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

Endometrial Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01461746
• Other study ID #: ANSGOG-001
• Status: Recruiting
• Phase: Phase 2
• First received: October 24, 2011
• Last updated: May 27, 2017
• Start date: October 2011
• Est. completion date: December 2017

Study information

• Verified date: May 2017
• Source: Asan Medical Center
• Contact: Joo-Hyun Nam, M.D., Ph.D.
• Phone: +82-10-3010-3633
• Email: jhnam[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 67
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 75 Years

Eligibility

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 × UNL??, 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.

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Drug:
• Docetaxel
Docetaxel 70mg/m2BSA, q 3 weeks, 3 cycles
• 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)

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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