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Efficacy Study of Chemotherapy Followed by Radiation Therapy to Treat Endometrial Cancer

Primary Purpose

Endometrial Cancer

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Docetaxel
Cisplatin
Radiation therapy
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • One of following high risk groups Stage III after staging operation Stage II (Type I hysterectomy + BSO + LND) Stage I + two of [Grade III, LVSI+, Mm>1/2] Clear cell or serous carcinoma: stage IB-II
  • Age: 20-75
  • ECOG PS: 0-2
  • Adequate organ function BM: WBC ≥ 3,000/mm3, ANC≥1,500/mm3, Plt≥100X103/mm3, Hb≥10.0 g/dl Kidney: Creatinine <1.25 × UNL이고, GFR ≥ 60 Liver: AST, ALT< 3×UNL, T- bil<1.5 mg/ mm3
  • Informed Consent

Exclusion Criteria:

  • Previous chemotherapy or pelvic RT
  • Hormone therapy within 4 weeks
  • Other malignant disease
  • Uncontrolled medical disease
  • Infection requiring antibiotics
  • Symptomatic CHF, RF, Angina, Arrhythmia, etc.
  • Neurosis or psychosis
  • Etc.

Sites / Locations

  • Asan Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chemotherpay and radiation therapy

Arm Description

Docetaxel plus cisplatin followed by radiation therapy

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

Overall survival
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Quality of life

Full Information

First Posted
October 24, 2011
Last Updated
May 27, 2017
Sponsor
Asan Medical Center
Collaborators
Boryung Pharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01461746
Brief Title
Efficacy Study of Chemotherapy Followed by Radiation Therapy to Treat Endometrial Cancer
Official Title
A Phase II Trial of Docetaxel/Cisplatin Chemotherapy Followed by Pelvic Radiation Therapy in Patients, With High-risk Endometrial Carcinoma After Staging Surgery
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
Previous some studies suggested the addition of chemotherapy to radiation therapy after surgery may have survival benefit in patients with high risk endometrial cancer. In addition, docetaxel plus cisplatin regimen may have similar efficacy with paclitaxel plus carboplatin which is currently used in most cases. However, docetaxel plus cisplatin may cause less toxicity compared to paclitaxel plus carboplatin. Therefore, the investigators aimed to analyze the efficacy of docetaxel plus cisplatin regimen followed by radiation therapy after surgery in patients with high risk endometrial cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
67 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chemotherpay and radiation therapy
Arm Type
Experimental
Arm Description
Docetaxel plus cisplatin followed by radiation therapy
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Docetaxel 70mg/m2BSA, q 3 weeks, 3 cycles
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin 60mg/m2BSA, q 3 weeks, 3 cycles
Intervention Type
Radiation
Intervention Name(s)
Radiation therapy
Intervention Description
Pelvic radiation therapy (Extended filed radiation therapy and addition of brachytherapy is allowed)
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
2 years after completion of study treatment
Secondary Outcome Measure Information:
Title
Overall 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: One of following high risk groups Stage III after staging operation Stage II (Type I hysterectomy + BSO + LND) Stage I + two of [Grade III, LVSI+, Mm>1/2] Clear cell or serous carcinoma: stage IB-II Age: 20-75 ECOG PS: 0-2 Adequate organ function BM: WBC ≥ 3,000/mm3, ANC≥1,500/mm3, Plt≥100X103/mm3, Hb≥10.0 g/dl Kidney: Creatinine <1.25 × UNL이고, GFR ≥ 60 Liver: AST, ALT< 3×UNL, T- bil<1.5 mg/ mm3 Informed Consent Exclusion Criteria: Previous chemotherapy or pelvic RT Hormone therapy within 4 weeks Other malignant disease Uncontrolled medical disease Infection requiring antibiotics Symptomatic CHF, RF, Angina, Arrhythmia, etc. Neurosis or psychosis Etc.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joo-Hyun Nam, M.D., Ph.D.
Phone
+82-10-3010-3633
Email
jhnam@amc.seoul.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Jeong-Yeol Park, M.D., Ph.D.
Phone
+82-10-3010-3646
Email
obgyjypark@amc.seoul.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joo-Hyun Nam, M.D., Ph.D.
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
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
First Name & Middle Initial & Last Name & Degree
Jeong-Yeol Park, M.D., Ph.D.
Phone
+82-2-3010-3646
Email
obgyjypark@amc.seoul.kr

12. IPD Sharing Statement

Learn more about this trial

Efficacy Study of Chemotherapy Followed by Radiation Therapy to Treat Endometrial Cancer

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