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External-Beam Radiation Therapy Compared With Vaginal Brachytherapy After Surgery for Stage I Endometrial Cancer (PORTEC-2)

This study has been completed.
Sponsor:
Collaborator:
Dutch Cancer Society
Information provided by (Responsible Party):
Carien Creutzberg, Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT00376844
First received: September 13, 2006
Last updated: April 24, 2016
Last verified: April 2016
  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
Radiation: External Beam Radiation Therapy
Radiation: Vaginal Brachytherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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

Further study details as provided by Leiden University Medical Center:

Primary Outcome Measures:
  • Rate of vaginal relapse [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of distant metastases [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Adverse effects [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • health-related quality of life [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Pelvic relapse [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 427
Study Start Date: May 2002
Study Completion Date: April 2016
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: External Beam Radiation Therapy
Postoperative pelvic radiotherapy
Radiation: External Beam Radiation Therapy
Other Name: pelvic radiotherapy
Experimental: Vaginal Brachytherapy
Postoperative vaginal brachytherapy
Radiation: Vaginal Brachytherapy
Other Name: internal radiation

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 400 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   up to 120 Years   (Child, Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376844

Locations
Netherlands
Leiden University Medical Center
Leiden, Netherlands, 2300 RC
Sponsors and Collaborators
Leiden University Medical Center
Dutch Cancer Society
Investigators
Study Chair: Carien L. Creutzberg, MD, PhD Leiden University Medical Center
  More Information

Publications:
Nout RA, Putter H, Jürgenliemk-Schulz IM, et al.: Vaginal brachytherapy versus external beam pelvic radiotherapy for high-intermediate risk endometrial cancer: Results of the randomized PORTEC-2 trial. [Abstract] J Clin Oncol 26 (Suppl 15): A-LBA5503, 2008.

Responsible Party: Carien Creutzberg, Professor of Radiation Oncology, Chief investigator, Leiden University Medical Center
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: April 24, 2016
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description: Will be decided late 2016

Keywords provided by Leiden University Medical Center:
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 December 08, 2016