NCT01820858

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
6mo left

Started Nov 2012

Longer than P75 for phase_3

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Nov 2012Dec 2026

Study Start

First participant enrolled

November 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 29, 2013

Completed
12.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

April 2, 2024

Status Verified

April 1, 2024

Enrollment Period

13.1 years

First QC Date

March 20, 2013

Last Update Submit

April 1, 2024

Conditions

Endometrial Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival (DFS)

    3-year DFS

Secondary Outcomes (4)

  • Side effect of adjuvant chemotherapy

    3-month，6-month，1-year and 3-year

  • Complications of radiotherapy

    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

Study Arms (2)

Adjuvant Chemotherapy

EXPERIMENTAL

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

Drug: PaclitaxelDrug: Paraplatin (Carboplatin Injection)

Adjuvant Radiotherapy

ACTIVE COMPARATOR

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 RadiationRadiation: Vaginal Brachytherapy 1Radiation: Vaginal brachytherapy 2

Interventions

PaclitaxelDRUG

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

Adjuvant Chemotherapy
Paraplatin (Carboplatin Injection)DRUG

AUC=5, IV

Adjuvant Chemotherapy
Pelvic RadiationRADIATION

45-50 Gy

Adjuvant Radiotherapy
Vaginal Brachytherapy 1RADIATION

5 Gy, 3 times

Adjuvant Radiotherapy
Vaginal brachytherapy 2RADIATION

5 Gy, 2-4 times

Adjuvant Radiotherapy

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Qilu Hospital，Shandong University

Jinan, Shandong, 250012, China

Location

Women's Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310006, China

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

PaclitaxelCarboplatin

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination Complexes

Study Officials

  • Beihua Kong, MD, PhD

    Qilu Hospital of Shandong University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of the department of Obstetrics and Gynecology, Tongji Hospital

Study Record Dates

First Submitted

March 20, 2013

First Posted

March 29, 2013

Study Start

November 1, 2012

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

April 2, 2024

Record last verified: 2024-04

Locations

CN(3)