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

Sponsor

Medical Research Council (Other)

Overall Status

Completed

CT.gov ID

NCT00003749

Collaborator

(none)

2,300

Enrollment

Locations

128

Duration (Months)

766.7

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Cancer	Procedure: adjuvant therapy Procedure: conventional surgery Radiation: brachytherapy Radiation: radiation therapy	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

2300 participants

Allocation:

Randomized

Primary Purpose:

Treatment

Official Title:

A Randomised Trial of Lymphadenectomy and of Adjuvant External Beam Radiotherapy in the Treatment of Endometrial Cancer

Study Start Date :

Apr 1, 1998

Actual Study Completion Date :

Dec 1, 2008

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Surgical randomization:

Histologically confirmed endometrial carcinoma
Disease thought preoperatively to be confined to the uterine corpus

Radiotherapy randomization:

Must have disease determined postoperatively to be confined to the uterine corpus, irrespective of pelvic node status
No cervical stroma invasion (stage IIB)
Must be macroscopically free of disease (no positive para-aortic nodes)
Must have high-risk disease defined as one or more of the following:
Grade 3 (poorly differentiated)
Invasion to the outer half of the myometrium (stage IC)
Serous papillary or clear cell type
Stage IIA (endocervical glandular involvement)

PATIENT CHARACTERISTICS:

Age:

Any age

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

Other:

No other prior or concurrent malignancy likely to interfere with protocol treatment or comparisons
Surgical randomization:
Must be fit to undergo lymphadenectomy and external beam radiotherapy
Radiotherapy randomizations:
Must be fit to receive external beam radiotherapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

Not specified

Endocrine therapy:

Not specified

Radiotherapy:

Not specified

Surgery:

Not specified

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Research Council Clinical Trials Unit	London	England	United Kingdom	NW1 2DA
2	Royal Marsden NHS FoundationTrust - London	London	England	United Kingdom	SW3 6JJ
3	St. Mary's Hospital	Manchester	England	United Kingdom	M13 0JH