The Efficacy and Safety of the Postoperative Adjuvant Treatment in Patients With High-risk Stage I Endometrial Carcinoma

Endometrial Neoplasms Clinical Trial

— EC-01  

Official title:

A Multicenter, Prospective, Randomized Trial of the Efficacy and Safety of the Postoperative Adjuvant Treatment in Patients With High-risk Stage I Endometrial Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01820858
• Other study ID #: 2012-GYN/EC-01
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 2012
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized trial is studying the efficacy and safety of the chemotherapy compared with radiation therapy alone as adjuvant treatment after operation in Patients with high risk and Stage I endometrial carcinoma.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• FIGO stage: ?, endometrial carcinoma;
• Female, Chinese women;
• Initial treatment is staging surgery;
• Pathological diagnosis: Endometrial adenocarcinoma;
• Pathologic examination and meet the following one of the indications of adjuvant therapy: ? histopathological grading in poorly differentiated: G3; ? =50% myometrial invasion; ? vascular space involvement;
• No prior treatment;
• Provide written informed consent.

Exclusion Criteria:

• Unable to receive surgery and/or unsuitable for radiotherapy or chemotherapy;
• Family history of ovarian cancer;
• Suffering from other malignancies;
• Concurrently participating in other clinical trials;
• Unable or unwilling to sign informed consents;
• Unable or unwilling to abide by protocol.

Related Conditions & MeSH terms

• Endometrial Neoplasms

Intervention

Drug:
• Paclitaxel
175 mg/m(2), intravenously (IV)
• Paraplatin (Carboplatin Injection)
AUC=5, IV

Radiation:
• Pelvic Radiation
45-50 Gy
• Vaginal Brachytherapy 1
5 Gy, 3 times
• Vaginal brachytherapy 2
5 Gy, 2-4 times

Locations

Country	Name	City	State
China	Women's Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	Qilu Hospital,Shandong University	Jinan	Shandong
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (4)

Lead Sponsor	Collaborator
Ding Ma	Huazhong University of Science and Technology, Shandong University, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival (DFS)		3-year DFS
Secondary	Side effect of adjuvant chemotherapy	The incidence of infusion reactions (i.e.,skin reactions, cardiovascular reactions, respiratory or throat tightness), and allergic reactions (i.e., life-threatening anaphylaxis)	3-month,6-month,1-year and 3-year
Secondary	Complications of radiotherapy	To observe the subtle effect on quality of life (e.g., diarrhea, bowel symptoms) and vaginal stenosis.	3-month,6-month,1-year and 3-year
Secondary	Quality of Life		3-month,6-month,1-year and 3-year
Secondary	Overall survival (OS)		3-year OS