External-Beam Radiation Therapy or Implant Radiation Therapy Compared With Observation in Treating Patients Who Have Undergone Surgery for Stage I Endometrial Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00376844
First received: September 13, 2006
Last updated: September 16, 2013
Last verified: December 2011
  Purpose

RATIONALE: External-beam radiation therapy uses high-energy x-rays to kill tumor cells. Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving external-beam radiation therapy or implant radiation therapy after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether radiation therapy is more effective than observation when given after surgery in treating stage I endometrial cancer.

PURPOSE: This randomized phase III trial is studying external-beam radiation therapy or implant radiation therapy to see how well they work compared with observation in treating patients who have undergone surgery for stage I endometrial cancer.


Condition Intervention Phase
Endometrial Cancer
Other: clinical observation
Procedure: adjuvant therapy
Radiation: brachytherapy
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: PORTEC-2, Postoperative Radiation Therapy for Endometrial Carcinoma - A Multicenter Randomised Phase III Trial Comparing External Beam Radiation and Vaginal Brachytherapy

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Rate of locoregional relapse at 5 years [ Designated as safety issue: No ]
  • Rate of distant metastases at 5 years [ Designated as safety issue: No ]
  • Overall survival rate [ Designated as safety issue: No ]
  • Prognostic factors for relapse and morbidity [ Designated as safety issue: No ]

Estimated Enrollment: 104
Study Start Date: May 2006
Detailed Description:

OBJECTIVES:

  • Compare the rate of 5-year locoregional relapse in patients undergoing external-beam radiotherapy or vaginal brachytherapy vs observation only after surgery for stage I endometrial cancer.
  • Compare 5-year rate of distant metastases in these patients.
  • Determine overall survival rate in these patients.
  • Determine prognostic factors for relapse and morbidity.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo either vaginal brachytherapy or external-beam radiotherapy.
  • Arm II: Patients are observed and undergo no further treatment. After completion of study treatment, patients are followed for approximately 83 days.

PROJECTED ACCRUAL: A total of 104 patients will be accrued for this study.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of stage I endometrial cancer meeting 1 of the following criteria:

    • Grade 1 or 2 with deep (≥ 50%) myometrial invasion (stage IC)
    • Grade 2 or 3 with superficial (< 50%) myometrial invasion (stage IB)
  • No grade 3 endometrial carcinoma with deep myometrial invasion
  • Total abdominal hysterectomy and bilateral salpingo-oophorectomy required prior to randomization

PATIENT CHARACTERISTICS:

  • Menopausal status not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00376844

Locations
Netherlands
Leiden University Medical Center
Leiden, Netherlands, 2300 RC
Sponsors and Collaborators
Commissie Voor Klinisch Toegepast Onderzoek
Investigators
Study Chair: Carien C. L. Creutzberg, MD, PhD Leiden University Medical Center
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00376844     History of Changes
Other Study ID Numbers: CDR0000502033, CKTO-2001-04, EU-20508
Study First Received: September 13, 2006
Last Updated: September 16, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I endometrial carcinoma

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 19, 2014