- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01820858
The Efficacy and Safety of the Postoperative Adjuvant Treatment in Patients With High-risk Stage I Endometrial Carcinoma (EC-01)
May 7, 2023 updated by: Ding Ma
A Multicenter, Prospective, Randomized Trial of the Efficacy and Safety of the Postoperative Adjuvant Treatment in Patients With High-risk Stage I Endometrial Carcinoma
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.
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hubei
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Wuhan, Hubei, China, 430030
- Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology
-
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Shandong
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Jinan, Shandong, China, 250012
- Qilu Hospital,Shandong University
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Zhejiang
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Hangzhou, Zhejiang, China, 310006
- Women's hospital, school of medicine, Zhejiang university
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Adjuvant Chemotherapy
Paclitaxel: 175 mg/m(2) intravenously (IV); followed by Paraplatin (Carboplatin Injection) AUC=5 IV. 3-6 cycles as necessary.
|
175 mg/m(2), intravenously (IV)
AUC=5, IV
|
Active Comparator: Adjuvant Radiotherapy
|
45-50 Gy
5 Gy, 3 times
5 Gy, 2-4 times
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disease-free survival (DFS)
Time Frame: 3-year DFS
|
3-year DFS
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Side effect of adjuvant chemotherapy
Time Frame: 3-month,6-month,1-year and 3-year
|
The incidence of infusion reactions (i.e.,skin reactions, cardiovascular reactions, respiratory or throat tightness), and allergic reactions (i.e., life-threatening anaphylaxis)
|
3-month,6-month,1-year and 3-year
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Complications of radiotherapy
Time Frame: 3-month,6-month,1-year and 3-year
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To observe the subtle effect on quality of life (e.g., diarrhea, bowel symptoms) and vaginal stenosis.
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3-month,6-month,1-year and 3-year
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Quality of Life
Time Frame: 3-month,6-month,1-year and 3-year
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3-month,6-month,1-year and 3-year
|
|
Overall survival (OS)
Time Frame: 3-year OS
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3-year OS
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Beihua Kong, MD, PhD, Qilu hospital, Shandong University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Anticipated)
December 1, 2023
Study Completion (Anticipated)
December 1, 2025
Study Registration Dates
First Submitted
March 20, 2013
First Submitted That Met QC Criteria
March 26, 2013
First Posted (Estimate)
March 29, 2013
Study Record Updates
Last Update Posted (Actual)
May 9, 2023
Last Update Submitted That Met QC Criteria
May 7, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Diseases
- Endometrial Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Carboplatin
- Paclitaxel
Other Study ID Numbers
- 2012-GYN/EC-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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