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Active, Not Recruiting

NCT Number: NCT01820858

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

paclitaxel

Drug

175 mg/m(2), intravenously (IV)

Paraplatin (Carboplatin Injection)

Drug

AUC=5, IV

Pelvic Radiation

Radiation

45-50 Gy

Vaginal Brachytherapy 1

Radiation

5 Gy, 3 times

Vaginal brachytherapy 2

Radiation

5 Gy, 2-4 times

Primary outcomes

  1. Disease-free survival (DFS)

    Time frame: 3-year DFS

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Ding Ma

Other

Collaborators

  • Huazhong University of Science and Technology
  • Shandong University
  • Zhejiang University

Registry information

Official study 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

Acronym: EC-01

Important dates

Study start
2012
Primary completion
2025
Study completion
2026
First posted
Mar 29, 2013
Registry last updated
Apr 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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