A multicentre, phase III, randomised, double-blind, placebo-controlled trial of pravastatin added to first-line chemotherapy in patients with small cell lung cancer
| ISRCTN | ISRCTN56306957 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56306957 |
| EudraCT/CTIS number | 2005-005821-71 |
| ClinicalTrials.gov number | NCT00433498 |
| Secondary identifying numbers | BRD/05/129 |
- Submission date
- 07/04/2006
- Registration date
- 08/05/2006
- Last edited
- 25/10/2022
- 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
Contact information
Prof Michael Seckl
Scientific
Scientific
Department of Medical Oncology
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
Study information
| Study design | Multicentre phase III randomised double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A multicentre, phase III, randomised, double-blind, placebo-controlled trial of pravastatin added to first-line chemotherapy in patients with small cell lung cancer |
| Study acronym | LungStar |
| Study objectives | To see if the addition of pravastatin to standard combination chemotherapy (cisplatin and etoposide or carboplatin and etoposide) improves response rates, time to disease progression, and survival in patients with Small Cell Lung Cancer (SCLC). On 15/02/2011 the following changes were made to the trial record: 1. The anticipated end date was changed from 30/04/2010 to 31/10/2011. 2. The target number of participants was changed from 1300 to 860. |
| Ethics approval(s) | Multicentre Research Ethics Committee for Scotland, 19/04/2006, ref: 06/MRE10/28 |
| Health condition(s) or problem(s) studied | Small cell lung cancer |
| Intervention | All patients receive standard chemotherapy: Cisplatin/Etoposide or Carboplatin/Etoposide. They are then randomised prior to or within one working day of starting chemotherapy to: 1. Pravastatin daily for two years 2. Placebo daily for two years Assessments with each cycle of chemotherapy then, follow up post chemotherapy, two monthly to one year from randomisation then three monthly thereafter. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Pravastatin, cisplatin, carboplatin, etoposide |
| Primary outcome measure | To determine in patients with SCLC if survival is affected by the addition of pravastatin to either cisplatin/etoposide or carboplatin/etoposide |
| Secondary outcome measures | To compare the treatments in terms of: 1. Progression-free survival 2. Local progression-free survival (local control) 3. Response rates 4. Toxicity |
| Overall study start date | 01/06/2006 |
| Completion date | 31/10/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 860 |
| Key inclusion criteria | 1. Histologically or cytologically confirmed SCLC 2. Limited or extensive disease 3. Performance status Eastern Cooperative Oncology Group (ECOG) zero to three 4. Life expectancy more than 8 weeks 5. Age 18 or over 6. Willing and able to give informed consent 7. Patient considered able to tolerate chemotherapy 8. Adequate renal function - defined by glomerular filtration rate (GFR) more than 50 ml/min if measured by EthyleneDiamineTetraacetic Acid (EDTA) or GFR more than 40 ml/min if measured by the Cockcroft and Gault (C & G) formula. Cisplatin and etoposide dose should be modified according to renal function as per dose modification schedule. 9. Adequate bone marrow reserve - Absolute Neutrophil Count (ANC) more than 1.5 x 10^9 /l, Haemoglobin (Hb) more than 10.0 g/dl and platelet count more than 100 x 10^9 /l 10. Liver function tests less than three times Upper Limit of Normal (ULN) 11. Creatine Kinase less than or equal to five times ULN |
| Key exclusion criteria | 1. Prior chemotherapy for this disease (protocol chemotherapy should start after randomisation except for where a patient needs to start chemotherapy urgently, randomisation may occur a maximum of one working day after day one of cycle one) 2. Prior radiotherapy for this disease (except for prior radiotherapy to distant metastases i.e. not within the thorax or thoracic or cervical spine is acceptable) 3. Evidence of significant medical condition or laboratory finding which, in the opinion of the investigator, makes it undesirable for the patient to participate in the trial 4. Patients with a family history of hypercholesterolaemia 5. A history of prior malignant tumour, unless the patient has been without evidence of disease for at least three years or the tumour was a non-melanoma skin tumour or early cervical cancer 6. Patients treated with fibrates e.g. bezofibrate, gemfibrozil, fenofibrate within four weeks prior to randomisation 7. Patients on cyclosporin 8. Patients with symptomatic brain metastases, which require immediate radiotherapy 9. Pregnancy and lactation. Effective contraception is mandatory for all patients of reproductive potential if sexually active whilst in the study. Contraception should continue for one year post-completion of all chemotherapy or radiotherapy and a further 28 days after cessation of pravastatin or placebo 10. Treatment with any statin within previous 12 months |
| Date of first enrolment | 01/06/2006 |
| Date of final enrolment | 31/10/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Medical Oncology
London
W6 8RF
United Kingdom
W6 8RF
United Kingdom
Sponsor information
University College London (UK)
University/education
University/education
Gower Street
London
WC1E 6BT
England
United Kingdom
| Website | http://www.ucl.ac.uk |
|---|---|
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK) (ref: C1312/A5335)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- 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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Results article | results | 10/05/2017 | Yes | No | |
| Plain English results | 25/10/2022 | No | Yes |
Editorial Notes
25/10/2022: Cancer Research UK plain English results link added.
19/03/2020: EudraCT number added. Added EudraCT link to basic results (scientific).
16/03/2017: Publication reference added
