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21 March 2013
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| [ Print-friendly version ] |
| 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 | 10.1186/ISRCTN46518965 |
| ClinicalTrials.gov identifier | NCT00053820 |
| EudraCT number | |
| Public 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 |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | RE04 (E164/5) |
| 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 |
| Lay summary | http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=61 |
| Ethics approval |
Not provided at time of registration.
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| Study design | Randomised controlled trial |
| Countries of recruitment | Europe |
| Disease/condition/study domain | Renal Cancer |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 24/04/2001 |
| Anticipated end date | 31/07/2006 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 1100 |
| Interventions |
Arm 1: IFN-alpha until progression
Arm 2: IFN-alpha, IL-2 and 5-FU (max 2 cycles) |
| Primary outcome measure(s) | 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 measure(s) |
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 |
| Sources of funding | Medical Research Council (MRC) (UK) |
| Trial website | |
| Publications |
1. 2005 rationale and progress on http://www.ncbi.nlm.nih.gov/pubmed/16097560
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20153039 |
| Contact name | Prof Martin Gore |
| Address |
Royal Marsden Hospital
Fulham Road |
| City/town | London |
| Zip/Postcode | SW3 6JJ |
| Country | United Kingdom |
| Sponsor | Medical Research Council (MRC) (UK) |
| Address | 20 Park Crescent |
| City/town | London |
| Zip/Postcode | W1B 1AL |
| Country | United Kingdom |
| Tel | +44 (0)20 7636 5422 |
| Fax | +44 (0)20 7436 6179 |
| clinical.trial@headoffice.mrc.ac.uk | |
| Sponsor website: | http://www.mrc.ac.uk |
| Date applied | 08/11/2000 |
| Last edited | 04/08/2011 |
| Date ISRCTN assigned | 08/11/2000 |
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| © 2013 ISRCTN unless otherwise stated. | |
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