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
Submission date
06/04/2000
Registration date
06/04/2000
Last edited
22/10/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Ms Claire Amos
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleA randomised trial of lymphadenectomy and of adjuvant external beam radiotherapy in endometrial cancer
Study acronymASTEC
Study objectives1. 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) studiedCancer
InterventionThere 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 typeOther
Primary outcome measurePrimary endpoint is survival.
Secondary outcome measuresSecondary endpoints are recurrence-free survival and quality of life.
Overall study start date01/04/1998
Completion date01/01/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexFemale
Target number of participants2,300
Key inclusion criteriaSurgical 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 criteriaNot provided at time of registration
Date of first enrolment01/04/1998
Date of final enrolment01/01/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

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

Funders

Funder type

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

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added 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

Editorial Notes

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