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

Asan Medical Center

Status and phase: Unknown; Phase 2

Conditions: Endometrial Cancer

Treatments: Drug: Cisplatin; Radiation: Radiation therapy; Drug: Docetaxel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01461746

ANSGOG-001

Details and patient eligibility

About

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.

Enrollment: 67 estimated patients

Sex: Female

Ages: 20 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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67 participants in 1 patient group

Chemotherpay and radiation therapy

Experimental group

Description:

Docetaxel plus cisplatin followed by radiation therapy

Treatment:

Drug: Cisplatin

Drug: Docetaxel

Radiation: Radiation therapy