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NCT Number: NCT00376844

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

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.

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Key information

Conditions

Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Leiden University Medical Center

Leiden, 2300 RC, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

external beam radiation therapy

Radiation

Other names: pelvic radiotherapy

Vaginal brachytherapy

Radiation

Other names: internal radiation

Primary outcomes

  1. Vaginal relapse

    Time frame: 5 years

    total vaginal relapse and vaginal relapse as first failure

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Leiden University

Other

Collaborators

  • Dutch Cancer Society

Registry information

Official study title

PORTEC-2, Postoperative Radiation Therapy for Endometrial Carcinoma - A Multicenter Randomised Phase III Trial Comparing External Beam Radiation and Vaginal Brachytherapy

Acronym: PORTEC-2

Important dates

Study start
2002
Primary completion
2009
Study completion
2016
First posted
Sep 15, 2006
Registry last updated
Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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