A randomised controlled trial of Interferon-alpha (IFN-alpha), Interleukin-2 (IL-2) and 5 Fluorourcil (5-FU) versus Interferon-alpha alone in patients with advanced renal cell carcinoma
| ISRCTN | ISRCTN46518965 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46518965 |
| ClinicalTrials.gov number | NCT00053820 |
| Secondary identifying numbers | RE04 (E164/5) |
- Submission date
- 08/11/2000
- Registration date
- 08/11/2000
- Last edited
- 18/10/2018
- 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
http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=61
Contact information
Prof Martin Gore
Scientific
Scientific
Royal Marsden Hospital
Fulham Road
London
SW3 6JJ
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A randomised controlled trial of Interferon-alpha (IFN-alpha), Interleukin-2 (IL-2) and 5 Fluorourcil (5-FU) versus Interferon-alpha alone in patients with advanced renal cell carcinoma |
| Study hypothesis | 1. The value of triple combination therapy in terms of overall survival in patients with advanced metastatic renal cell carcinoma compared with IFN-alpha alone 2. The value of triple combination therapy in terms of progression-free survival time and toxicity compared with IFN-alpha alone 3. The Quality of Life of patients in both treatment arms during therapy and follow-up 4. The health economic implications of using triple therapy compared to the control regimen |
| Ethics approval(s) | Not provided at time of registration. |
| Condition | Renal Cancer |
| Intervention | Arm 1: IFN-alpha until progression Arm 2: IFN-alpha, IL-2 and 5-FU (max 2 cycles) |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Interferon-alpha (IFN-alpha), Interleukin-2 (IL-2) and 5 Fluorourcil (5-FU) |
| Primary outcome measure | The primary endpoint is survival. The primary endpoint, which will be used to evaluate the efficacy of the treatment regimens, will be time to death. All deaths should be reported immediately and time to death will be calculated from the date of randomisation. |
| Secondary outcome measures | 1. Time to disease progression. Progression is defined according to the RECIST guidelines 2. Comparison of toxicity levels, principally grade III/IV 3. Quality of life will be assessed before, during and after treatment 4. The impact of the treatment regimens on health economics will also be evaluated |
| Overall study start date | 24/04/2001 |
| Overall study end date | 31/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1100 |
| Participant inclusion criteria | 1. Histologically proven renal cell carcinoma. Material may be obtained from the primary tumour or the metastases 2. Advanced metastatic disease that, in the opinion of the investigator, requires treatment. (We would recommend that patients have undergone resection of their primary tumour prior to entry into the trial but this is not mandatory) 3. At least one measurable lesion. Measurements must be taken within the 4 week period before the start of treatment (single bone lesions should not be included due to assessing response) 4. WHO performance status 0 or 1 5. Normal haematological parameters (WBC >3 x 109/l; platelets >100 x 109/l; haemoglobin >10g/dl). This assessment should be carried out within 7 days before randomisation 6. Creatinine levels must be within normal limits for institution. If creatinine raised, then EDTA or creatinine clearance should be greater than 60ml/min 7. Life expectancy greater than 12 weeks 8. Written informed consent 9. Male or female patient of any ethnic group more than 18 years in age |
| Participant exclusion criteria | 1. No radiotherapy to target lesions during trial therapy 2. Previous chemotherapy, endocrine therapy or treatment with biological agents 3. No current or previous brain metastasis 4. Unstable angina pectoris or recent (6 month) myocardial infarction 5. Evidence of active infections requiring antibiotic therapy 6. Patients with major organ allografts (IL-2 may increase T-cell mediated rejection and immunosuppressive agents are likely to reduce efficacy of IL-2 and IFN-alpha 7. Patients who require or are likely to require corticosteroids for intercurrent disease 8. Pregnant or lactating women 9. Other disease or previous malignancy likely to interfere with the protocol treatments or comparisons 10. Patients with concurrent malignancy, unless they have remained free of the disease attributed to the malignancy for more than 5 years |
| Recruitment start date | 24/04/2001 |
| Recruitment end date | 31/07/2006 |
Locations
Countries of recruitment
- Belgium
- Denmark
- England
- Germany
- Netherlands
- Slovakia
- United Kingdom
Study participating centre
Royal Marsden Hospital
London
SW3 6JJ
United Kingdom
SW3 6JJ
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? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Other publications | rationale and progress | 01/08/2005 | Yes | No | |
| Results article | results | 20/02/2010 | Yes | No |
Editorial Notes
18/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
