Trial · NCT01285557
Diffuse Gastric and Esophagogastric Junction Cancer S-1 Trial
NCT01285557, Phase 3, Terminated, Taiho Oncology, Inc.; results first posted 2022-05-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Diffuse Gastric and Esophagogastric Junction Cancer S-1 Trial. Trials, record NCT01285557. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01285557
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Diffuse Gastric and Esophagogastric Junction Cancer S-1 Trial
- NCT number
- NCT01285557
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 361 participants, actual
- Lead sponsor
- Taiho Oncology, Inc.
- Conditions
- Metastatic Diffuse Gastric Cancer Including Carcinoma of the Gastro-esophageal Junction
- Interventions
- S-1 (Tegafur+Gimeracil+Oteracil) /cisplatin (investigational arm), Fluorouracil/cisplatin (control arm)
- First posted
- 2011-01-28
- Last updated
- 2024-09-19
- Results first posted
- 2022-05-17
- Limitations and caveats
Enrollment closure and study termination was 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 the study. The decision to halt further accrual was not based on any safety or study quality concerns.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | From the date of randomization until disease progression or death, cut-off date: 15 August 2014 (approximately 40 months) | 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 | Progression-free Survival (PFS) | From date of randomization until disease progression or death, cut-off date: 07 March 2014 (approximately 34.7 months) | 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. |
| Secondary | Time to Treatment Failure (TTF) | From date of randomization until disease progression, cut-off date: 07 March 2014 (approximately 34.7 months) | 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. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAE) | From first dose of study medication up to 30 days of last study medication (maximum duration: 35.7 months) | 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 \[maximum duration: 35.7 months\]). |
| Secondary | Number of Participants With TEAEs With Severity Greater Than or Equal to (>=) Grade 3 | From first dose of study medication up to 30 days of last study medication (maximum duration: 35.7 months) | 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 \[maximum duration: 35.7 months\]). |
| Secondary | Overall Response Rate (ORR): Percentage of Participants With Overall Response | From date of first study medication until cut-off date: 07 March 2014 (approximately 34.7 months) | 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. |
| Secondary | Duration of Response (DR) | From date of first study medication until cut-off date: 07 March 2014 (approximately 34.7 months) | 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. |
| Secondary | Time to Tumor Response (TTR) | From date of first study medication until cut-off date: 07 March 2014 (approximately 34.7 months) | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | From the date of randomization until disease progression or death, cut-off date: 15 August 2014 (approximately 40 months) | Analysis was performed on the ITT population that included all randomized participants. | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | From date of randomization until disease progression or death, cut-off date: 07 March 2014 (approximately 34.7 months) | Analysis was performed on the ITT population. | months | MEDIAN |
| SECONDARY | Time to Treatment Failure (TTF) | From date of randomization until disease progression, cut-off date: 07 March 2014 (approximately 34.7 months) | Analysis was performed on the ITT population. | months | MEDIAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAE) | From first dose of study medication up to 30 days of last study medication (maximum duration: 35.7 months) | Analysis was performed on the as treated (AT) population that included all participants who initiated treatment with either of the 2 regimens with treatment assignment designated according to actual treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With TEAEs With Severity Greater Than or Equal to (>=) Grade 3 | From first dose of study medication up to 30 days of last study medication (maximum duration: 35.7 months) | Analysis was performed on the as treated (AT) population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Response Rate (ORR): Percentage of Participants With Overall Response | From date of first study medication until cut-off date: 07 March 2014 (approximately 34.7 months) | Analysis was performed on the ITT population. Here, 'overall number of participants analyzed' signifies participants with available data for the outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DR) | From date of first study medication until cut-off date: 07 March 2014 (approximately 34.7 months) | Analysis was performed on the ITT population. Here, 'overall number of participants analyzed' signifies participants with available data for the outcome measure. | months | MEDIAN |
| SECONDARY | Time to Tumor Response (TTR) | From date of first study medication until cut-off date: 07 March 2014 (approximately 34.7 months) | Analysis was performed on the ITT population. Here, 'overall number of participants analyzed' signifies participants with available data for the outcome measure. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | S-1+Cisplatin | 7.5 | 95% Confidence Interval 6.7 to 9.3 | months | |
| Overall Survival (OS) | 5FU+Cisplatin | 6.6 | 95% Confidence Interval 5.7 to 8.1 | months | |
| Progression-free Survival (PFS) | S-1+Cisplatin | 4.4 | 95% Confidence Interval 3.8 to 5.6 | months | |
| Progression-free Survival (PFS) | 5FU+Cisplatin | 3.9 | 95% Confidence Interval 3.6 to 5.2 | months | |
| Time to Treatment Failure (TTF) | S-1+Cisplatin | 4.2 | 95% Confidence Interval 3.8 to 4.9 | months | |
| Time to Treatment Failure (TTF) | 5FU+Cisplatin | 3.8 | 95% Confidence Interval 3.4 to 4.3 | months | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAE) | S-1+Cisplatin | TEAE | 214 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAE) | 5FU+Cisplatin | TEAE | 111 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAE) | S-1+Cisplatin | TESAE | 63 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAE) | 5FU+Cisplatin | TESAE | 31 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | S-1+Cisplatin | 239 | |
| Overall Study | STARTED | 5FU+Cisplatin | 122 | |
| Overall Study | Treated | S-1+Cisplatin | 238 | |
| Overall Study | Treated | 5FU+Cisplatin | 121 | |
| Overall Study | As Treated (AT) Population | S-1+Cisplatin | 230 | |
| Overall Study | As Treated (AT) Population | 5FU+Cisplatin | 118 | |
| Overall Study | COMPLETED | S-1+Cisplatin | 0 | |
| Overall Study | COMPLETED | 5FU+Cisplatin | 0 | |
| Overall Study | NOT COMPLETED | S-1+Cisplatin | 239 | |
| Overall Study | NOT COMPLETED | 5FU+Cisplatin | 122 |
Source ClinicalTrials.gov
Adverse events248
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | S-1+Cisplatin | 97 | 230 | 160 |
| other | Anaemia | Blood and lymphatic system disorders | 5FU+Cisplatin | 49 | 118 | 86 |
| other | Granulocytopenia | Blood and lymphatic system disorders | S-1+Cisplatin | 13 | 230 | 59 |
| other | Granulocytopenia | Blood and lymphatic system disorders | 5FU+Cisplatin | 5 | 118 | 8 |
| other | Leukopenia | Blood and lymphatic system disorders | S-1+Cisplatin | 31 | 230 | 80 |
| other | Leukopenia | Blood and lymphatic system disorders | 5FU+Cisplatin | 12 | 118 | 23 |
| other | Neutropenia | Blood and lymphatic system disorders | S-1+Cisplatin | 68 | 230 | 161 |
| other | Neutropenia | Blood and lymphatic system disorders | 5FU+Cisplatin | 43 | 118 | 92 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | S-1+Cisplatin | 37 | 230 | 74 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | 5FU+Cisplatin | 10 | 118 | 12 |
1 to 10 of 248Source ClinicalTrials.gov
See all 248 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | S-1+Cisplatin | 173 | 239 |
| Total, all-cause mortality | 5FU+Cisplatin | 90 | 122 |
| Total, other adverse events | S-1+Cisplatin | 210 | 230 |
| Total, other adverse events | 5FU+Cisplatin | 110 | 118 |
| Total, serious adverse events | S-1+Cisplatin | 63 | 230 |
| Total, serious adverse events | 5FU+Cisplatin | 31 | 118 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28911091 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| S-1+Cisplatin vs 5FU+Cisplatin: Number of Participants With TEAEs With Severity Greater Than or Equal to (>=) Grade 3 | Trial comparisons |
| S-1+Cisplatin vs 5FU+Cisplatin: deaths from any cause | Trial comparisons |
| S-1+Cisplatin vs 5FU+Cisplatin: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01285557
GET https://conductscience.org/api/trials/v1/NCT01285557/events?page=2