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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01886040
Other study ID # 102058-E
Secondary ID
Status Completed
Phase N/A
First received June 21, 2013
Last updated September 5, 2016
Start date June 2013
Est. completion date May 2016

Study information

Verified date February 2016
Source Far Eastern Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Observational

Clinical Trial Summary

Endometrial cancer is the second common gynecologic malignancy in Taiwan. The prevalence has been overcome the epithelial ovarian cancer because of the change of life style to western style recently. Most patients with endometrial cancer are stage I & II, the most histology is still "endometrioid adenocarcinoma" (type I endometrial cancer). In statistics, advanced stage (FIGO stage III and IV) is approximately 16% of all cases.

Most patients has good outcome of endometrial cancer because their surgical stage is belonged to "early stage". However, the recurrence, distant metastases and mortality are high if the diseases is confirmed to be advanced stage. The adjuvant therapies after staging/debulking operation are systemic chemotherapy and whole pelvic radiation therapy/ brachytherapy. Whether the adjuvant therapy can cure the disease of not is still controversial.

Because of the rarity of the advanced endometrial cancer, varies adjuvant therapeutic modalities, eg. chemotherapy only, pelvic radiation therapy only, combination of chemotherapy and radiation therapy or sequential "sandwich" therapy were ever used for such group patients in each medical center. But the case number is insufficient and limited to show the survival or progression free benefit during the statistics. Besides, the surgical procedures and adjuvant therapy for early endometrial cancer is still remained to be determined. The investigators are also interested to analyze the factors affecting their survival.

The investigators will perform a retrospective study to review the data of patients with endometrial cancer in Department of Obstetrics & Gynecology in Far Eastern Memorial Hospital.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 99 Years
Eligibility Inclusion Criteria:

1. Time interval: from 1991 to date.

2. Comprehensive surgical staging or debulking procedure.

3. All female patients with endometrial cancer who underwent surgery for endometrial cancer at Far Eastern Memorial Hospital.

Exclusion Criteria:

1. Not comprehensive staging/debulking procedure.

2. Patients who died of postoperative complications within 30 days after surgery were excluded from the survival analysis.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan Far Eastern Memorial Hospital Banqiao New Taipei

Sponsors (1)

Lead Sponsor Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Factors affecting overall survival and disease-free survival of endometrial cancer 20 years No
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