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

A Multicenter, Prospective, Randomized Trial of the Efficacy and Safety of the Postoperative Adjuvant Treatment in Patients With High-risk Stage I Endometrial Carcinoma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01820858

Acronym

EC-01

Enrollment

300

Registered

2013-03-29

Start date

2012-11-30

Completion date

2026-12-31

Last updated

2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Neoplasms

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.

Interventions

DRUGPaclitaxel

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

DRUGParaplatin (Carboplatin Injection)

AUC=5, IV

RADIATIONPelvic Radiation

45-50 Gy

RADIATIONVaginal Brachytherapy 1

5 Gy, 3 times

RADIATIONVaginal brachytherapy 2

5 Gy, 2-4 times

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame
Disease-free survival (DFS)	3-year DFS

Secondary

Measure	Time frame	Description
Side effect of adjuvant chemotherapy	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)
Complications of radiotherapy	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.
Quality of Life	3-month，6-month，1-year and 3-year	—
Overall survival (OS)	3-year OS	—

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026