Ovarian CancerNCT03019315
The Analyses of Treatment Efficacy and Cost-effectiveness in Early-staged Ovarian Cancer Patients
An observational study of Ovarian Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Adjuvant chemotherapy was introduced in patients with early-stage ovarian cancer. The benefit of standard chemotherapeutic regimens including taxane has not been established. This study was conducted to investigate the influences of regimens of front-line chemotherapy on on recurrence and survival for early-stage… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- How many people
- 5,000 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2015to Dec 2020
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Ovarian cancer patients diagnosed between 1 January 1999 and 31 December 2020 without a history of cancer were identified from the catastrophic illness registry.
Who may be able to join
- (1) diagnosed at early stage, (2) treated with primary cytoreductive surgery followed by adjuvant platinum based chemotherapy
Who cannot join
- (1)patients with a history of cancer (2)patients had insufficient clinic-pathological and survival data regarding to disease prognosis
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University
Taipei, 100
Wen-Fang Cheng, Ph.D., 886-2-2312-3456 ext. 71561, wenfangcheng@yahoo.com
About this study
Official title: The Analyses of Treatment Efficacy and Cost-effectiveness in Early-staged Ovarian Cancer Patients Treated With or Without Paclitaxel Regimens
Adjuvant chemotherapy was introduced in patients with early-stage ovarian cancer. The benefit of standard chemotherapeutic regimens including taxane has not been established. This study was conducted to investigate the influences of regimens of front-line chemotherapy on on recurrence and survival for early-stage ovarian adenocarcinoma. Further, the study will analyze cost-effectiveness of different regimens
Read the detailed description
Ovarian carcinoma has become more and more important in recent years because it is the leading cause of death among all gynecologic malignancies. The annual incidence rate of ovarian cancer in the United States was 11.8 per 100,000 and the death rate was 7.8 per 100,000 in 2009. According to the Department of Health Bureau's report, the incidence rate of ovarian cancer was 8.46 per 100,000 in 2010 and the death rate was 2.8 per 100,000. No specific symptoms, difficulty in early diagnosis, insufficient accurate tumor markers, and a lack of information regarding ovarian tumor biology all contribute to a poor prognosis.
The standard treatment for ovarian cancer is surgical tumor debulking, followed by platinum-containing chemotherapy. The conventional adjuvant chemotherapeutic regimens of ovarian cancer are platinum combined with cyclophosphamide. Whereas, platinum combined with paclitaxel has been identified to be a better adjuvant chemotherapeutic regimens for those advance-staged disease. In United States, platinum combined with paclitaxel has been used as standard adjuvant chemotherapeutic regimens for all of ovarian cancer patients for decades. However, many countries including Taiwan still use platinum combined with cyclophosphamide as adjuvant chemotherapeutic regimens for early-staged ovarian cancer patients. There is no comprehensive result to demonstrate the differences between these two regimens the fields of efficacy, side effects, survival, cost-effectiveness, and so on. So the investigators conduct this study to answer the questions. This study will firstly focus on the early-staged ovarian cancer patients to analyze the data from the National Health Insurance (NHI) databank. Further this study will then validate the results from NHI databank from the cancer registration system of National Taiwan University Hospital.
There are several aims in this proposal. First, the study will evaluate the differences of efficacy including the response rate, side effects, disease-free survival, and overall survival of the patients between these two chemotherapeutic regimens. Second, the cost-effectiveness of these two chemotherapeutic regimens will be identified. The results of this study will provide a more comprehensive picture of selecting optimal chemotherapeutic regimens for early-staged ovarian cancer patients. It can also be an important reference for the pay-off of National Health Insurance.
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian Cancer, Chemotherapy, Response Rate, Survival
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
Measured: 5 years
Secondary outcomes (2)
over all survival
Measured: 5 years
response rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startJan 2015
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen-Fang Cheng, Ph.D., Principal investigator, Department of Obstetrics and Gynecology, College of Medicine, National Taiwan University, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019315
- Sponsor's protocol ID
- 201310006RIND
- Status last verified
- Jan 2017
- First submitted
- 10 Jan 2017
- Last updated
- 16 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analyses of Treatment Efficacy and Cost-effectiveness in Early-staged Ovarian Cancer Patients Treated With or Without Paclitaxel Regimens
- ClinicalTrials.gov ID
- NCT03019315
- Acronym / sponsor ID
- 201310006RIND
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian Cancer, Chemotherapy, Response Rate, Survival
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 12 Jan 2017 (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.
Adjuvant chemotherapy was introduced in patients with early-stage ovarian cancer. The benefit of standard chemotherapeutic regimens including taxane has not been established. This study was conducted to investigate the influences of regimens of front-line chemotherapy on on recurrence and survival for early-stage ovarian adenocarcinoma. Further, the study will analyze cost-effectiveness of different regimens
Detailed description
Ovarian carcinoma has become more and more important in recent years because it is the leading cause of death among all gynecologic malignancies. The annual incidence rate of ovarian cancer in the United States was 11.8 per 100,000 and the death rate was 7.8 per 100,000 in 2009. According to the Department of Health Bureau's report, the incidence rate of ovarian cancer was 8.46 per 100,000 in 2010 and the death rate was 2.8 per 100,000. No specific symptoms, difficulty in early diagnosis, insufficient accurate tumor markers, and a lack of information regarding ovarian tumor biology all contribute to a poor prognosis.
The standard treatment for ovarian cancer is surgical tumor debulking, followed by platinum-containing chemotherapy. The conventional adjuvant chemotherapeutic regimens of ovarian cancer are platinum combined with cyclophosphamide. Whereas, platinum combined with paclitaxel has been identified to be a better adjuvant chemotherapeutic regimens for those advance-staged disease. In United States, platinum combined with paclitaxel has been used as standard adjuvant chemotherapeutic regimens for all of ovarian cancer patients for decades. However, many countries including Taiwan still use platinum combined with cyclophosphamide as adjuvant chemotherapeutic regimens for early-staged ovarian cancer patients. There is no comprehensive result to demonstrate the differences between these two regimens the fields of efficacy, side effects, survival, cost-effectiveness, and so on. So the investigators conduct this study to answer the questions. This study will firstly focus on the early-staged ovarian cancer patients to analyze the data from the National Health Insurance (NHI) databank. Further this study will then validate the results from NHI databank from the cancer registration system of National Taiwan University Hospital.
There are several aims in this proposal. First, the study will evaluate the differences of efficacy including the response rate, side effects, disease-free survival, and overall survival of the patients between these two chemotherapeutic regimens. Second, the cost-effectiveness of these two chemotherapeutic regimens will be identified. The results of this study will provide a more comprehensive picture of selecting optimal chemotherapeutic regimens for early-staged ovarian cancer patients. It can also be an important reference for the pay-off of National Health Insurance.
Study design
- Observational model
- Cohort
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ovarian cancer patients diagnosed between 1 January 1999 and 31 December 2020 without a history of cancer were identified from the catastrophic illness registry.
Key inclusion criteria (1 listed)
- (1) diagnosed at early stage, (2) treated with primary cytoreductive surgery followed by adjuvant platinum based chemotherapy
Key exclusion criteria (1 listed)
- (1)patients with a history of cancer (2)patients had insufficient clinic-pathological and survival data regarding to disease prognosis
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
progression free survival
Time frame: 5 years
2 secondary outcomes
over all survival
Time frame: 5 years
response rate
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2017.
- Individual participant dataSharing planned: No
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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.
Wen-Fang Cheng, Ph.D. principal investigator
Department of Obstetrics and Gynecology, College of Medicine, National Taiwan University, Taipei, Taiwan
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 Ovarian Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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 16 Jan 2017. 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 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.
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?
Contact Ying-Cheng Chiang, Ph.D. (886-2-2312-3456 ext. 71964, littlechiang1878@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (time frame: 5 years). 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 16 Jan 2017.