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

September 13, 2006
September 16, 2013
May 2006
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  • 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 ]
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Complete list of historical versions of study NCT00376844 on ClinicalTrials.gov Archive Site
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External-Beam Radiation Therapy or Implant Radiation Therapy Compared With Observation in Treating Patients Who Have Undergone Surgery for Stage I Endometrial Cancer
PORTEC-2, Postoperative Radiation Therapy for Endometrial Carcinoma - A Multicenter Randomised Phase III Trial Comparing External Beam Radiation and Vaginal Brachytherapy

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.

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.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Endometrial Cancer
  • Other: clinical observation
  • Procedure: adjuvant therapy
  • Radiation: brachytherapy
  • Radiation: radiation therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
104
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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
Female
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No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00376844
CDR0000502033, CKTO-2001-04, EU-20508
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Commissie Voor Klinisch Toegepast Onderzoek
Not Provided
Study Chair: Carien C. L. Creutzberg, MD, PhD Leiden University Medical Center
National Cancer Institute (NCI)
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP