Surgery With or Without Lymphadenectomy and Radiation Therapy in Treating Patients With Endometrial Cancer

Phase 3

Completed

• Conditions: Endometrial Cancer

• Registration Number: NCT00003749
• Lead Sponsor: Medical Research Council

Brief Summary

RATIONALE: Lymphadenectomy may remove cancer cells that have spread to nearby lymph nodes. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether conventional surgery is more effective with or without lymphadenectomy and/or radiation therapy in treating endometrial cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of conventional surgery with or without lymphadenectomy and/or radiation therapy in treating patients who have endometrial cancer.

Detailed Description

OBJECTIVES:

* Compare the effects of conventional surgery alone and conventional surgery plus lymphadenectomy in patients with endometrial cancer preoperatively thought to be confined to the uterine corpus.

* Determine the effect of postoperative adjuvant external beam radiotherapy on quality of life and survival of a subset of these patients at high risk of relapse and with no macroscopic disease after surgery.

OUTLINE: This is a randomized, multicenter study. Patients are randomized in both the surgery and radiotherapy segments of the study.

* Surgery: Patients are randomized to 1 of 2 surgery arms.

* Arm I: Patients undergo conventional surgery (total abdominal hysterectomy and bilateral salpingo-oophorectomy).

* Arm II: Patients undergo conventional surgery as in arm I followed by lymphadenectomy with systematic dissection of the iliac and obturator nodes.

* Radiotherapy: Patients at high risk of relapse who have no postoperative macroscopic disease are randomized to 1 of 2 radiotherapy arms. (Patients may enter the radiotherapy randomization after surgery off study.)

* Arm I: Patients receive in 20-25 fractions of external beam radiotherapy (total dose of 40-46 Gy) over 4-5 weeks.

* Arm II: Patients receive no external beam radiotherapy. NOTE: Some patients receive vault brachytherapy regardless of radiotherapy randomization.

Quality of life is assessed before therapy and at 2 and 5 years after therapy.

Patients are followed every 3 months for 1 year and then every 6 months for 1 year.

PROJECTED ACCRUAL: A minimum of 1400 patients will be accrued for the surgical component of this study and at least 900 patients (including additional patients not participating in the surgical component of this study) will be accrued for the radiotherapy component of this study.

Study Timeline

• Study Start: 1998-04
• Status Verified: 1999-04
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Study Completion: 2008-12
• Last Update Submitted: 2013-12-18
• Last Update Posted: 2013-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (3)

Medical Research Council Clinical Trials Unit; 🇬🇧 London, England, United Kingdom

Royal Marsden NHS FoundationTrust - London; 🇬🇧 London, England, United Kingdom

St. Mary's Hospital; 🇬🇧 Manchester, England, United Kingdom