NCT01886040

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

September 7, 2016

Status Verified

February 1, 2016

Enrollment Period

2.9 years

First QC Date

June 21, 2013

Last Update Submit

September 5, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Factors affecting overall survival and disease-free survival of endometrial cancer

    20 years

Study Arms (1)

cases with endometrial cancer

Eligibility Criteria

Age20 Years - 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

the cases with endometrial cancer

You may qualify if:

  • Time interval: from 1991 to date.
  • Comprehensive surgical staging or debulking procedure.
  • All female patients with endometrial cancer who underwent surgery for endometrial cancer at Far Eastern Memorial Hospital.

You may not qualify if:

  • Not comprehensive staging/debulking procedure.
  • Patients who died of postoperative complications within 30 days after surgery were excluded from the survival analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Department of Obstetrics & Gynecology

Study Record Dates

First Submitted

June 21, 2013

First Posted

June 25, 2013

Study Start

June 1, 2013

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

September 7, 2016

Record last verified: 2016-02

Locations