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:
Taiho Pharma USA, Inc.
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
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
Hide Study Locations
Contacts
| Contact: CenterWatch | 1-888-292-2990 (Menu Option 0) | gastricstudy@centerwatch.com |
Hide Study LocationsLocations
| United States, California | |
| Recruiting | |
| Beverly Hills, California, United States, 90211 | |
| United States, Louisiana | |
| Recruiting | |
| Alexandria, Louisiana, United States, 71301 | |
| United States, New Mexico | |
| Recruiting | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, Pennsylvania | |
| Recruiting | |
| Hershey, Pennsylvania, United States, 17033 | |
| United States, South Carolina | |
| Active, not recruiting | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Texas | |
| Recruiting | |
| Dallas, Texas, United States, 75390 | |
| Recruiting | |
| Houston, Texas, United States, 77030 | |
| Argentina | |
| Recruiting | |
| Rosario, Santa Fe, Argentina, S2000KZE | |
| Recruiting | |
| Ciudad Autonoma de Buenos Aires, Argentina, 1264 | |
| Belgium | |
| Recruiting | |
| Bruxelles, Belgium, 1200 | |
| Recruiting | |
| Edegem, Belgium, 2650 | |
| Active, not recruiting | |
| Gent, Belgium, 9000 | |
| Recruiting | |
| Liège, Belgium, 4000 | |
| Brazil | |
| Recruiting | |
| Salvador, BA, Brazil, 41820-021 | |
| Recruiting | |
| Porto Alegre, RS, Brazil, 90610-000 | |
| Recruiting | |
| Barretos, SP, Brazil, 14784-400 | |
| Recruiting | |
| Ribeirão Preto, SP, Brazil, 14015-130 | |
| Recruiting | |
| São Paulo, SP, Brazil, 01406-100 | |
| Recruiting | |
| São Paulo, SP, Brazil, 01246-000 | |
| Recruiting | |
| Belo Horizonte, XX, Brazil, 31110-580 | |
| Recruiting | |
| Fortaleza, XX, Brazil, 60160-230 | |
| Recruiting | |
| Ijuí, XX, Brazil, 98700-000 | |
| Bulgaria | |
| Active, not recruiting | |
| Gabrovo, Bulgaria, 5300 | |
| Recruiting | |
| Pleven, Bulgaria, 5800 | |
| Active, not recruiting | |
| Varna, Bulgaria, 9000 | |
| Recruiting | |
| Vratsa, Bulgaria, 3000 | |
| Colombia | |
| Active, not recruiting | |
| Teusaquillo, Bogotá, Colombia, 111311 | |
| Croatia | |
| Recruiting | |
| Osijek, Croatia, 31000 | |
| Recruiting | |
| Zagreb, Croatia, 10000 | |
| Active, not recruiting | |
| Zagreb, Croatia, 10000 | |
| Estonia | |
| Recruiting | |
| Tallinn, Estonia, 11312 | |
| Recruiting | |
| Tallinn, Estonia, 13419 | |
| Germany | |
| Recruiting | |
| Herne, North Rhine-Westphalia, Germany, 44625 | |
| Recruiting | |
| Trier, Rheinland-Pfalz, Germany, 54290 | |
| Recruiting | |
| Aachen, Germany, 52074 | |
| Recruiting | |
| Essen, Germany, 45147 | |
| Active, not recruiting | |
| Leverkusen, Germany, 51375 | |
| Recruiting | |
| Muenchen, Germany, 81925 | |
| Hungary | |
| Recruiting | |
| Budapest, Hungary, 1122 | |
| Recruiting | |
| Győor, Hungary, 9024 | |
| Recruiting | |
| Nyíregyháza, Hungary, 4400 | |
| Recruiting | |
| Pécs, Hungary, 7624 | |
| Recruiting | |
| Szeged, Hungary, 6720 | |
| Recruiting | |
| Székesfehérvár, Hungary, 8000 | |
| Israel | |
| Active, not recruiting | |
| Beer Sheva, Israel, 84101 | |
| Active, not recruiting | |
| Jerusalem, Israel, 91120 | |
| Active, not recruiting | |
| Kfar Saba, Israel, 44281 | |
| Active, not recruiting | |
| Ramat Gan, Israel, 52621 | |
| Recruiting | |
| Tel Aviv, Israel, 64239 | |
| Italy | |
| Recruiting | |
| Milano, Italy, 20141 | |
| Recruiting | |
| Milano, Italy, 20132 | |
| Recruiting | |
| Modena, Italy, 41100 | |
| Recruiting | |
| Potenza, Italy, 85100 | |
| Recruiting | |
| Reggio Emilia, Italy, 42100 | |
| Recruiting | |
| Rimini, Italy, 47900 | |
| Mexico | |
| Recruiting | |
| Mexico City, XX, Mexico, 14080 | |
| Recruiting | |
| Chihuahua, Mexico, 31000 | |
| Recruiting | |
| Oaxaca, Mexico, 68000 | |
| Poland | |
| Active, not recruiting | |
| Gdansk, Poland, 80-952 | |
| Active, not recruiting | |
| Lodz, Poland, 93-509 | |
| Recruiting | |
| Olsztyn, Poland, 10-228 | |
| Recruiting | |
| Szczecin, Poland, 71-730 | |
| Recruiting | |
| Warszawa, Poland, 02-781 | |
| Portugal | |
| Recruiting | |
| Lisboa, XX, Portugal, 1649-035 | |
| Recruiting | |
| Aveiro, Portugal, 3814-501 | |
| Recruiting | |
| Barreiro, Portugal, 2830-094 | |
| Recruiting | |
| Coimbra, Portugal, 3000-226 | |
| Recruiting | |
| Porto, Portugal, 4200-072 | |
| Romania | |
| Recruiting | |
| Baia Mare, Romania, 430031 | |
| Recruiting | |
| Cluj-Napoca, Romania, 400015 | |
| Recruiting | |
| Craiova, Romania, 200385 | |
| Active, not recruiting | |
| Craiova, Romania, 200385 | |
| Recruiting | |
| Iasi, Romania, 700106 | |
| Recruiting | |
| Onesti, Romania, 601048 | |
| Russian Federation | |
| Recruiting | |
| Saint-Petersburg, XX, Russian Federation, 194214 | |
| Recruiting | |
| Barnaul, Russian Federation, 656049 | |
| Recruiting | |
| Moscow, Russian Federation, 115478 | |
| Recruiting | |
| Saint Petersburg, Russian Federation, 197022 | |
| Recruiting | |
| Saint Petersburg, Russian Federation, 197758 | |
| South Africa | |
| Recruiting | |
| Port Elisabeth, Eastern Cape, South Africa, 6045 | |
| Recruiting | |
| Groenkloof Pretoria, Gauteng, South Africa, 0181 | |
| Recruiting | |
| Pretoria, Gauteng, South Africa, 0002 | |
| Recruiting | |
| Durban, KZN, South Africa, 4091 | |
| Recruiting | |
| Cape Town, WC, South Africa, 7700 | |
| Recruiting | |
| Cape Town, Western Cape, South Africa, 7500 | |
| Spain | |
| Recruiting | |
| Elche, Alicante, Spain, 03203 | |
| Recruiting | |
| Sabadell, Barcelona, Spain, 08208 | |
| Recruiting | |
| Barcelona, Spain, 08907 | |
| Recruiting | |
| Barcelona, Spain, 08035 | |
| Recruiting | |
| Barcelona, Spain, 08036 | |
| Recruiting | |
| Barcelona, Spain, 08906 | |
| Recruiting | |
| Madrid, Spain, 28034 | |
| Recruiting | |
| Madrid, Spain, 28033 | |
| Recruiting | |
| Madrid, Spain, 28050 | |
| Recruiting | |
| Madrid, Spain, 28046 | |
| Recruiting | |
| Madrid, Spain, 28007 | |
| Active, not recruiting | |
| Malaga, Spain, 29010 | |
| Recruiting | |
| Valencia, Spain, 46014 | |
| Ukraine | |
| Recruiting | |
| Cherkassy, Ukraine, 18009 | |
| Recruiting | |
| Chernivtsiy, Ukraine, 58013 | |
| Recruiting | |
| Dnepropetrovsk, Ukraine, 49102 | |
| Recruiting | |
| Donetsk, Ukraine, 83092 | |
| Recruiting | |
| Kharkiv, Ukraine, 61070 | |
| Recruiting | |
| Kyiv, Ukraine, 3115 | |
| Recruiting | |
| Lutsk, Ukraine, 43018 | |
| Recruiting | |
| Lviv, Ukraine, 79031 | |
| Recruiting | |
| Sumy, Ukraine, 40005 | |
| Recruiting | |
| Uzhgorod, Ukraine, 83092 | |
| Recruiting | |
| Zaporizzhya, Ukraine, 69040 | |
| United Kingdom | |
| Recruiting | |
| Rhyl, Wales, United Kingdom, LL18 5UJ | |
| Recruiting | |
| London, United Kingdom, W12 0NN | |
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 June 18, 2013