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

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ClinicalTrials.gov Identifier: NCT00376844
Recruitment Status : Completed
First Posted : September 15, 2006
Last Update Posted : February 27, 2018
Sponsor:
Collaborator:
Dutch Cancer Society
Information provided by (Responsible Party):
Carien Creutzberg, Leiden University Medical Center

Tracking Information
First Submitted Date  ICMJE September 13, 2006
First Posted Date  ICMJE September 15, 2006
Last Update Posted Date February 27, 2018
Study Start Date  ICMJE May 2002
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2018)
Vaginal relapse [ Time Frame: 5 years ]
total vaginal relapse and vaginal relapse as first failure
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2018)
  • Rate of distant metastases [ Time Frame: 5 years ]
    total distant relapse and distant relapse as first failure
  • Overall survival [ Time Frame: 5 years ]
    all-cause survival (and cancer-related survival)
  • Adverse effects [ Time Frame: 5 years ]
    Types and severity graded according to EORTC-RTOG grading system
  • Health-related quality of life [ Time Frame: 5 years ]
    Cancer-specific quality of life (EORTC QLQ C-30); patient reported symptoms
  • Pelvic relapse [ Time Frame: 5 years ]
    total pelvic relapse and pelvic relapse as first failure
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE External-Beam Radiation Therapy Compared With Vaginal Brachytherapy After Surgery for Stage I Endometrial Cancer
Official Title  ICMJE PORTEC-2, Postoperative Radiation Therapy for Endometrial Carcinoma - A Multicenter Randomised Phase III Trial Comparing External Beam Radiation and Vaginal Brachytherapy
Brief Summary

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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Exterbal beam radiation therapy versus vaginal brachytherapy
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Endometrial Cancer
Intervention  ICMJE
  • Radiation: External Beam Radiation Therapy
    Other Name: pelvic radiotherapy
  • Radiation: Vaginal Brachytherapy
    Other Name: internal radiation
Study Arms  ICMJE
  • Active Comparator: External Beam Radiation Therapy
    Postoperative pelvic radiotherapy
    Intervention: Radiation: External Beam Radiation Therapy
  • Experimental: Vaginal Brachytherapy
    Postoperative vaginal brachytherapy
    Intervention: Radiation: Vaginal Brachytherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2016)
427
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

INCLUSION CRITERIA:

  • Diagnosis of FIGO 1988 stage I-IIA endometrial cancer, meeting 1 of the following criteria:

    • Age ≥60, stage IC grade 1 or 2 with deep (≥ 50%) myometrial invasion
    • Age ≥60, stage IB grade 2 or 3 (with < 50% myometrial invasion)
    • Stage IIA, any age
  • No grade 3 endometrial carcinoma with deep myometrial invasion
  • Total abdominal hysterectomy and bilateral salpingo-oophorectomy required prior to randomisation
  • WHO performance status 0-2

EXCLUSION CRITERIA:

  • Serous or clear cell histology or uterine sarcoma
  • staging lymphadenectomy
  • interval between surgery and radiotherapy > 8 weeks
  • history of previous malignant disease (except basal cell carcinoma of skin)
  • previous radiotherapy, hormonal therapy or chemotherapy
  • diagnosis of Chrohn's disease or ulcerative colitis
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00376844
Other Study ID Numbers  ICMJE CDR0000502033
CKTO-2001-04 ( Other Grant/Funding Number: Dutch Cancer Society )
P01.146 ( Other Identifier: LUMC Ethics Committee )
ISRCTN16228756 ( Registry Identifier: ISRCTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Will be decided late 2016
Responsible Party Carien Creutzberg, Leiden University Medical Center
Study Sponsor  ICMJE Leiden University Medical Center
Collaborators  ICMJE Dutch Cancer Society
Investigators  ICMJE
Study Chair: Carien L. Creutzberg, MD, PhD Leiden University Medical Center
PRS Account Leiden University Medical Center
Verification Date February 2018

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