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

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: Endometrial Neoplasms
• Intervention / Treatment: Drug: Paclitaxel; Drug: Paraplatin (Carboplatin Injection); Radiation: Pelvic Radiation; Radiation: Vaginal Brachytherapy 1; Radiation: Vaginal brachytherapy 2

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital，Shandong University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Women's Hospital, School of Medicine, Zhejiang University

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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.	Drug: Paclitaxel; 175 mg/m(2), intravenously (IV); Drug: Paraplatin (Carboplatin Injection); AUC=5, IV
Active Comparator: Adjuvant Radiotherapy; 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.	Radiation: Pelvic Radiation; 45-50 Gy; Radiation: Vaginal Brachytherapy 1; 5 Gy, 3 times; Radiation: Vaginal brachytherapy 2; 5 Gy, 2-4 times

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disease-free survival (DFS)	3-year DFS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	3-month，6-month，1-year and 3-year
Complications of radiotherapy	To observe the subtle effect on quality of life (e.g., diarrhea, bowel symptoms) and vaginal stenosis.	3-month，6-month，1-year and 3-year
Quality of Life		3-month，6-month，1-year and 3-year
Overall survival (OS)		3-year OS

Collaborators and Investigators

• Sponsor: Ding Ma
• Collaborators: Shandong University; Huazhong University of Science and Technology; Zhejiang University
• Investigators: Study Chair: Beihua Kong, MD, PhD, Qilu Hospital, Shandong University

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 20, 2013
• First Submitted That Met QC Criteria: March 26, 2013
• First Posted (Estimated): March 29, 2013

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; 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