Recurrent Ovarian CancerNCT01851746
A Study of Docetaxel and Lobaplatin Versus Docetaxel and Carboplatin Combination Regimen in Patients With Platinum-sensitive (>6 Months) Relapsed Ovarian Cancer
An observational study of Recurrent Ovarian Cancer, run by Wuhan University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the effectiveness and security of lobaplatin combined with docetaxel in treatment of the sensitive recurrent ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Recurrent Ovarian Cancer
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Mar 2013to Feb 2015
- Phase
- Observational
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: residents of a certain town
Who may be able to join
- age between 18 and 70 years old
- singed the information consent form
- Expected survival time >3 months
- Recurrence for at least 6 months after receiving initial platinum-based chemotherapy and without cytoreductive surgery indications.
Who cannot join
- Recurrence within 6 months after receiving initial platinum-based chemotherapy
- without radiographic evidence for tumor recurrence
- receiving other chemotherapy, hormone therapy, immunotherapy, or radiation therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of Docetaxel and Lobaplatin vs. Docetaxel and Carboplatin Combination Regimen in Patients With Platinum-sensitive (>6 Months) Relapsed Ovarian Cancer
The purpose of this study is to evaluate the effectiveness and security of lobaplatin combined with docetaxel in treatment of the sensitive recurrent ovarian cancer.
- Conditions
- Recurrent Ovarian Cancer
- Keywords
- recurrent ovarian cancer, lobaplatin, docetaxel, carboplatin
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of the effectiveness and security of lobaplatin combined with docetaxel in treatment of the sensitive recurrent ovarian cancer.
Blood routine, urine routine, hepatic and kidney function, electrolyte, ECG, CT,MRI
Measured: from pre-chemotherapy to 4-6 weeks post-chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2013 (estimated)
- Study startMar 2013
- Primary completionFeb 2015 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Ovarian 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HB Cai, Wuhan University
- Investigators
- Hong-bing Cai, MD,PhD, Study director, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01851746
- Sponsor's protocol ID
- CHB2013
- Status last verified
- May 2013
- First submitted
- 7 May 2013
- Last updated
- 10 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Docetaxel and Lobaplatin vs. Docetaxel and Carboplatin Combination Regimen in Patients With Platinum-sensitive (>6 Months) Relapsed Ovarian Cancer
- ClinicalTrials.gov ID
- NCT01851746
- Acronym / sponsor ID
- CHB2013
- Conditions
- Recurrent Ovarian Cancer
- Keywords
- recurrent ovarian cancer, lobaplatin, docetaxel, carboplatin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Wuhan UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 10 May 2013 (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.
The purpose of this study is to evaluate the effectiveness and security of lobaplatin combined with docetaxel in treatment of the sensitive recurrent ovarian cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- residents of a certain town
Key inclusion criteria (4 listed)
- age between 18 and 70 years old
- singed the information consent form
- Expected survival time >3 months
- Recurrence for at least 6 months after receiving initial platinum-based chemotherapy and without cytoreductive surgery indications.
Key exclusion criteria (3 listed)
- Recurrence within 6 months after receiving initial platinum-based chemotherapy
- without radiographic evidence for tumor recurrence
- receiving other chemotherapy, hormone therapy, immunotherapy, or radiation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evidence of the effectiveness and security of lobaplatin combined with docetaxel in treatment of the sensitive recurrent ovarian cancer.
Time frame: from pre-chemotherapy to 4-6 weeks post-chemotherapy
Blood routine, urine routine, hepatic and kidney function, electrolyte, ECG, CT,MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2013.
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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.
Hong-bing Cai, MD,PhD study director
Zhongnan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Ovarian Cancer, run by Wuhan University at 1 site in China.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
Are results available for this study?
Results are not available in the source record.
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?
Evidence of the effectiveness and security of lobaplatin combined with docetaxel in treatment of the sensitive recurrent ovarian cancer. (time frame: from pre-chemotherapy to 4-6 weeks post-chemotherapy). 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 10 May 2013.