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

Phase

Condition

Endometrial Cancer

Pelvic Cancer

Endometriosis

Treatment

N/A

Clinical Study ID

NCT00376844

CDR0000502033

ISRCTN16228756

CKTO-2001-04

P01.146

Ages > 18
Female

Study 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.

Eligibility Criteria

Inclusion

INCLUSION CRITERIA:

Diagnosis of FIGO 1988 stage I-IIA endometrial cancer, meeting 1 of the followingcriteria:
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 torandomisation
WHO performance status 0-2

Exclusion

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

Study Design

May 01, 2002

April 30, 2016

Study 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.

Connect with a study center

Leiden University Medical Center
Leiden, 2300 RC
Netherlands
Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.