Post-Operative Radiotherapy for Non-Small Cell Lung Cancer
| ISRCTN | ISRCTN46536242 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46536242 |
| Protocol serial number | LU11 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 15/11/2019
- 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
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Post-Operative Radiotherapy for Non-Small Cell Lung Cancer |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Lung (non-small cell) cancer |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration. |
| Key secondary outcome measure(s) |
Not provided at time of registration. |
| Completion date | 31/12/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 308 |
| Total final enrolment | 308 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 31/12/2002 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/1996 | 15/11/2019 | Yes | No |
Editorial Notes
15/11/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
19/01/2016: No publications found on PubMed.
