Status:
ACTIVE_NOT_RECRUITING
The Efficacy and Safety of the Postoperative Adjuvant Treatment in Patients With High-risk Stage I Endometrial Carcinoma
Lead Sponsor:
Ding Ma
Collaborating Sponsors:
Shandong University
Huazhong University of Science and Technology
Conditions:
Endometrial Neoplasms
Eligibility:
FEMALE
18-65 years
Phase:
PHASE3
Brief 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 endomet...
Eligibility Criteria
Inclusion
- FIGO stage: Ⅰ, 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: ① histopathological grading in poorly differentiated: G3; ② ≥50% myometrial invasion; ③ vascular space involvement;
- No prior treatment;
- Provide written informed consent.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01820858
Start Date
November 1 2012
End Date
December 1 2026
Last Update
April 2 2024
Active Locations (3)
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1
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
2
Qilu Hospital，Shandong University
Jinan, Shandong, China, 250012
3
Women's Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310006