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The Analyses of Treatment Efficacy and Cost-effectiveness in Early-staged Ovarian Cancer Patients

The Analyses of Treatment Efficacy and Cost-effectiveness in Early-staged Ovarian Cancer Patients Treated With or Without Paclitaxel Regimens

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03019315
Enrollment
5000
Registered
2017-01-12
Start date
2015-01-31
Completion date
2020-12-31
Last updated
2017-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Keywords

Ovarian Cancer, Chemotherapy, Response Rate, Survival

Brief 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 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.

Interventions

None listed

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* (1) diagnosed at early stage, (2) treated with primary cytoreductive surgery followed by adjuvant platinum based chemotherapy

Exclusion criteria

* (1)patients with a history of cancer (2)patients had insufficient clinic-pathological and survival data regarding to disease prognosis

Design outcomes

Primary

MeasureTime frame
progression free survival5 years

Secondary

MeasureTime frame
over all survival5 years
response rate6 months

Countries

Taiwan

Contacts

Primary ContactYing-Cheng Chiang, Ph.D.
littlechiang1878@yahoo.com.tw886-2-2312-3456
Backup ContactWen-Fang Cheng, Ph.D.
wenfangcheng@yahoo.com886-2-2312-3456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026