The Efficacy and Safety of the Postoperative Adjuvant Treatment in Patients With High-risk Stage I Endometrial Carcinoma (EC-01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01820858
Recruitment Status : Recruiting
First Posted : March 29, 2013
Last Update Posted : May 28, 2018
Shandong University
Huazhong University of Science and Technology
Zhejiang University
Information provided by (Responsible Party):
Ding Ma, Huazhong University of Science and Technology

Brief 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.

Condition or disease Intervention/treatment Phase
Endometrial Neoplasms Drug: Paclitaxel Drug: Paraplatin (Carboplatin Injection) Radiation: Pelvic Radiation Radiation: Vaginal Brachytherapy 1 Radiation: Vaginal brachytherapy 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Prospective, Randomized Trial of the Efficacy and Safety of the Postoperative Adjuvant Treatment in Patients With High-risk Stage I Endometrial Carcinoma
Study Start Date : November 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

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.
Drug: Paclitaxel
175 mg/m(2), intravenously (IV)

Drug: Paraplatin (Carboplatin Injection)

Active Comparator: 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.
Radiation: Pelvic Radiation
45-50 Gy

Radiation: Vaginal Brachytherapy 1
5 Gy, 3 times

Radiation: Vaginal brachytherapy 2
5 Gy, 2-4 times

Primary Outcome Measures :
  1. Disease-free survival (DFS) [ Time Frame: 3-year DFS ]

Secondary Outcome Measures :
  1. 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)

  2. Complications of radiotherapy [ Time Frame: 3-month,6-month,1-year and 3-year ]
    To observe the subtle effect on quality of life (e.g., diarrhea, bowel symptoms) and vaginal stenosis.

  3. Quality of Life [ Time Frame: 3-month,6-month,1-year and 3-year ]
  4. Overall survival (OS) [ Time Frame: 3-year OS ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01820858

Contact: Danhui Weng, MD, PhD +862783662681

China, Hubei
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430030
Contact: Danhui Weng, MD    +862783662681   
Principal Investigator: Changyu Wang, MD         
China, Shandong
Qilu Hospital,Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Xingsheng Yang, MD, Ph D    13791123129   
Principal Investigator: Xingsheng Yang, MD         
China, Zhejiang
Women's Hospital, School of Medicine, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310006
Contact: Yuyan Mao, MD    13989816955   
Principal Investigator: Yuyan Mao, MD         
Sponsors and Collaborators
Ding Ma
Shandong University
Huazhong University of Science and Technology
Zhejiang University
Study Chair: Beihua Kong, MD, PhD Qilu Hospital, Shandong University

Responsible Party: Ding Ma, Director of the department of Obstetrics and Gynecology, Tongji Hospital, Huazhong University of Science and Technology Identifier: NCT01820858     History of Changes
Other Study ID Numbers: 2012-GYN/EC-01
First Posted: March 29, 2013    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: October 2017

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action