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

Primary Purpose

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

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
S-1 (Tegafur+Gimeracil+Oteracil) /cisplatin (investigational arm)
Fluorouracil/cisplatin (control arm)
Sponsored by
Taiho Oncology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Diffuse Gastric Cancer Including Carcinoma of the Gastro-esophageal Junction focused on measuring Gastric Cancer , S-1, Phase 3

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

S-1+Cisplatin

5FU+Cisplatin

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Overall Survival (OS)
OS was defined as the time from randomization to the date of death for the ITT population. Participants who did not die were censored at the date last known to be alive. Analysis was performed by using Kaplan-Meier method.

Secondary Outcome Measures

Progression-free Survival (PFS)
PFS was defined as the time from date of randomization until date of radiological disease progression or death due to any cause. Disease Progression was defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, where any of the 3 criteria have been met: 1) at least 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum on study, including the baseline sum, 2) Progression in no-target lesion(s), 3) appearance of new lesion(s) Participants who were alive with no PD were censored at the date of the last tumor assessment. Participants who received new anticancer therapy before disease progression were censored at the date of the last evaluable tumor assessment before new anticancer therapy was initiated. Analysis was performed by using Kaplan-Meier method.
Time to Treatment Failure (TTF)
TTF was defined as the time from date of randomization until date of PD (clinical or radiologic), or permanent discontinuation of study treatment (S-1 or 5-FU), or death due to any cause. Participates who were still on study treatment at the time of the analysis were censored at the last date the participants was known to be on treatment.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAE)
AE was defined as any untoward medical condition that occurs in a participants while participating in a clinical study and does not necessarily had to have a causal relationship with the use of the study medication. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (from first dose of study medication up to 30 days of last study medication [maximum duration: 35.7 months]).
Number of Participants With TEAEs With Severity Greater Than or Equal to (>=) Grade 3
An AE was any untoward medical condition that occurred in a participants while participating in a clinical study and does not necessarily had to have a causal relationship with the use of the study medication. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (from first dose of study medication up to 30 days of last study medication [maximum duration: 35.7 months]).
Overall Response Rate (ORR): Percentage of Participants With Overall Response
ORR was defined as the percentage of participants with objective evidence of complete response (CR) or partial response (PR) based on the Investigator review of the images and application of Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as the disappearance of all target or non-target lesions. Any pathological lymph nodes for target lesions or all lymph nodes for non-target lesions were non-pathological morphologically that was reduced in size in short axis to less than (<) 10 millimeter (mm). PR was defined as target lesions with at least 30% decrease in the sum of diameters, taking baseline sum diameters as reference.
Duration of Response (DR)
Duration of response was defined as the time (in months) from date of first confirmed response (CR or PR) to date of first progressive disease (PD) or death. Per the RECIST criteria, definitions were as follows: CR was defined as the disappearance of all target or non-target lesions. Any pathological lymph nodes for target lesions or all lymph nodes for non-target lesions were non-pathological morphologically that was reduced in size in short axis to <10 mm. Analysis was performed by using Kaplan-Meier method.
Time to Tumor Response (TTR)
TTR was defined as the time (in months) from the date of randomization to the date of first observation of response (PR or CR) (whichever status was recorded first). TTR was assessed based on investigator assessment utilizing RECIST 1.1. CR was defined as the disappearance of all target or non-target lesions. Any pathological lymph nodes for target lesions or all lymph nodes for non-target lesions were non-pathological morphologically that was reduced in size in short axis to <10 mm. PR was defined as target lesions with at least 30% decrease in the sum of diameters, taking baseline sum diameters as reference. Analysis was performed by using Kaplan-Meier method.

Full Information

First Posted
January 26, 2011
Last Updated
April 22, 2022
Sponsor
Taiho Oncology, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01285557
Brief Title
Diffuse Gastric and Esophagogastric Junction Cancer S-1 Trial
Acronym
DIGEST
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
Due to significant changes in investigational and clinical practice landscape of frontline advanced gastric cancer, which challenged viability of trial and increased use of modified chemotherapeutic triplets led to slow participant accrual in study.
Study Start Date
April 14, 2011 (Actual)
Primary Completion Date
August 15, 2014 (Actual)
Study Completion Date
August 15, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiho Oncology, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Diffuse Gastric Cancer Including Carcinoma of the Gastro-esophageal Junction
Keywords
Gastric Cancer , S-1, Phase 3

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
361 (Actual)

8. Arms, Groups, and Interventions

Arm Title
S-1+Cisplatin
Arm Type
Experimental
Arm Description
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.
Arm Title
5FU+Cisplatin
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
S-1 (Tegafur+Gimeracil+Oteracil) /cisplatin (investigational arm)
Other Intervention Name(s)
TS-1, Tegafur+Gimeracil+Oteracil
Intervention Description
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
Intervention Name(s)
Fluorouracil/cisplatin (control arm)
Other Intervention Name(s)
TS-1, Tegafur+Gimeracil+Oteracil
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS was defined as the time from randomization to the date of death for the ITT population. Participants who did not die were censored at the date last known to be alive. Analysis was performed by using Kaplan-Meier method.
Time Frame
From the date of randomization until disease progression or death, cut-off date: 15 August 2014 (approximately 40 months)
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
PFS was defined as the time from date of randomization until date of radiological disease progression or death due to any cause. Disease Progression was defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, where any of the 3 criteria have been met: 1) at least 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum on study, including the baseline sum, 2) Progression in no-target lesion(s), 3) appearance of new lesion(s) Participants who were alive with no PD were censored at the date of the last tumor assessment. Participants who received new anticancer therapy before disease progression were censored at the date of the last evaluable tumor assessment before new anticancer therapy was initiated. Analysis was performed by using Kaplan-Meier method.
Time Frame
From date of randomization until disease progression or death, cut-off date: 07 March 2014 (approximately 34.7 months)
Title
Time to Treatment Failure (TTF)
Description
TTF was defined as the time from date of randomization until date of PD (clinical or radiologic), or permanent discontinuation of study treatment (S-1 or 5-FU), or death due to any cause. Participates who were still on study treatment at the time of the analysis were censored at the last date the participants was known to be on treatment.
Time Frame
From date of randomization until disease progression, cut-off date: 07 March 2014 (approximately 34.7 months)
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAE)
Description
AE was defined as any untoward medical condition that occurs in a participants while participating in a clinical study and does not necessarily had to have a causal relationship with the use of the study medication. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (from first dose of study medication up to 30 days of last study medication [maximum duration: 35.7 months]).
Time Frame
From first dose of study medication up to 30 days of last study medication (maximum duration: 35.7 months)
Title
Number of Participants With TEAEs With Severity Greater Than or Equal to (>=) Grade 3
Description
An AE was any untoward medical condition that occurred in a participants while participating in a clinical study and does not necessarily had to have a causal relationship with the use of the study medication. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (from first dose of study medication up to 30 days of last study medication [maximum duration: 35.7 months]).
Time Frame
From first dose of study medication up to 30 days of last study medication (maximum duration: 35.7 months)
Title
Overall Response Rate (ORR): Percentage of Participants With Overall Response
Description
ORR was defined as the percentage of participants with objective evidence of complete response (CR) or partial response (PR) based on the Investigator review of the images and application of Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as the disappearance of all target or non-target lesions. Any pathological lymph nodes for target lesions or all lymph nodes for non-target lesions were non-pathological morphologically that was reduced in size in short axis to less than (<) 10 millimeter (mm). PR was defined as target lesions with at least 30% decrease in the sum of diameters, taking baseline sum diameters as reference.
Time Frame
From date of first study medication until cut-off date: 07 March 2014 (approximately 34.7 months)
Title
Duration of Response (DR)
Description
Duration of response was defined as the time (in months) from date of first confirmed response (CR or PR) to date of first progressive disease (PD) or death. Per the RECIST criteria, definitions were as follows: CR was defined as the disappearance of all target or non-target lesions. Any pathological lymph nodes for target lesions or all lymph nodes for non-target lesions were non-pathological morphologically that was reduced in size in short axis to <10 mm. Analysis was performed by using Kaplan-Meier method.
Time Frame
From date of first study medication until cut-off date: 07 March 2014 (approximately 34.7 months)
Title
Time to Tumor Response (TTR)
Description
TTR was defined as the time (in months) from the date of randomization to the date of first observation of response (PR or CR) (whichever status was recorded first). TTR was assessed based on investigator assessment utilizing RECIST 1.1. CR was defined as the disappearance of all target or non-target lesions. Any pathological lymph nodes for target lesions or all lymph nodes for non-target lesions were non-pathological morphologically that was reduced in size in short axis to <10 mm. PR was defined as target lesions with at least 30% decrease in the sum of diameters, taking baseline sum diameters as reference. Analysis was performed by using Kaplan-Meier method.
Time Frame
From date of first study medication until cut-off date: 07 March 2014 (approximately 34.7 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taiho Central
Organizational Affiliation
Taiho Oncology, Inc. USA
Official's Role
Study Director
Facility Information:
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000KZE
Country
Argentina
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
1264
Country
Argentina
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
City
Gent
ZIP/Postal Code
9000
Country
Belgium
City
Salvador
State/Province
BA
ZIP/Postal Code
41820-021
Country
Brazil
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
City
Barretos
State/Province
SP
ZIP/Postal Code
14784-400
Country
Brazil
City
Ribeirão Preto
State/Province
SP
ZIP/Postal Code
14015-130
Country
Brazil
City
São Paulo
State/Province
SP
ZIP/Postal Code
01246-000
Country
Brazil
City
São Paulo
State/Province
SP
ZIP/Postal Code
01406-100
Country
Brazil
City
Belo Horizonte
ZIP/Postal Code
31110-580
Country
Brazil
City
Fortaleza
ZIP/Postal Code
60160-230
Country
Brazil
City
Ijuí
ZIP/Postal Code
98700-000
Country
Brazil
City
Porto Alegre
ZIP/Postal Code
90050-170
Country
Brazil
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
City
Tallinn
ZIP/Postal Code
11312
Country
Estonia
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
City
Essen
ZIP/Postal Code
45147
Country
Germany
City
Budapest
ZIP/Postal Code
1032
Country
Hungary
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
City
Győor
ZIP/Postal Code
9024
Country
Hungary
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
City
Pécs
ZIP/Postal Code
7624
Country
Hungary
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
City
Székesfehérvár
ZIP/Postal Code
8000
Country
Hungary
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
City
Ancona
ZIP/Postal Code
60020
Country
Italy
City
Candiolo
ZIP/Postal Code
10060
Country
Italy
City
Milano
ZIP/Postal Code
20141
Country
Italy
City
Modena
ZIP/Postal Code
41100
Country
Italy
City
Potenza
ZIP/Postal Code
85100
Country
Italy
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
City
Rimini
ZIP/Postal Code
47900
Country
Italy
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
City
Mexico City
ZIP/Postal Code
14080
Country
Mexico
City
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
City
Szczecin
ZIP/Postal Code
71-730
Country
Poland
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
City
Aveiro
ZIP/Postal Code
3814-501
Country
Portugal
City
Coimbra
ZIP/Postal Code
3000-226
Country
Portugal
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
City
Baia Mare
ZIP/Postal Code
430031
Country
Romania
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
City
Craiova
ZIP/Postal Code
200385
Country
Romania
City
Iasi
ZIP/Postal Code
700106
Country
Romania
City
Barnaul
ZIP/Postal Code
656049
Country
Russian Federation
City
Krasnodar
ZIP/Postal Code
350040
Country
Russian Federation
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
City
Pyatigorsk
ZIP/Postal Code
357502
Country
Russian Federation
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
City
Saint Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
City
Saint-Petersburg
ZIP/Postal Code
194214
Country
Russian Federation
City
Groenkloof Pretoria
State/Province
Gauteng
ZIP/Postal Code
0181
Country
South Africa
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0002
Country
South Africa
City
Durban
State/Province
KZN
ZIP/Postal Code
4091
Country
South Africa
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7500
Country
South Africa
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
City
Madrid
ZIP/Postal Code
28007
Country
Spain
City
Madrid
ZIP/Postal Code
28033
Country
Spain
City
Madrid
ZIP/Postal Code
28034
Country
Spain
City
Madrid
ZIP/Postal Code
28046
Country
Spain
City
Madrid
ZIP/Postal Code
28050
Country
Spain
City
Cherkassy
ZIP/Postal Code
18009
Country
Ukraine
City
Chernivtsiy
ZIP/Postal Code
58013
Country
Ukraine
City
Dnepropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
City
Donetsk
ZIP/Postal Code
83092
Country
Ukraine
City
Kharkiv
ZIP/Postal Code
61070
Country
Ukraine
City
Kyiv
ZIP/Postal Code
3115
Country
Ukraine
City
Lutsk
ZIP/Postal Code
43018
Country
Ukraine
City
Lviv
ZIP/Postal Code
79031
Country
Ukraine
City
Sumy
ZIP/Postal Code
40005
Country
Ukraine
City
Uzhgorod
ZIP/Postal Code
88000
Country
Ukraine
City
Zaporizzhya
ZIP/Postal Code
69040
Country
Ukraine
City
Rhyl
State/Province
Wales
ZIP/Postal Code
LL18 5UJ
Country
United Kingdom
City
London
ZIP/Postal Code
W12 0NN
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28911091
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.
Results Reference
derived

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Diffuse Gastric and Esophagogastric Junction Cancer S-1 Trial

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