Trial · NCT00770874
Phase III Study of S-1 + Cisplatin vs Cisplatin in Cervical Cancer
NCT00770874, Phase 3, Completed, Taiho Pharmaceutical Co., Ltd.; results first posted 2019-06-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase III Study of S-1 + Cisplatin vs Cisplatin in Cervical Cancer. Trials, record NCT00770874. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00770874
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase III Study of S-1 + Cisplatin vs Cisplatin in Cervical Cancer
- NCT number
- NCT00770874
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 375 participants, actual
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.
- Conditions
- Cervical Cancer
- Interventions
- S-1 + Cisplatin (arm A), Cisplatin (arm B)
- First posted
- 2008-10-10
- Last updated
- 2019-06-21
- Results first posted
- 2019-06-21
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | From the date of randomization to death from any cause, assessed up to 296 events or the end of November 2015, whichever was earlier, each three months | |
| Secondary | Progression Free Survival, Safety | About Progression free survival, from the randomization to disease progression or death, whichever came first, assessed up to until primary outcome came each three months, and about safety, from the first treatment to 30 days after the last treatment | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | From the date of randomization to death from any cause, assessed up to 296 events or the end of November 2015, whichever was earlier, each three months | Full analysis set | months | MEDIAN |
| SECONDARY | Progression Free Survival, Safety | About Progression free survival, from the randomization to disease progression or death, whichever came first, assessed up to until primary outcome came each three months, and about safety, from the first treatment to 30 days after the last treatment | Full analysis set | months | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | S-1 + Cisplatin (Arm A) | 21.9 | 95% Confidence Interval 18.6 to 25.8 | months | |
| Overall Survival | Cisplatin (Arm B) | 19.5 | 95% Confidence Interval 17.0 to 24.3 | months | |
| Progression Free Survival, Safety | S-1 + Cisplatin (Arm A) | 7.3 | 95% Confidence Interval 6.7 to 8.1 | months | |
| Progression Free Survival, Safety | Cisplatin (Arm B) | 4.9 | 95% Confidence Interval 4.4 to 5.7 | months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | S-1 + Cisplatin (Arm A) | 188 | |
| Overall Study | STARTED | Cisplatin (Arm B) | 176 | |
| Overall Study | COMPLETED | S-1 + Cisplatin (Arm A) | 188 | |
| Overall Study | COMPLETED | Cisplatin (Arm B) | 176 | |
| Overall Study | NOT COMPLETED | S-1 + Cisplatin (Arm A) | 0 | |
| Overall Study | NOT COMPLETED | Cisplatin (Arm B) | 0 |
Source ClinicalTrials.gov
Adverse events258
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 | Abdominal distension | Gastrointestinal disorders | S-1 + Cisplatin (Arm A) | 12 | 188 | |
| other | Abdominal distension | Gastrointestinal disorders | Cisplatin (Arm B) | 5 | 175 | |
| other | Abdominal pain | Gastrointestinal disorders | S-1 + Cisplatin (Arm A) | 29 | 188 | |
| other | Abdominal pain | Gastrointestinal disorders | Cisplatin (Arm B) | 26 | 175 | |
| other | Abdominal pain upper | Gastrointestinal disorders | S-1 + Cisplatin (Arm A) | 24 | 188 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Cisplatin (Arm B) | 9 | 175 | |
| other | Constipation | Gastrointestinal disorders | S-1 + Cisplatin (Arm A) | 61 | 188 | |
| other | Constipation | Gastrointestinal disorders | Cisplatin (Arm B) | 48 | 175 | |
| other | Diarrhoea | Gastrointestinal disorders | S-1 + Cisplatin (Arm A) | 94 | 188 | |
| other | Diarrhoea | Gastrointestinal disorders | Cisplatin (Arm B) | 51 | 175 |
1 to 10 of 258Source ClinicalTrials.gov
See all 258 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | S-1 + Cisplatin (Arm A) | 7 | 188 |
| Total, all-cause mortality | Cisplatin (Arm B) | 3 | 175 |
| Total, other adverse events | S-1 + Cisplatin (Arm A) | 188 | 188 |
| Total, other adverse events | Cisplatin (Arm B) | 172 | 175 |
| Total, serious adverse events | S-1 + Cisplatin (Arm A) | 72 | 188 |
| Total, serious adverse events | Cisplatin (Arm B) | 34 | 175 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| S-1 + Cisplatin (Arm A) vs Cisplatin (Arm B): deaths from any cause | Trial comparisons |
| S-1 + Cisplatin (Arm A) vs Cisplatin (Arm B): 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/NCT00770874
GET https://conductscience.org/api/trials/v1/NCT00770874/events?page=2