Overview

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

Status:
Unknown status
Trial end date:
2017-12-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Asan Medical Center
Collaborator:
Boryung Pharmaceutical Co., Ltd
Treatments:
Cisplatin
Docetaxel
Criteria
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.