Medical Research Council fourth non-small cell lung cancer radiotherapy study: clinical trial of radiotherapy for good-performance-status patients with inoperable non-small cell lung cancer too large in volume for radical radiotherapy
| ISRCTN | ISRCTN53968814 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53968814 |
| Protocol serial number | LU13 |
| 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 | Medical Research Council fourth non-small cell lung cancer radiotherapy study: clinical trial of radiotherapy for good-performance-status patients with inoperable non-small cell lung cancer too large in volume for radical radiotherapy |
| 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 | 1. Radiotherapy Regimen A: A total dose of 17 Gy given as two fractions of 8.5 Gy with an interval of one week between the fractions. 2. Radiotherapy Regimen B: A total dose of 39 Gy given as thirteen fractions of 3 Gy during three weeks in daily fractions five days per week. Radiotherapy should start within two weeks of randomisation. If the patient has superior vena cava obstruction, a course of steroids may be given during the period of radiotherapy. |
| 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 | Other |
| Sex | All |
| Key inclusion criteria | 1. Primarily untreated, microscopically confirmed non-small cell lung cancer 2. Performance status World Health Organisation (WHO) grade zero to two 3. Disease too advanced for radical radiotherapy 4. Either sex, any age |
| Key exclusion criteria | 1. Previous surgery, radiotherapy or chemotherapy for non-small cell lung cancer 2. Other previous concomitant malignant disease. Except previous basal cell carcinoma or in situ carcinoma of the cervix 3. Evidence of distant metastases outside of the locoregional volume |
| 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 | 01/10/1994 | 15/11/2019 | Yes | No |
Editorial Notes
15/11/2019: Publication reference added.
