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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Progression-free survival
Secondary Outcome
Overall survival
Condition
Endometrial Cancer
Intervention
Docetaxel
Study Arms / Comparison Groups
Chemotherpay and radiation therapy
Description: Docetaxel plus cisplatin followed by radiation therapy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
67
Start Date
October 2011
Completion Date
December 2017
Primary Completion Date
December 2017
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.
Gender
Female
Ages
20 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Joo-Hyun Nam, M.D., Ph.D., +82-10-3010-3633, [email protected]
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT01461746
Organization ID
ANSGOG-001
Responsible Party
Principal Investigator
Study Sponsor
Asan Medical Center
Collaborators
Boryung Pharmaceutical Co., Ltd
Study Sponsor
Joo-Hyun Nam, M.D., Ph.D., Principal Investigator, Asan Medical Center
Verification Date
May 2017