Efficacy Study of Chemotherapy Followed by Radiation Therapy to Treat Endometrial Cancer
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ClinicalTrials.gov Identifier: NCT01461746 |
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 |
---|---|---|
Endometrial Cancer | Drug: Docetaxel Drug: Cisplatin Radiation: Radiation therapy | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 67 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 Chemotherapy Followed by Pelvic Radiation Therapy in Patients, With High-risk Endometrial Carcinoma After Staging Surgery |
Study Start Date : | October 2011 |
Estimated Primary Completion Date : | December 2017 |
Estimated Study Completion Date : | December 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Chemotherpay and radiation therapy
Docetaxel plus cisplatin followed by radiation therapy
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Drug: Docetaxel
Docetaxel 70mg/m2BSA, q 3 weeks, 3 cycles Drug: Cisplatin Cisplatin 60mg/m2BSA, q 3 weeks, 3 cycles Radiation: Radiation therapy Pelvic radiation therapy (Extended filed radiation therapy and addition of brachytherapy is allowed) |
- Progression-free survival [ Time Frame: 2 years after completion of study treatment ]
- Overall 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:
- 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.

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): NCT01461746
Contact: Joo-Hyun Nam, M.D., Ph.D. | +82-10-3010-3633 | jhnam@amc.seoul.kr | |
Contact: Jeong-Yeol Park, M.D., Ph.D. | +82-10-3010-3646 | 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 | |
Contact: Jeong-Yeol Park, M.D., Ph.D. +82-2-3010-3646 obgyjypark@amc.seoul.kr |
Principal Investigator: | Joo-Hyun Nam, M.D., Ph.D. | Asan Medical Center |
Responsible Party: | Joo-Hyun Nam, Professor, Asan Medical Center |
ClinicalTrials.gov Identifier: | NCT01461746 |
Other Study ID Numbers: |
ANSGOG-001 |
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 |
Docetaxel Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |