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Chemotherapy or Observation in Stage I-II Intermediate or High Risk Endometrial Cancer

NCT01244789 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2026-04-13

No results posted yet for this study

Summary

Patients with stage 1 \& 2 endometrial cancer are treated with surgery. Despite the fact that disease is confound to uterus, unfortunately some of these patients may relapse and die of their disease. Postoperative radiotherapy cannot improve survival. Chemotherapy has shown survival benefit in more advanced stage disease (stage 3 \& 4).

This study evaluates if one can improve survival in intermediate and high risk early-stage patients by offering them postoperative chemotherapy. This is a randomized phase 3 trial where effect of postoperative chemotherapy is compared with postoperative observation alone (standard strategy).

Substudy: Translational research

Conditions

Interventions

DRUG

carboplatin and paclitaxel

6 courses of iv 3-weekly chemotherapy Carboplatin AUC5 Paclitaxel 175mg/m2

OTHER

observation

active observation

Sponsors & Collaborators

  • European Organisation for Research and Treatment of Cancer - EORTC

    collaborator NETWORK

  • Arbeitsgemeinschaft Gynaekologische Onkologie Austria

    collaborator OTHER

  • North Eastern German Society of Gynaecological Oncology

    collaborator OTHER

  • Nordic Society of Gynaecological Oncology - Clinical Trials Unit

    collaborator OTHER

  • Belgian Gynaecological Oncology Group

    collaborator OTHER

  • Mario Negri Gynecologic Oncology group (MaNGO)

    collaborator OTHER

  • Israeli Society of Gynecologic Oncology

    collaborator OTHER

  • Multicenter Italian Trials in Ovarian cancer and gynecologic malignancies (MITO)

    collaborator UNKNOWN

  • Central and Eastern European Oncology Group

    collaborator OTHER

  • Danish Gynecological Cancer Group

    lead NETWORK

Principal Investigators

  • Kristine Madsen, MD · Danish Gynecological Cancer Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2028-07-01
Completion
2028-07-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01244789 on ClinicalTrials.gov