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

NCT01820858 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-04-02

No results posted yet for this 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.

Conditions

  • Endometrial Neoplasms

Interventions

DRUG

Paclitaxel

175 mg/m(2), intravenously (IV)

DRUG

Paraplatin (Carboplatin Injection)

AUC=5, IV

RADIATION

Pelvic Radiation

45-50 Gy

RADIATION

Vaginal Brachytherapy 1

5 Gy, 3 times

RADIATION

Vaginal brachytherapy 2

5 Gy, 2-4 times

Sponsors & Collaborators

  • Shandong University

    collaborator OTHER

  • Huazhong University of Science and Technology

    collaborator OTHER

  • Zhejiang University

    collaborator OTHER

  • Ding Ma

    lead OTHER

Principal Investigators

  • Beihua Kong, MD, PhD · Qilu Hospital, Shandong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01820858 on ClinicalTrials.gov