The Efficacy and Safety of the Postoperative Adjuvant Treatment in Patients With High-risk Stage I Endometrial Carcinoma
NCT ID: NCT01820858
Last Updated: 2024-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
300 participants
INTERVENTIONAL
2012-11-30
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Adjuvant Chemotherapy
Paclitaxel: 175 mg/m(2) intravenously (IV); followed by Paraplatin (Carboplatin Injection) AUC=5 IV. 3-6 cycles as necessary.
Paclitaxel
175 mg/m(2), intravenously (IV)
Paraplatin (Carboplatin Injection)
AUC=5, IV
Adjuvant Radiotherapy
1. Histopathological grade G3 and \<50% myometrial invasion: Vaginal brachytherapy 5Gy, 3 times;
2. Histopathological grade G3 and vascular space involvement: Pelvic radiation 45-50 Gy;
3. ≥50% myometrial invasion: Pelvic radiation 50 Gy + Vaginal brachytherapy 5Gy, 2-4 times.
Pelvic Radiation
45-50 Gy
Vaginal Brachytherapy 1
5 Gy, 3 times
Vaginal brachytherapy 2
5 Gy, 2-4 times
Interventions
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Paclitaxel
175 mg/m(2), intravenously (IV)
Paraplatin (Carboplatin Injection)
AUC=5, IV
Pelvic Radiation
45-50 Gy
Vaginal Brachytherapy 1
5 Gy, 3 times
Vaginal brachytherapy 2
5 Gy, 2-4 times
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
FEMALE
No
Sponsors
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Shandong University
OTHER
Huazhong University of Science and Technology
OTHER
Zhejiang University
OTHER
Ding Ma
OTHER
Responsible Party
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Ding Ma
Director of the department of Obstetrics and Gynecology, Tongji Hospital
Principal Investigators
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Beihua Kong, MD, PhD
Role: STUDY_CHAIR
Qilu Hospital, Shandong University
Locations
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Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Qilu Hospital，Shandong University
Jinan, Shandong, China
Women's Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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2012-GYN/EC-01
Identifier Type: -
Identifier Source: org_study_id
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