Cervical CancerPhase 3NCT00770874
Phase III Study of S-1 + Cisplatin vs Cisplatin in Cervical Cancer
A Phase 3 study testing S-1 + Cisplatin (arm A) and Cisplatin (arm B) in people with Cervical Cancer, run by Taiho Pharmaceutical Co., Ltd. at 4 sites in 3 countries.
Trial summary
This study is an open-label, multicenter, multinational, two-arm, parallel randomized Phase 3 study evaluating the efficacy and safety of S-1+Cisplatin versus single-agent Cisplatin in patients with stage IVB, recurrent or persistent carcinoma of the cervix. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- S-1 + Cisplatin (arm A) and Cisplatin (arm B)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Sep 2008to Apr 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically proven cervical carcinoma (All histological subtype will be included).
- Patients who have stage IVB, recurrent or persistent disease.
- Patients who are not amenable to curative treatment with surgery and/or radiotherapy.
- Patients who have not received chemotherapy or chemoradiotherapy after diagnosis of recurrent, persistent, or stage IVB disease.
- If the patient have received chemotherapy, radiotherapy or chemoradiotherapy as previous treatment, following interval must have elapsed from the last administration of treatment:
- Chemotherapy: 21 days
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- Radiotherapy: 21 days*
- Chemoradiotherapy: 42 days*
- If there have been residual disease in previously irradiated field and without disease progression since the (chemo) radiotherapy, 90 days must have elapsed after the last administration of irradiation.
- Patients who have adequate hematologic, hepatic and renal functions as defined below:
- Hemoglobin: ≥ 8.0 g/dL
- Neutrophil count: ≥ 2,000/mm^3
- Platelet count: ≥ 100,000/mm^3
- Total serum bilirubin: ≤ 1.5 times the upper limits of normal (ULN)
- AST (GOT), ALT (GPT): ≤ 2.5 times the ULN. If abnormal values are associated with hepatic metastasis: ≤ 5.0 times the ULN
- Serum creatinine: ≤ ULN or creatinine clearance: ≥ 50 ml/min
- Patients who have an ECOG performance status : 0-1.
- Age: ≥ 20 years old.
- Patients who can take pills orally.
- Patients who signed the written consent form.
Who cannot join
- Patients who have known hypersensitivity to 5-FU or Cisplatin.
- Patients who are receiving concomitant treatment with drugs interacting with S-1.
- Patients who are receiving concomitant treatment with drugs interacting with Cisplatin.
- Patients who were administered other investigational products within 30 days before the initiation of study treatment.
- Patients who were previously treated with S-1.
- Patients who had received platinum-containing chemotherapy or chemoradiotherapy and whose disease progressed during the therapy.
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- Patients who suffer from active infection (e.g. fever ≥ 38°C).
- Patients who have serious complications.
- Patients with bleeding which requires hemostasis treatment.
- Patients with bilateral hydronephrosis which cannot be alleviated by ureteral stents or percutaneous drainage.
- Patients with uncontrolled pleural effusion and/or ascites requiring drainage at least twice a week.
- Patients with symptomatic brain metastasis or history of brain metastasis.
- Patients who have unmanageable bowel movement (ex. Watery stool, chronic constipation).
- Patients with active double cancer.
- Patients who are pregnant or lactating.
- Patients who are considered to be inappropriate to the subject of this study by the investigator.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Japan2 sites
Cancer Institute Hospital
Ariake, Koto-ku, Tokyo, 135-8550
Yanagawa Hospital
Chikushimachi, Yanagawa, Fukuoka, 832-0077
South Korea1 site
Konkuk University Medical Center
Hwayang-dong, Gwangjin-gu, Seoul, 143-729
Taiwan1 site
Chang Gung Medical Foundation- Linkou
Fu-Hsing Saint Kuei Shan Hsiang, TaoYuan Hsien, 33305
About this study
Official title: Phase III Study of S-1 + Cisplatin Compared With Single-agent Cisplatin in Stage IVB, Recurrent, or Persistent Carcinoma of the Cervix
This study is an open-label, multicenter, multinational, two-arm, parallel randomized Phase 3 study evaluating the efficacy and safety of S-1+Cisplatin versus single-agent Cisplatin in patients with stage IVB, recurrent or persistent carcinoma of the cervix.
Read the detailed description
Japanese phase II study of S-1 in cervical cancer suggested promising response rate and good tolerability. Since recommended chemotherapy for metastatic or recurrent cervical carcinoma is either single-agent Cisplatin or Cisplatin-based combination chemotherapy, this is designed to evaluate the efficacy and safety of S-1 in combination with Cisplatin compared with single-agent Cisplatin.
- Conditions
- Cervical Cancer
- Being tested
- S-1 + Cisplatin (arm A), Cisplatin (arm B)
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1 + Cisplatin (arm A)Drug
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 (arm B)Drug
Cisplatin 50 mg/m2 will be administered intravenously (IV) on Day 1, repeated every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | S-1 + Cisplatin (arm A) Receives: Drug: S-1 + Cisplatin (arm A) |
| 2 | Active comparator | Cisplatin (arm B) Receives: Drug: Cisplatin (arm B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: 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 outcomes (1)
Progression Free Survival, Safety
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ken Takizawa, MD, Study chair, Cancer Institute HospitalToshiharu Kamura, MD, Study chair, Yanagawa HospitalTing-Chang Chang, MD, Study chair, Chang Gung Memorial HospitalSoon-Beom Kang, MD, Study chair, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00770874
- Sponsor's protocol ID
- 10020380
- Status last verified
- Mar 2019
- First submitted
- 9 Oct 2008
- Last updated
- 21 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of S-1 + Cisplatin Compared With Single-agent Cisplatin in Stage IVB, Recurrent, or Persistent Carcinoma of the Cervix
- ClinicalTrials.gov ID
- NCT00770874
- Acronym / sponsor ID
- 10020380
- Conditions
- Cervical Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Dec 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 10 Oct 2008 (estimated)
- Results
- Posted 21 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an open-label, multicenter, multinational, two-arm, parallel randomized Phase 3 study evaluating the efficacy and safety of S-1+Cisplatin versus single-agent Cisplatin in patients with stage IVB, recurrent or persistent carcinoma of the cervix.
Detailed description
Japanese phase II study of S-1 in cervical cancer suggested promising response rate and good tolerability. Since recommended chemotherapy for metastatic or recurrent cervical carcinoma is either single-agent Cisplatin or Cisplatin-based combination chemotherapy, this is designed to evaluate the efficacy and safety of S-1 in combination with Cisplatin compared with single-agent Cisplatin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: S-1 + Cisplatin (arm A)S-1 + Cisplatin (arm A) |
| 2 | Active comparator | Drug: Cisplatin (arm B)Cisplatin (arm B) |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patients with histologically proven cervical carcinoma (All histological subtype will be included).
- Patients who have stage IVB, recurrent or persistent disease.
- Patients who are not amenable to curative treatment with surgery and/or radiotherapy.
- Patients who have not received chemotherapy or chemoradiotherapy after diagnosis of recurrent, persistent, or stage IVB disease.
- If the patient have received chemotherapy, radiotherapy or chemoradiotherapy as previous treatment, following interval must have elapsed from the last administration of treatment:
Key exclusion criteria (16 listed)
- Patients who have known hypersensitivity to 5-FU or Cisplatin.
- Patients who are receiving concomitant treatment with drugs interacting with S-1.
- Patients who are receiving concomitant treatment with drugs interacting with Cisplatin.
- Patients who were administered other investigational products within 30 days before the initiation of study treatment.
- Patients who were previously treated with S-1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-1 + Cisplatin (arm A)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. | Drug | 1 |
| Cisplatin (arm B)Cisplatin 50 mg/m2 will be administered intravenously (IV) on Day 1, repeated every 3 weeks. | Drug | 2 |
Primary outcome
Overall Survival
Time frame: 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
1 secondary outcome
Progression Free Survival, Safety
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ken Takizawa, MD study chair
Cancer Institute Hospital
Toshiharu Kamura, MD study chair
Yanagawa Hospital
Ting-Chang Chang, MD study chair
Chang Gung Memorial Hospital
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing S-1 + Cisplatin (arm A) and Cisplatin (arm B) in people with Cervical Cancer, run by Taiho Pharmaceutical Co., Ltd. at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Japan, South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2019.