Clinical trial NCT01285557: Diffuse Gastric and Esophagogastric Junction Cancer S-1 Trial
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Metastatic Diffuse Gastric Cancer Including Carcinoma of the Gastro-esophageal Junction
Keywords: Gastric Cancer , S-1, Phase 3
Lead sponsor: Taiho Oncology, Inc.
Sponsor class: INDUSTRY
First posted: 2011-01-28
Enrollment: 361
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: From the date of randomization until disease progression or death, cut-off date: 15 August 2014 (approximately 40 months)
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: From date of randomization until disease progression or death, cut-off date: 07 March 2014 (approximately 34.7 months)
measure: Time to Treatment Failure (TTF)
timeFrame: From date of randomization until disease progression, cut-off date: 07 March 2014 (approximately 34.7 months)
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAE)
timeFrame: From first dose of study medication up to 30 days of last study medication (maximum duration: 35.7 months)
measure: Number of Participants With TEAEs With Severity Greater Than or Equal to (>=) Grade 3
timeFrame: From first dose of study medication up to 30 days of last study medication (maximum duration: 35.7 months)
measure: Overall Response Rate (ORR): Percentage of Participants With Overall Response
timeFrame: From date of first study medication until cut-off date: 07 March 2014 (approximately 34.7 months)
measure: Duration of Response (DR)
timeFrame: From date of first study medication until cut-off date: 07 March 2014 (approximately 34.7 months)
measure: Time to Tumor Response (TTR)
timeFrame: From date of first study medication until cut-off date: 07 March 2014 (approximately 34.7 months)
Other outcomes:
Locations:
city: Alexandria
country: United States
state: Louisiana
city: Albuquerque
country: United States
state: New Mexico
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Rosario
country: Argentina
state: Santa Fe
city: Ciudad Autonoma de Buenos Aires
country: Argentina
city: Bruxelles
country: Belgium
city: Edegem
country: Belgium
city: Gent
country: Belgium
city: Salvador
country: Brazil
state: BA
city: Porto Alegre
country: Brazil
state: RS
city: Barretos
country: Brazil
state: SP
city: Ribeirão Preto
country: Brazil
state: SP
city: São Paulo
country: Brazil
state: SP
city: São Paulo
country: Brazil
state: SP
city: Belo Horizonte
country: Brazil
city: Fortaleza
country: Brazil
city: Ijuí
country: Brazil
city: Porto Alegre
country: Brazil
city: Pleven
country: Bulgaria
city: Vratsa
country: Bulgaria
city: Osijek
country: Croatia
city: Zagreb
country: Croatia
city: Tallinn
country: Estonia
city: Tallinn
country: Estonia
city: Essen
country: Germany
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Győor
country: Hungary
city: Nyíregyháza
country: Hungary
city: Pécs
country: Hungary
city: Szeged
country: Hungary
city: Székesfehérvár
country: Hungary
city: Tel Aviv
country: Israel
city: Ancona
country: Italy
city: Candiolo
country: Italy
city: Milano
country: Italy
city: Modena
country: Italy
city: Potenza
country: Italy
city: Reggio Emilia
country: Italy
city: Rimini
country: Italy
city: Chihuahua
country: Mexico
city: Mexico City
country: Mexico
city: Oaxaca
country: Mexico
city: Szczecin
country: Poland
city: Warszawa
country: Poland
city: Aveiro
country: Portugal
city: Coimbra
country: Portugal
city: Lisboa
country: Portugal
city: Porto
country: Portugal
city: Baia Mare
country: Romania
city: Cluj-Napoca
country: Romania
city: Craiova
country: Romania
city: Iasi
country: Romania
city: Barnaul
country: Russian Federation
city: Krasnodar
country: Russian Federation
city: Moscow
country: Russian Federation
city: Pyatigorsk
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Groenkloof Pretoria
country: South Africa
state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Durban
country: South Africa
state: KZN
city: Cape Town
country: South Africa
state: Western Cape
city: Sabadell
country: Spain
state: Barcelona
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Cherkassy
country: Ukraine
city: Chernivtsiy
country: Ukraine
city: Dnepropetrovsk
country: Ukraine
city: Donetsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Lutsk
country: Ukraine
city: Lviv
country: Ukraine
city: Sumy
country: Ukraine
city: Uzhgorod
country: Ukraine
city: Zaporizzhya
country: Ukraine
city: Rhyl
country: United Kingdom
state: Wales
city: London
country: United Kingdom
Study officials:
affiliation: Taiho Oncology, Inc. USA
name: Taiho Central
role: STUDY_DIRECTOR
References:
citation: 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.