Efficacy Study of Chemotherapy to Treat Advanced or Recurrent Endometrial Cancer
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ClinicalTrials.gov Identifier: NCT01461759 |
Recruitment Status : Unknown
Verified May 2017 by Joo-Hyun Nam, Asan Medical Center.
Recruitment status was: Recruiting
First Posted : October 28, 2011
Last Update Posted : May 31, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced or Recurrent Endometrial Cancer | Drug: Doctaxel Drug: Cisplatin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 59 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Trial of Docetaxel / Cisplatin in Patients With Recurrent or Stage IVb Endometrial Cancer |
Study Start Date : | October 2011 |
Estimated Primary Completion Date : | December 2017 |
Estimated Study Completion Date : | December 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Chemotherapy
Docetaxel 70mg/m2BSA + Cisplatin 60mg/m2BSA, q 3 weeks, 8cycles
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Drug: Doctaxel
Docetaxel 70mg/m2BSA, q 3 weeks, 8 cycles Drug: Cisplatin Cisplatin 60mg/m2BAS, q 3 weeks, 8 cycles |
- Response rate [ Time Frame: 3 months after completion of study treatment ]
- Progression-free survival [ Time Frame: 2 years after completion of study treatment ]
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Before each chemotherapy, an expected average of 3 weeks ]
- Quality of life [ Time Frame: 3 months after completion of study treatment ]

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Ages Eligible for Study: | 20 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461759
Contact: Joo-Hyun Nam, M.D., Ph.D. | +82-2-3010-3633 | jhnam@amc.seoul.kr | |
Contact: Jeong-Yeol Park, M.D., Ph.D. | +82-2-3010-3646 | obgyjypark@amc.seoul.kr |
Korea, Republic of | |
Asan Medical Center | Recruiting |
Seoul, Korea, Republic of, 138-736 | |
Contact: Joo-Hyun Nam, M.D., Ph.D +82-2-3010-3633 jhnam@amc.seoul.kr |
Responsible Party: | Joo-Hyun Nam, Professor, Asan Medical Center |
ClinicalTrials.gov Identifier: | NCT01461759 |
Other Study ID Numbers: |
ANSGOG-002 |
First Posted: | October 28, 2011 Key Record Dates |
Last Update Posted: | May 31, 2017 |
Last Verified: | May 2017 |
Endometrial Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site |
Neoplasms Uterine Diseases Cisplatin Antineoplastic Agents |