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


Phase 3
N/A
N/A
Open (Enrolling)
Female
Endometrial Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Rate of locoregional relapse at 5 years

Safety Issue:

No

Principal Investigator

Carien C. L. Creutzberg, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Leiden University Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000502033

NCT ID:

NCT00376844

Start Date:

May 2006

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • stage I endometrial carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

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