A phase II/III randomised, double blind, placebo controlled trial of gemcitabine/carboplatin with or without thalidomide in advanced Non-Small Cell Lung Cancer (NSCLC)
| ISRCTN | ISRCTN77341241 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77341241 |
| Secondary identifying numbers | N/A |
- Submission date
- 02/07/2003
- Registration date
- 02/07/2003
- Last edited
- 29/10/2021
- 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
Dr Siow Ming Lee
Scientific
Scientific
Middlesex/UCL Hospitals
Meyerstein
Institute of Oncology
Mortimer Street
London
W1T 3AA
United Kingdom
| Phone | +44 (0)20 7380 9091 |
|---|---|
| sm.lee@uclh.org |
Study information
| Study design | Randomised placebo controlled parallel group 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 phase II/III randomised, double blind, placebo controlled trial of gemcitabine/carboplatin with or without thalidomide in advanced Non-Small Cell Lung Cancer (NSCLC) |
| Study acronym | LLCG Study 14 |
| Study objectives | Primary objective: To determine if survival is affected by the addition of thalidomide in patients with Non-Small Cell Lung Cancer (NSCLC) treated with gemcitabine/carboplatin. Secondary objective: To determine the effects of thalidomide on: 1. Time to disease progression 2. Toxicity 3. Response rate 4. Quality of life |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Non-small cell lung cancer |
| Intervention | Patients on the trial will receive up to 4 cycles of gemcitabine and carboplatin at 3 weekly intervals. Patients will be randomised to receive either thalidomide or placebo daily beginning on day 1 for up to 24 months. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II/III |
| Drug / device / biological / vaccine name(s) | Gemcitabine, carboplatin, thalidomide |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2003 |
| Completion date | 07/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 514 |
| Total final enrolment | 722 |
| Key inclusion criteria | 1. Histologically or cytologically confirmed NSCLC, stage IIIb or IV 2. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2 and estimated life expectancy of at least 8 weeks 3. Adequate renal function and bone marrow reserve 4. Women Of Childbearing Potential (WCBP) must agree to practice complete abstinence from heterosexual intercourse or to use TWO methods of contraception while on study medication, and have a negative serum or urine pregnancy test within the 24 hours before starting study medication. Those who are sexually active in a heterosexual relationship must agree to have pregnancy tests every 4 weeks while on study medication and 4 weeks after the last dose of study medication 5. Male patients (including those who have had a vasectomy) must use barrier contraception when engaging in heterosexual activity with WCBP while on study medication and 4 weeks after the last dose |
| Key exclusion criteria | 1. Pregnant or lactating women or WCBP not using adequate contraception 2. Prior treatment with chemotherapy or radiotherapy 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. Prior history of thromboembolic event (including: Pulmonary Embolism [PE], Deep Vein Thrombus [DVT], Cerebro-Vascular Accident [CVA]/Transient Ischaemic Attack [TIA]) 5. Symptomatic brain metastases thought to require immediate radiotherapy 6. History of prior malignant tumour, unless the patient has been without evidence of disease for at least 3 years or the tumour was a non-melanoma skin tumour or early cervical cancer |
| Date of first enrolment | 01/01/2003 |
| Date of final enrolment | 07/09/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Middlesex/UCL Hospitals
London
W1T 3AA
United Kingdom
W1T 3AA
United Kingdom
Sponsor information
Sponsor not defined - Record supplied by London Lung Cancer Group
Not defined
Not defined
-
London
-
United Kingdom
Funders
Funder type
Charity
London Lung Cancer Group (UK) (Charity no. 1074994) - LLCG study 14
No information available
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? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2009 | Yes | No | |
| Plain English results | 08/10/2010 | 29/10/2021 | No | Yes |
Editorial Notes
29/10/2021: The following changes have been made:
1. The Cancer Research UK lay results summary has been added.
2. The total final enrolment number has been added.
