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

Primary Purpose

Endometrial Neoplasms

Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Paclitaxel
Paraplatin (Carboplatin Injection)
Pelvic Radiation
Vaginal Brachytherapy 1
Vaginal brachytherapy 2
Sponsored by
Ding Ma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Neoplasms

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Qilu Hospital，Shandong University
  • Women's Hospital, School of Medicine, Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adjuvant Chemotherapy

Adjuvant Radiotherapy

Arm Description

Paclitaxel: 175 mg/m(2) intravenously (IV); followed by Paraplatin (Carboplatin Injection) AUC=5 IV. 3-6 cycles as necessary.

Histopathological grade G3 and <50% myometrial invasion: Vaginal brachytherapy 5Gy, 3 times; Histopathological grade G3 and vascular space involvement: Pelvic radiation 45-50 Gy; ≥50% myometrial invasion: Pelvic radiation 50 Gy + Vaginal brachytherapy 5Gy, 2-4 times.

Outcomes

Primary Outcome Measures

Disease-free survival (DFS)

Secondary Outcome Measures

Side effect of adjuvant chemotherapy
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
To observe the subtle effect on quality of life (e.g., diarrhea, bowel symptoms) and vaginal stenosis.
Quality of Life
Overall survival (OS)

Full Information

First Posted
March 20, 2013
Last Updated
May 7, 2023
Sponsor
Ding Ma
Collaborators
Shandong University, Huazhong University of Science and Technology, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT01820858
Brief Title
The Efficacy and Safety of the Postoperative Adjuvant Treatment in Patients With High-risk Stage I Endometrial Carcinoma
Acronym
EC-01
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 Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ding Ma
Collaborators
Shandong University, Huazhong University of Science and Technology, Zhejiang University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adjuvant Chemotherapy
Arm Type
Experimental
Arm Description
Paclitaxel: 175 mg/m(2) intravenously (IV); followed by Paraplatin (Carboplatin Injection) AUC=5 IV. 3-6 cycles as necessary.
Arm Title
Adjuvant Radiotherapy
Arm Type
Active Comparator
Arm Description
Histopathological grade G3 and <50% myometrial invasion: Vaginal brachytherapy 5Gy, 3 times; Histopathological grade G3 and vascular space involvement: Pelvic radiation 45-50 Gy; ≥50% myometrial invasion: Pelvic radiation 50 Gy + Vaginal brachytherapy 5Gy, 2-4 times.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
175 mg/m(2), intravenously (IV)
Intervention Type
Drug
Intervention Name(s)
Paraplatin (Carboplatin Injection)
Intervention Description
AUC=5, IV
Intervention Type
Radiation
Intervention Name(s)
Pelvic Radiation
Intervention Description
45-50 Gy
Intervention Type
Radiation
Intervention Name(s)
Vaginal Brachytherapy 1
Intervention Description
5 Gy, 3 times
Intervention Type
Radiation
Intervention Name(s)
Vaginal brachytherapy 2
Intervention Description
5 Gy, 2-4 times
Primary Outcome Measure Information:
Title
Disease-free survival (DFS)
Time Frame
3-year DFS
Secondary Outcome Measure Information:
Title
Side effect of adjuvant chemotherapy
Description
The incidence of infusion reactions (i.e.,skin reactions, cardiovascular reactions, respiratory or throat tightness), and allergic reactions (i.e., life-threatening anaphylaxis)
Time Frame
3-month，6-month，1-year and 3-year
Title
Complications of radiotherapy
Description
To observe the subtle effect on quality of life (e.g., diarrhea, bowel symptoms) and vaginal stenosis.
Time Frame
3-month，6-month，1-year and 3-year
Title
Quality of Life
Time Frame
3-month，6-month，1-year and 3-year
Title
Overall survival (OS)
Time Frame
3-year OS

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beihua Kong, MD, PhD
Organizational Affiliation
Qilu Hospital, Shandong University
Official's Role
Study Chair
Facility Information:
Facility Name
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Qilu Hospital，Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Name
Women's Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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