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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Huazhong University of Science and Technology
Sponsor:
Collaborators:
Shandong University
Huazhong University of Science and Technology
Zhejiang University
Information provided by (Responsible Party):
Ding Ma, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01820858
First received: March 20, 2013
Last updated: March 26, 2013
Last verified: March 2013
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Huazhong University of Science and Technology:

Primary Outcome Measures:
  • Disease-free survival (DFS) [ Time Frame: 3-year DFS ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Side effect of adjuvant chemotherapy [ Time Frame: 3-month,6-month,1-year and 3-year ] [ Designated as safety issue: No ]
    The incidence of infusion reactions (i.e.,skin reactions, cardiovascular reactions, respiratory or throat tightness), and allergic reactions (i.e., life-threatening anaphylaxis)

  • Complications of radiotherapy [ Time Frame: 3-month,6-month,1-year and 3-year ] [ Designated as safety issue: No ]
    To observe the subtle effect on quality of life (e.g., diarrhea, bowel symptoms) and vaginal stenosis.

  • Quality of Life [ Time Frame: 3-month,6-month,1-year and 3-year ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: 3-year OS ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: November 2012
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
AUC=5, IV
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01820858

Contacts
Contact: Danhui Weng, MD, PhD +862783662681 weng.dh@gmail.com

Locations
China, Hubei
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430030
Contact: Danhui Weng, MD    +862783662681    weng.dh@gmail.com   
Principal Investigator: Changyu Wang, MD         
China, Shandong
Qilu Hospital,Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Xingsheng Yang, MD, Ph D    13791123129    xingshengyang@yahoo.com   
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    maoyy3@yahoo.com.cn   
Principal Investigator: Yuyan Mao, MD         
Sponsors and Collaborators
Ding Ma
Shandong University
Huazhong University of Science and Technology
Zhejiang University
Investigators
Study Chair: Beihua Kong, MD, PhD Qilu Hospital, Shandong University
  More Information

No publications provided

Responsible Party: Ding Ma, Director of the department of Obstetrics and Gynecology, Tongji Hospital, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT01820858     History of Changes
Other Study ID Numbers: 2012-GYN/EC-01
Study First Received: March 20, 2013
Last Updated: March 26, 2013
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Endometrial Neoplasms
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014