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

A Phase II Trial of Docetaxel/Cisplatin Chemotherapy Followed by Pelvic Radiation Therapy in Patients, With High-risk Endometrial Carcinoma After Staging Surgery

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01461746

Enrollment

Registered

2011-10-28

Start date

2011-10-31

Completion date

2017-12-31

Last updated

2017-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer

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.

Interventions

DRUGDocetaxel

Docetaxel 70mg/m2BSA, q 3 weeks, 3 cycles

DRUGCisplatin

Cisplatin 60mg/m2BSA, q 3 weeks, 3 cycles

RADIATIONRadiation therapy

Pelvic radiation therapy (Extended filed radiation therapy and addition of brachytherapy is allowed)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame
Progression-free survival	2 years after completion of study treatment

Secondary

Measure	Time frame
Overall survival	2 years after completion of study treatment
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Before each chemotherapy, an expected average of 3 weeks
Quality of life	3 months after completion of study treatment

Countries

South Korea

Contacts

Primary ContactJoo-Hyun Nam, M.D., Ph.D.

jhnam@amc.seoul.kr+82-10-3010-3633

Backup ContactJeong-Yeol Park, M.D., Ph.D.

obgyjypark@amc.seoul.kr+82-10-3010-3646

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026