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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 1999 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00003749

First received: November 1, 1999

Last updated: June 21, 2011

Last verified: April 1999

History of Changes

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

June 21, 2011

Start Date ^ICMJE

April 1998

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00003749 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Primary Purpose: Treatment

Condition ^ICMJE

Endometrial Cancer

Intervention ^ICMJE

Procedure: adjuvant therapy
Procedure: conventional surgery
Radiation: brachytherapy
Radiation: radiation therapy

Study Arm (s)

Not Provided

Publications *

Kitchener HC: The effect of incision in the surgical treatment of endometrial cancer and long-term follow-up of a randomized trial of lymphadenectomy: results of the MRC ASTEC trial. [Abstract] J Clin Oncol 29 (Suppl 15): A-e15583, 2011.
ASTEC study group; Kitchener H, Swart AM, Qian Q, Amos C, Parmar MK. Efficacy of systematic pelvic lymphadenectomy in endometrial cancer (MRC ASTEC trial): a randomised study. Lancet. 2009 Jan 10;373(9658):125-36. Epub 2008 Dec 16.
Barton DP, Naik R, Herod J. Efficacy of systematic pelvic lymphadenectomy in endometrial cancer (MRC ASTEC Trial): a randomized study. Int J Gynecol Cancer. 2009 Nov;19(8):1465. No abstract available.
The ASTEC/EN.5 writing committee on behalf of the ASTEC/EN.5 Study Group. Adjuvant external beam radiotherapy in the treatment of endometrial cancer (MRC ASTEC and NCIC CTG EN.5 randomised trials): pooled trial results, systematic review, and meta-analysis. Lancet. 2008 Dec 12; [Epub ahead of print]

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

2300

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00003749

Other Study ID Numbers ^ICMJE

CDR0000066869, MRC-ASTEC, EU-98062

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Medical Research Council

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Investigator:

Claire Amos

Medical Research Council

Information Provided By

National Cancer Institute (NCI)

Verification Date

April 1999

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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