Plain English Summary
Not provided at time of registration
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00003749
Protocol/serial number
UT01
Study information
Scientific title
A randomised trial of lymphadenectomy and of adjuvant external beam radiotherapy in endometrial cancer
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 measure
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 (if study stopped)
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 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
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
Basic results (scientific)
Publication list
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
-
, 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.
-
, 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.