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

NCT ID: NCT01461746

Last Updated: 2017-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Endometrial Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chemotherpay and radiation therapy

Docetaxel plus cisplatin followed by radiation therapy

Group Type EXPERIMENTAL

Docetaxel

Intervention Type DRUG

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

Cisplatin

Intervention Type DRUG

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

Radiation therapy

Intervention Type RADIATION

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

Interventions

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Docetaxel

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

Intervention Type DRUG

Cisplatin

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

Intervention Type DRUG

Radiation therapy

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

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role collaborator

Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Joo-Hyun Nam

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joo-Hyun Nam, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Joo-Hyun Nam, M.D., Ph.D.

Role: CONTACT

+82-10-3010-3633

Jeong-Yeol Park, M.D., Ph.D.

Role: CONTACT

+82-10-3010-3646

Facility Contacts

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Joo-Hyun Nam, M.D., Ph.D.

Role: primary

+82-2-3010-3633

Jeong-Yeol Park, M.D., Ph.D.

Role: backup

+82-2-3010-3646

Other Identifiers

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ANSGOG-001

Identifier Type: -

Identifier Source: org_study_id

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