participants.
Verified April 2013 by Taiho Pharma USA, Inc.
Sponsor:
Information provided by (Responsible Party):
Taiho Pharma USA, Inc.
ClinicalTrials.gov Identifier:
NCT01285557
First received: January 26, 2011
Last updated: April 8, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Taiho Pharma USA, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: Throughout ] [ Designated as safety issue: No ]
  • Time to treatment failure (TTF) [ Time Frame: Throughout ] [ Designated as safety issue: No ]
  • Antitumor activity: Overall Response Rate (ORR), duration of response (DR), time to tumor response (TTR); [ Time Frame: Throughout ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: Treatment period ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: February 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01285557

Contacts
Contact: CenterWatch 1-888-292-2990 (Menu Option 0) gastricstudy@centerwatch.com

  Show 111 Study Locations
Sponsors and Collaborators
Taiho Pharma USA, Inc.
Investigators
Principal Investigator: Jaffer Ajani, MD M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: Taiho Pharma USA, Inc.
ClinicalTrials.gov Identifier: NCT01285557     History of Changes
Other Study ID Numbers: TPU-S1303
Study First Received: January 26, 2011
Last Updated: April 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Taiho Pharma USA, Inc.:
Gastric Cancer , S-1, Phase 3

Additional relevant MeSH terms:
Carcinoma
Esophageal Diseases
Stomach Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Stomach Diseases
Cisplatin
 Fluorouracil
Tegafur
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on May 23, 2013