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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

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.


Condition or disease Intervention/treatment Phase
Endometrial Cancer Radiation: External Beam Radiation Therapy Radiation: Vaginal Brachytherapy Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 427 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Exterbal beam radiation therapy versus vaginal brachytherapy
Masking: None (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
Study Start Date : May 2002
Actual Primary Completion Date : May 2009
Actual Study Completion Date : April 2016

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Vaginal relapse [ Time Frame: 5 years ]
    total vaginal relapse and vaginal relapse as first failure


Secondary Outcome Measures :
  1. Rate of distant metastases [ Time Frame: 5 years ]
    total distant relapse and distant relapse as first failure

  2. Overall survival [ Time Frame: 5 years ]
    all-cause survival (and cancer-related survival)

  3. Adverse effects [ Time Frame: 5 years ]
    Types and severity graded according to EORTC-RTOG grading system

  4. Health-related quality of life [ Time Frame: 5 years ]
    Cancer-specific quality of life (EORTC QLQ C-30); patient reported symptoms

  5. Pelvic relapse [ Time Frame: 5 years ]
    total pelvic relapse and pelvic relapse as first failure



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications of Results:
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.

Other Publications:
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 ( Other Grant/Funding Number: Dutch Cancer Society )
P01.146 ( Other Identifier: LUMC Ethics Committee )
ISRCTN16228756 ( Registry Identifier: ISRCTN )
First Posted: September 15, 2006    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Will be decided late 2016

Keywords provided by Carien Creutzberg, 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