Back to resultsEfficacy Study of Chemotherapy to Treat Advanced or Recurrent Endometrial Cancer
Primary Purpose
Advanced or Recurrent Endometrial Cancer
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Doctaxel
Cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Advanced or Recurrent Endometrial Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed chemotherapy naïve endometrial cancer
- One of following histology Endometrioid, UPSC, CCCa, squamous, adenosquamous, mixed
- FIGO stage IVb or recurrent endometrial cancer (incurable by surgery and/or RT)
- At least one measurable lesion by RECIST on CT
- ECOG PS: 0-2
- Age: 20-75
- Adequate organ function BM: ANC≥1,000/mm3, Plt≥100X103/mm3 Kidney: Creatinine<1.25 × UNL이고, GFR ≥ 60 Liver: AST, ALT< 3×UNL, T- bil<1.5 mg/ mm3
- Informed Consent
- Contraception during study period
Exclusion Criteria:
- Previous chemotherapy
- RT, hormone therapy, or immunotherapy within 1 month
- Other malignant disease
- Uncontrolled medical disease
- Infection requiring antibiotics
- Symptomatic CHF, RF, Angina, Arrhythmia, etc.
- Neurosis or psychosis
- Pregnancy, breast-feeding
- Etc.
Sites / Locations
- Asan Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Chemotherapy
Arm Description
Docetaxel 70mg/m2BSA + Cisplatin 60mg/m2BSA, q 3 weeks, 8cycles
Outcomes
Primary Outcome Measures
Response rate
Secondary Outcome Measures
Progression-free survival
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Quality of life
Full Information
NCT ID
NCT01461759
First Posted
October 25, 2011
Last Updated
May 27, 2017
Sponsor
Asan Medical Center
Collaborators
Boryung Pharmaceutical Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT01461759
Brief Title
Efficacy Study of Chemotherapy to Treat Advanced or Recurrent Endometrial Cancer
Official Title
A Phase II Trial of Docetaxel / Cisplatin in Patients With Recurrent or Stage IVb Endometrial Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
Collaborators
Boryung Pharmaceutical Co., Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to treat advanced or recurrent endometrial cancer, paclitaxel-containing regimen is the preferred chemotherapeutic regimen which is selected by most physicians. Docetaxel may have similar efficacy and more favorable treatment related toxicity profile as tested in epithelial ovarian cancer trials. Therefore, the investigators aimed to evaluate the efficacy and safety of docetaxel plus cisplatin in patients with advanced or recurrent endometrial cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced or Recurrent Endometrial Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chemotherapy
Arm Type
Experimental
Arm Description
Docetaxel 70mg/m2BSA + Cisplatin 60mg/m2BSA, q 3 weeks, 8cycles
Intervention Type
Drug
Intervention Name(s)
Doctaxel
Intervention Description
Docetaxel 70mg/m2BSA, q 3 weeks, 8 cycles
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin 60mg/m2BAS, q 3 weeks, 8 cycles
Primary Outcome Measure Information:
Title
Response rate
Time Frame
3 months after completion of study treatment
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
2 years after completion of study treatment
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
Before each chemotherapy, an expected average of 3 weeks
Title
Quality of life
Time Frame
3 months after completion of study treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed chemotherapy naïve endometrial cancer
One of following histology Endometrioid, UPSC, CCCa, squamous, adenosquamous, mixed
FIGO stage IVb or recurrent endometrial cancer (incurable by surgery and/or RT)
At least one measurable lesion by RECIST on CT
ECOG PS: 0-2
Age: 20-75
Adequate organ function BM: ANC≥1,000/mm3, Plt≥100X103/mm3 Kidney: Creatinine<1.25 × UNL이고, GFR ≥ 60 Liver: AST, ALT< 3×UNL, T- bil<1.5 mg/ mm3
Informed Consent
Contraception during study period
Exclusion Criteria:
Previous chemotherapy
RT, hormone therapy, or immunotherapy within 1 month
Other malignant disease
Uncontrolled medical disease
Infection requiring antibiotics
Symptomatic CHF, RF, Angina, Arrhythmia, etc.
Neurosis or psychosis
Pregnancy, breast-feeding
Etc.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joo-Hyun Nam, M.D., Ph.D.
Phone
+82-2-3010-3633
Email
jhnam@amc.seoul.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Jeong-Yeol Park, M.D., Ph.D.
Phone
+82-2-3010-3646
Email
obgyjypark@amc.seoul.kr
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joo-Hyun Nam, M.D., Ph.D
Phone
+82-2-3010-3633
Email
jhnam@amc.seoul.kr
12. IPD Sharing Statement
Learn more about this trial
Efficacy Study of Chemotherapy to Treat Advanced or Recurrent Endometrial Cancer
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