Cervical CancerPhase 3NCT02247232
Randomized Study of Z-100 Plus Radiation Therapy to Treat Cervical Cancer
A Phase 3 study testing Z-100 in people with Cervical Cancer, run by Zeria Pharmaceutical at 7 sites in 7 countries.
Trial summary
This study is a phase III, multicenter, double-blind, placebo-controlled, parallel group comparative study to evaluate the efficacy and safety of Z-100 with primary uterine cervical cancer on radiotherapy. The study will use a central randomization with a dynamic allocation using biased coin minimization. Read more about this study
- Who is it for?
- Ages 21 to 79 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Z-100
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 793 participants
- Where
- 7 sitesin 7 countries
- Study dates
- Dec 2014to 25 Feb 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 21 to 79 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- FIGO stage (2008): IIIB, cervical cancer;
- Pathologically confirmed squamous cell carcinoma of the cervix;
- Patients with treatment-naive cervical cancer;
- Patients without enlargement (≥15 mm in the short axis) in the lower abdominal para-aortic lymph node confirmed by CT scanning (Patients need not repeat CT scan at screening if CT data [film or electronic image] within 30 days before informed consent are available and can be provided for central imaging assessment);
- Patients ≥21, ≤79 years of age at informed consent;
- Patients for whom it is considered possible to carry out intracavitary radiation in radiotherapy;
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- Eastern Cooperative Oncology Group Performance Status: 0-2;
- Patients with the following organ functions; (1) WBC ≥3,000/mm3; (2) Platelet count ≥100,000/mm3; (3) Hemoglobin ≥9.5 g/dL (correction by blood transfusion is allowed); (4) Total bilirubin ≤ three (3) times the upper limit of reference value at the clinical testing laboratory; (5) AST, ALT ≤ three (3) times the upper limit of reference value at the clinical testing laboratory; (6) Renal function:
- If combination therapy with cisplatin is planned, creatinine clearance: ≥50 mL/min;
- If combination therapy with cisplatin is not planned, creatinine ≤ twice (2) the upper limit of reference value at the clinical testing laboratory;
- Patients who are willing to give informed consents. "
Who cannot join
None listed.
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
About this study
Official title: Randomized, Double-blind, Placebo-controlled Trial of Z-100 Plus Radiation Therapy in Patients With Locally Advanced Cervical Cancer - A Phase III Trial
This study is a phase III, multicenter, double-blind, placebo-controlled, parallel group comparative study to evaluate the efficacy and safety of Z-100 with primary uterine cervical cancer on radiotherapy. The study will use a central randomization with a dynamic allocation using biased coin minimization.
- Conditions
- Cervical Cancer
- Being tested
- Z-100, Placebo
- 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.
Z-100Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Z-100 | Experimental | Not described Receives: Drug: Z-100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 5Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2014 (estimated)
- Study startDec 2014
- Primary completion29 Jun 2021
- Study completion25 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 793 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeria Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keiichi Fujiwara, Prof,MD,PhD, Principal investigator, Saitama Medical University International Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02247232
- Sponsor's protocol ID
- Z100-01
- Status last verified
- Mar 2022
- First submitted
- 19 Sep 2014
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Trial of Z-100 Plus Radiation Therapy in Patients With Locally Advanced Cervical Cancer - A Phase III Trial
- ClinicalTrials.gov ID
- NCT02247232
- Acronym / sponsor ID
- Z100-01
- Conditions
- Cervical Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 793 participants (actual)
- Lead sponsor
- Zeria PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- 29 Jun 2021 (actual)
- Study completion
- 25 Feb 2022 (actual)
- First posted
- 23 Sep 2014 (estimated)
- Results
- Not posted in the source record
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 a phase III, multicenter, double-blind, placebo-controlled, parallel group comparative study to evaluate the efficacy and safety of Z-100 with primary uterine cervical cancer on radiotherapy. The study will use a central randomization with a dynamic allocation using biased coin minimization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Z-100 | Experimental | Drug: Z-100 |
Who may qualify
- Ages
- 21 to 79 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- FIGO stage (2008): IIIB, cervical cancer;
- Pathologically confirmed squamous cell carcinoma of the cervix;
- Patients with treatment-naive cervical cancer;
- Patients without enlargement (≥15 mm in the short axis) in the lower abdominal para-aortic lymph node confirmed by CT scanning (Patients need not repeat CT scan at screening if CT data [film or electronic image] within 30 days before informed consent are available and can be provided for central imaging assessment);
- Patients ≥21, ≤79 years of age at informed consent;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Z-100 | Drug | Z-100 |
| Placebo | Drug | Placebo |
Primary outcome
Overall survival
Time frame: 5Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
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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.
Keiichi Fujiwara, Prof,MD,PhD principal investigator
Saitama Medical University International Medical Center
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Z-100 in people with Cervical Cancer, run by Zeria Pharmaceutical at 7 sites in 7 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 11 inclusion and 0 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 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Japan, Malaysia, Singapore, South Korea, Taiwan and 2 more countries. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 5Years). 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 4 Mar 2022.