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Clinical Trials in China / NCT01820858
Active, not recruiting Phase 3

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

NCT01820858 · tracked via the Priya Life Science China tracker
Sponsor
Ding Ma
Phase
Phase 3
Started
2012-11
Last updated
2024-04-02

Condition(s) studied

Endometrial Neoplasms

Investigational drug(s) / intervention(s)

PaclitaxelParaplatin (Carboplatin Injection)Pelvic RadiationVaginal Brachytherapy 1Vaginal brachytherapy 2

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

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei
Qilu Hospital,Shandong University Jinan Shandong
Women's Hospital, School of Medicine, Zhejiang University Hangzhou Zhejiang

More Ding Ma trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01820858 on ClinicalTrials.gov ↗ ← All trials in China