A randomised trial of lymphadenectomy and of adjuvant external beam radiotherapy in endometrial cancer

ISRCTN	ISRCTN16571884
DOI	https://doi.org/10.1186/ISRCTN16571884
ClinicalTrials.gov number	NCT00003749
Secondary identifying numbers	UT01

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Ms Claire Amos
Scientific

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	A randomised trial of lymphadenectomy and of adjuvant external beam radiotherapy in endometrial cancer
Study acronym	ASTEC
Study objectives	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(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	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
Primary outcome measure	Primary endpoint is survival.
Secondary outcome measures	Secondary endpoints are recurrence-free survival and quality of life.
Overall study start date	01/04/1998
Completion date	01/01/2005

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Target number of participants	2,300
Key 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.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/04/1998
Date of final enrolment	01/01/2005

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone	+44 (0)20 7636 5422
Email	clinical.trial@headoffice.mrc.ac.uk
Website	http://www.mrc.ac.uk

Research council

Medical Research Council (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Plain English results			No	Yes
Results article	pooled trial results, systematic review and meta-analysis of STEC and NCIC CTG EN.5 trials:	10/01/2009	Yes	No
Results article	results	10/01/2009	Yes	No

22/10/2018: Cancer Research UK lay results summary link added to Results (plain English)