Phase III Study of S-1 + Cisplatin vs Cisplatin in Cervical Cancer
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| ClinicalTrials.gov Identifier: NCT00770874 |
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Recruitment Status :
Completed
First Posted : October 10, 2008
Results First Posted : June 21, 2019
Last Update Posted : June 21, 2019
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Sponsor:
Taiho Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Taiho Pharmaceutical Co., Ltd.
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Cervical Cancer |
| Interventions |
Drug: S-1 + Cisplatin (arm A) Drug: Cisplatin (arm B) |
| Enrollment | 375 |
Participant Flow
| Recruitment Details | 375 patients were randomized to Arm A (189) or Arm B (186); of these, 364 patients(188 and 176, respectively) received study treatment. 11 patients (1 and 10, respectively) did not receive allocated intervention because of 'withdrew consent(1 and 6, respectively)' , 'ineligible criteria(3 in Arm B)', or 'investigator's discretion(1 in Arm B)'. |
| Pre-assignment Details |
| Arm/Group Title | S-1 + Cisplatin (Arm A) | Cisplatin (Arm B) |
|---|---|---|
 Arm/Group Description |
S-1 will be administered orally, twice daily from Day 1 through Day 14 followed by a recovery period from Days 15 through Day 21. Initial dose of S-1 will be determined according to the patient's body surface area (80 to 120 mg/day). On Day 1, Cisplatin 50 mg/m2 will be administered intravenously (IV). This regimen is to be repeated every 3 weeks. | Cisplatin 50 mg/m2 will be administered intravenously (IV) on Day 1, repeated every 3 weeks. |
| Period Title: Overall Study | ||
| Started | 188 | 176 |
| Completed | 188 | 176 |
| Not Completed | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | S-1 + Cisplatin (Arm A) | Cisplatin (Arm B) | Total | |
|---|---|---|---|---|
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Arm/Group Description |
S-1 will be administered orally, twice daily from Day 1 through Day 14 followed by a recovery period from Days 15 through Day 21. Initial dose of S-1 will be determined according to the patient's body surface area (80 to 120 mg/day). On Day 1, Cisplatin 50 mg/m2 will be administered intravenously (IV). This regimen is to be repeated every 3 weeks. | Cisplatin 50 mg/m2 will be administered intravenously (IV) on Day 1, repeated every 3 weeks. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 188 | 174 | 362 | |
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Baseline Analysis Population Description |
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. Two patients in Arm B were excluded in the efficacy analysis, because of insufficient informed consent, and missing efficacy data.
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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| Number Analyzed | 188 participants | 174 participants | 362 participants | |
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55
(27 to 84)
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52.5
(28 to 81)
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54
(27 to 84)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 188 participants | 174 participants | 362 participants | |
| Female |
188 100.0%
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174 100.0%
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362 100.0%
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| Male |
0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 188 participants | 174 participants | 362 participants |
| South Korea | 52 | 49 | 101 | |
| Japan | 110 | 105 | 215 | |
| Taiwan | 26 | 20 | 46 | |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | Taiho Pharmaceutical Co., Ltd. |
| Organization: | Clinical Trial Registration Contact |
| EMail: | toiawase@taiho.co.jp |
| Responsible Party: | Taiho Pharmaceutical Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT00770874 |
| Other Study ID Numbers: |
10020380 |
| First Submitted: | October 9, 2008 |
| First Posted: | October 10, 2008 |
| Results First Submitted: | October 22, 2018 |
| Results First Posted: | June 21, 2019 |
| Last Update Posted: | June 21, 2019 |