NCT00003749

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,300

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 1998

Longer than P75 for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1998

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
5.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

December 19, 2013

Status Verified

April 1, 1999

First QC Date

November 1, 1999

Last Update Submit

December 18, 2013

Conditions

Endometrial Cancer

Keywords

stage I endometrial carcinomastage II endometrial carcinomaendometrial clear cell carcinomaendometrial papillary serous carcinoma

Interventions

adjuvant therapyPROCEDURE
conventional surgeryPROCEDURE
brachytherapyRADIATION
radiation therapyRADIATION

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Medical Research Council Clinical Trials Unit

London, England, NW1 2DA, United Kingdom

Location

Royal Marsden NHS FoundationTrust - London

London, England, SW3 6JJ, United Kingdom

Location

St. Mary's Hospital

Manchester, England, M13 0JH, United Kingdom

Location

Related Publications (4)

  • ASTEC/EN.5 Study Group; Blake P, Swart AM, Orton J, Kitchener H, Whelan T, Lukka H, Eisenhauer E, Bacon M, Tu D, Parmar MK, Amos C, Murray C, Qian W. 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. 2009 Jan 10;373(9658):137-46. doi: 10.1016/S0140-6736(08)61767-5. Epub 2008 Dec 16.

    PMID: 19070891BACKGROUND

  • 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.

    RESULT

  • 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. doi: 10.1016/S0140-6736(08)61766-3. Epub 2008 Dec 16.

    PMID: 19070889RESULT

  • 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. doi: 10.1111/IGC.0b013e3181b89f95. No abstract available.

    PMID: 19893425RESULT

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Chemotherapy, AdjuvantBrachytherapyRadiotherapy

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Claire Amos

    Medical Research Council

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

April 1, 1998

Study Completion

December 1, 2008

Last Updated

December 19, 2013

Record last verified: 1999-04

Locations

GB(3)