A randomised trial of lymphadenectomy and of adjuvant external beam radiotherapy in endometrial cancer
ISRCTN | ISRCTN16571884 |
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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
Contact information
Ms Claire Amos
Scientific
Scientific
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
Study design | Randomised controlled trial |
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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 |
Eligibility
Participant type(s) | Patient |
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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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
Phone | +44 (0)20 7636 5422 |
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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
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 | |
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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 |
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)