MedTrace Logo

Randomized Trial of Radiation Therapy With or Without Chemotherapy for Endometrial Cancer

NCT00411138 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 670

Last updated 2023-10-11

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving chemotherapy together with radiation therapy is more effective than giving radiation therapy alone in treating endometrial cancer.

PURPOSE: This randomized phase III trial is studying chemotherapy and radiation therapy to see how well they work compared with radiation therapy alone in treating patients with high-risk, stage I, stage II, or stage III endometrial cancer.

Conditions

Interventions

RADIATION

Radiation Therapy

External beam pelvic radiotherapy (48.6 Gy in 1.8 Gy fractions) Vaginal brachytherapy boost in case of cervical involvement

DRUG

cisplatin

cisplatin 50 mg/m2 i.v., 2 cycles during radiotherapy, 3 wks interval

DRUG

carboplatin

carboplatin AUC 5, 4 cycles after completion of radiotherapy, 3 wks interval

DRUG

Paclitaxel

paclitaxel 175 mg/m2, 4 cycles after completion of radiotherapy, 3 wks interval

Sponsors & Collaborators

  • Cancer Research UK

    collaborator OTHER

  • Australia New Zealand Gynaecological Oncology Group

    collaborator OTHER

  • NCIC Clinical Trials Group

    collaborator NETWORK

  • Mario Negri Institute for Pharmacological Research

    collaborator OTHER

  • UNICANCER

    collaborator OTHER

  • Leiden University

    lead OTHER

Principal Investigators

  • Carien L. Creutzberg, MD, PhD · Leiden University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-23
Primary Completion
2018-11-29
Completion
2024-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT00411138 on ClinicalTrials.gov