The Analyses of Treatment Efficacy and Cost-effectiveness in Early-staged Ovarian Cancer Patients
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|ClinicalTrials.gov Identifier: NCT03019315|
Recruitment Status : Recruiting
First Posted : January 12, 2017
Last Update Posted : January 16, 2017
|Condition or disease|
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 Type :||Observational|
|Estimated Enrollment :||5000 participants|
|Official Title:||The Analyses of Treatment Efficacy and Cost-effectiveness in Early-staged Ovarian Cancer Patients Treated With or Without Paclitaxel Regimens|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
- progression free survival [ Time Frame: 5 years ]
- over all survival [ Time Frame: 5 years ]
- response rate [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03019315
|Contact: Ying-Cheng Chiang, Ph.D.||886-2-2312-3456 ext firstname.lastname@example.org|
|Contact: Wen-Fang Cheng, Ph.D.||886-2-2312-3456 ext email@example.com|
|National Taiwan University||Recruiting|
|Taipei, Taiwan, 100|
|Contact: Wen-Fang Cheng, Ph.D. 886-2-2312-3456 ext 71561 firstname.lastname@example.org|
|Principal Investigator:||Wen-Fang Cheng, Ph.D.||Department of Obstetrics and Gynecology, College of Medicine, National Taiwan University, Taipei, Taiwan|