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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03019315
Recruitment Status : Recruiting
First Posted : January 12, 2017
Last Update Posted : January 16, 2017
Information provided by (Responsible Party):
National Taiwan University Hospital

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

Condition or disease
Ovarian Cancer

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.

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Primary Outcome Measures :
  1. progression free survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. over all survival [ Time Frame: 5 years ]
  2. response rate [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03019315

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Contact: Ying-Cheng Chiang, Ph.D. 886-2-2312-3456 ext 71964
Contact: Wen-Fang Cheng, Ph.D. 886-2-2312-3456 ext 71561

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National Taiwan University Recruiting
Taipei, Taiwan, 100
Contact: Wen-Fang Cheng, Ph.D.    886-2-2312-3456 ext 71561   
Sponsors and Collaborators
National Taiwan University Hospital
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Principal Investigator: Wen-Fang Cheng, Ph.D. Department of Obstetrics and Gynecology, College of Medicine, National Taiwan University, Taipei, Taiwan

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Responsible Party: National Taiwan University Hospital Identifier: NCT03019315    
Other Study ID Numbers: 201310006RIND
First Posted: January 12, 2017    Key Record Dates
Last Update Posted: January 16, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by National Taiwan University Hospital:
Ovarian Cancer
Response Rate
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type