A randomised controlled dose intensification clinical trial of chemotherapy with or without recombinant human granulocyte colony stimulating factor (G-CSF) in small cell lung cancer (SCLC)
| ISRCTN | ISRCTN15921116 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15921116 |
| Secondary identifying numbers | LU19 |
- Submission date
- 13/03/2001
- Registration date
- 13/03/2001
- Last edited
- 19/09/2017
- 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 Danielle Andrews
Scientific
Scientific
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | A randomised controlled dose intensification clinical trial of chemotherapy with or without recombinant human granulocyte colony stimulating factor (G-CSF) in small cell lung cancer (SCLC) |
| Study objectives | The aim of the trial is to investigate in patients with limited or extensive SCLC and good performance status, whether the addition of haemopoeitic growth factor (G-CSF) to chemotherapy: 1. Improves survival 2. Permits shortening of the interval between cycles 3. Reduces toxic myelosuppression 4. Affects the quality of life during the first 6 months from randomisation |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Lung cancer |
| Intervention | The trial is designed to determine whether dose intensification with G-CSF is associated with a significant improvement in outcome compared with SCLC patients not receiving G-CSF. Patients with limited or extensive SCLC and a performance status of WHO 0-2 are randomised to receive ACE chemotherapy with or without G-CSF. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Haemopoeitic growth factor (G-CSF) |
| Primary outcome measure | Principle end-point is survival from randomisation |
| Secondary outcome measures | Secondary end-points are: 1. Interval between cycles of chemotherapy 2. Clinical septicaemic myelosuppression 3. WHO grade 3 or 4 neutropenia (less than 1000/mm3 cubed) 2 weeks after the first 3 cycles of chemotherapy 4. Quality of life 5. Days spent in hospital |
| Overall study start date | 01/12/1993 |
| Completion date | 01/03/1996 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 400 |
| Key inclusion criteria | 1. Untreated, microscopically proven SCLC 2. World Health Organisation (WHO) performance status 0-2 3. Alkaline phosphatase (AP) and Alanine amino transferase (ALT) less than or equal to 2.5 x upper normal limit and serum creatine/urea less than or equal to 1.25 x upper normal limit 4. Not receiving any other investigational drugs 5. Female patients must not be pregnant |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/12/1993 |
| Date of final enrolment | 01/03/1996 |
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 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (MRC) (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 | |
|---|---|
| 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? |
|---|---|---|---|---|---|
| Other publications | Analysis of messy longitudinal data from a randomized clinical trial. MRC Lung Cancer Working Party () | 15/10/2000 | Yes | No | |
| Results article | Cost effectiveness results | 01/10/2006 | Yes | No |
Editorial Notes
19/09/2017: Publication reference added.
