Condition category
Cancer
Date applied
06/04/2000
Date assigned
06/04/2000
Last edited
12/01/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ctu.mrc.ac.uk/studies/ASTEC.asp

Contact information

Type

Scientific

Primary contact

Ms Claire Amos

ORCID ID

Contact details

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00003749

Protocol/serial number

UT01

Study information

Scientific title

Acronym

ASTEC

Study hypothesis

1. To determine the benefit or otherwise of lymphadenectomy in patients with endometrial cancer (thought pre-operatively to be confined to the corpus).
2. To determine the benefit or otherwise of post-operative adjuvant radiotherapy in patients with endometrial cancer, high risk pathology and no macroscopic disease following surgery

Ethics approval

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Cancer

Intervention

There are four groups:
1. The first group receives standard surgery alone.
2. The second group receives standard surgery plus lymphadenectomy
3. The third group receives standard surgery plus (external beam) radiotherapy
4. The fourth group receives standard surgery plus lymphadenectomy plus (external beam) radiotherapy.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Primary endpoint is survival.

Secondary outcome measures

Secondary endpoints are recurrence-free survival and quality of life.

Overall trial start date

01/04/1998

Overall trial end date

01/01/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Surgical randomisation inclusion:
1. Histologically proven diagnosis of endometrial carcinoma
2. Disease thought pre-operatively to be confined to the corpus (CT or MRI scanning suggesting node enlargement is not an exclusion to randomisation and should not influence the decision to randomise)
3. Patient fit to undergo lymphadenectomy
4. Centre able to offer appropriate surgery
5. Patient fit to receive external beam radiotherapy
6. Written informed consent (for randomisation into both surgical and radiotherapy components).

Radiotherapy randomisation inclusion:
1. Histologically proven diagnosis of endometrial carcinoma
2. Disease pre-operatively confined to the corpus
3. Macroscopically free of disease (positive para-aortic nodes should be viewed as indicative of further [unseen] macroscopic disease)
4. Fit to receive external beam radiotherapy
5. High risk pathology, assessed independently of nodal status, defined as one or more of the following: Grade 3 (poorly differentiated) or Invasion to the outer half of the myometrium or Serous papillary or clear cell type or Stage IIA
6. Written informed consent.

Participant type

Patient

Age group

Not Specified

Gender

Female

Target number of participants

2,300

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/04/1998

Recruitment end date

01/01/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19070889
2008 pooled trial results, systematic review and meta-analysis of STEC and NCIC CTG EN.5 trials: http://www.ncbi.nlm.nih.gov/pubmed/19070891

Publication citations

  1. , 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, 373, 9658, 125-136, doi: 10.1016/S0140-6736(08)61766-3.

  2. , 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, 373, 9658, 137-146, doi: 10.1016/S0140-6736(08)61767-5.

Additional files

Editorial Notes