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

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ding Ma
• Collaborators: Huazhong University of Science and Technology; Shandong University; Zhejiang University
• Treatments: Carboplatin; Paclitaxel

Criteria

Inclusion Criteria:

• 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 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.