Diffuse Gastric and Esophagogastric Junction Cancer S-1 Trial

NCT ID: NCT01285557

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 361 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-14
• Study Completion Date: 2014-08-15

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 gastro-esophageal junction cancer previously untreated with chemotherapy.

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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

S-1+Cisplatin

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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.

5FU+Cisplatin

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.

Group Type: ACTIVE_COMPARATOR

Fluorouracil/cisplatin (control arm)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

TS-1, Tegafur+Gimeracil+Oteracil; TS-1, Tegafur+Gimeracil+Oteracil

Eligibility 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.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taiho Oncology, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Taiho Central

Role: STUDY_DIRECTOR

Taiho Oncology, Inc. USA

Locations

Alexandria, Louisiana, United States

Albuquerque, New Mexico, United States

Dallas, Texas, United States

Houston, Texas, United States

Rosario, Santa Fe Province, Argentina

Buenos Aires, , Argentina

Brussels, , Belgium

Edegem, , Belgium

Ghent, , Belgium

Salvador, Estado de Bahia, Brazil

Porto Alegre, Rio Grande do Sul, Brazil

Barretos, São Paulo, Brazil

Ribeirão Preto, São Paulo, Brazil

São Paulo, São Paulo, Brazil

São Paulo, São Paulo, Brazil

Belo Horizonte, , Brazil

Fortaleza, , Brazil

Ijuí, , Brazil

Porto Alegre, , Brazil

Pleven, , Bulgaria

Vratsa, , Bulgaria

Osijek, , Croatia

Zagreb, , Croatia

Tallinn, , Estonia

Tallinn, , Estonia

Essen, , Germany

Budapest, , Hungary

Budapest, , Hungary

Győor, , Hungary

Nyíregyháza, , Hungary

Pécs, , Hungary

Szeged, , Hungary

Székesfehérvár, , Hungary

Tel Aviv, , Israel

Ancona, , Italy

Candiolo, , Italy

Milan, , Italy

Modena, , Italy

Potenza, , Italy

Reggio Emilia, , Italy

Rimini, , Italy

Chihuahua City, , Mexico

Mexico City, , Mexico

Oaxaca City, , Mexico

Szczecin, , Poland

Warsaw, , Poland

Aveiro, , Portugal

Coimbra, , Portugal

Lisbon, , Portugal

Porto, , Portugal

Baia Mare, , Romania

Cluj-Napoca, , Romania

Craiova, , Romania

Iași, , Romania

Barnaul, , Russia

Krasnodar, , Russia

Moscow, , Russia

Pyatigorsk, , Russia

Saint Petersburg, , Russia

Saint Petersburg, , Russia

Saint Petersburg, , Russia

Groenkloof Pretoria, Gauteng, South Africa

Pretoria, Gauteng, South Africa

Durban, KwaZulu-Natal, South Africa

Cape Town, Western Cape, South Africa

Sabadell, Barcelona, Spain

Barcelona, , Spain

Barcelona, , Spain

Barcelona, , Spain

Madrid, , Spain

Madrid, , Spain

Madrid, , Spain

Madrid, , Spain

Madrid, , Spain

Cherkassy, , Ukraine

Chernivtsiy, , Ukraine

Dnipro, , Ukraine

Donetsk, , Ukraine

Kharkiv, , Ukraine

Kyiv, , Ukraine

Lutsk, , Ukraine

Lviv, , Ukraine

Sumy, , Ukraine

Uzhhorod, , Ukraine

Zaporizzhya, , Ukraine

Rhyl, Wales, United Kingdom

London, , United Kingdom

Countries

United States; Argentina; Belgium; Brazil; Bulgaria; Croatia; Estonia; Germany; Hungary; Israel; Italy; Mexico; Poland; Portugal; Romania; Russia; South Africa; Spain; Ukraine; United Kingdom

References

Ajani JA, Abramov M, Bondarenko I, Shparyk Y, Gorbunova V, Hontsa A, Otchenash N, Alsina M, Lazarev S, Feliu J, Elme A, Esko V, Abdalla K, Verma U, Benedetti F, Aoyama T, Mizuguchi H, Makris L, Rosati G; DIGEST Study Group. A phase III trial comparing oral S-1/cisplatin and intravenous 5-fluorouracil/cisplatin in patients with untreated diffuse gastric cancer. Ann Oncol. 2017 Sep 1;28(9):2142-2148. doi: 10.1093/annonc/mdx275.

Reference Type: DERIVED

PMID: 28911091 (View on PubMed)

Other Identifiers

TPU-S1303

Identifier Type: -

Identifier Source: org_study_id