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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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10 December 2019 |
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Main ID: |
ISRCTN46536242 |
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Date of registration:
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19/08/2002 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Post-Operative Radiotherapy for Non-Small Cell Lung Cancer
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Scientific title:
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Post-Operative Radiotherapy for Non-Small Cell Lung Cancer |
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Date of first enrolment:
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01/01/2002 |
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Target sample size:
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308 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN46536242 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Not Specified)
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Phase:
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Not Specified
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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-
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Address:
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
NW1 2DA
London
United Kingdom |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Either sex, aged 75 years or less
2. World Health Organisation (WHO) performance status zero to two
3. Lung and cardiac function adequate for proposed resection
4. pT1 pN1 M0, pT2 pN1 M0, pT1 pN2 M0 or pT2 pN2 M0 non-small cell lung cancer
5. Complete resection of non-small cell lung cancer
Exclusion criteria:
1. Previous specific anti-cancer treatment for current disease
2. Presence of other malignant disease, except basal cell carcinoma or in situ carcinoma of the cervix
3. Presence of other serious condition contraindicating surgery or radiotherapy
Age minimum:
Age maximum:
Gender:
Not Specified
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Health Condition(s) or Problem(s) studied
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Lung (non-small cell) cancer
Cancer
Malignant neoplasm of bronchus or lung
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Intervention(s)
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Patients are randomised two to four weeks postoperatively to either:
1. Schedule R: Radiotherapy 40 Gy given in daily fractions five days a week over three weeks to mediastinum starting four to six weeks post-operatively.
2. Schedule NoR: No further specific treatment including post-operative radiotherapy unless or until the disease recurrence.
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Primary Outcome(s)
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Not provided at time of registration.
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Secondary Outcome(s)
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Not provided at time of registration.
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Source(s) of Monetary Support
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Medical Research Council (MRC) (UK)
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Ethics review
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Status:
Approval date:
Contact:
Not provided at time of registration
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/12/2002 |
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URL:
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