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29 August 2008
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| [ Print-friendly version ] |
| Adjuvant interleukin-2, interferon-alpha and 5-fluorouracil for patients with high risk of relapse after surgical treatment for renal cell carcinoma |
| ISRCTN | ISRCTN16387614 |
| ClinicalTrials.gov identifier | NCT00053807 |
| Public title | Adjuvant interleukin-2, interferon-alpha and 5-fluorouracil for patients with high risk of relapse after surgical treatment for renal cell carcinoma |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | EORTC 30955 |
| Study hypothesis |
1. Compare the effect of adjuvant combination therapy comprising interleukin-2, interferon alfa, and fluorouracil versus observation only on disease-free survival or overall survival of patients with renal cell carcinoma at high risk of relapse after radical surgery.
2. Compare the quality of life of patients treated with these regimens. |
| Ethics approval | No ethics approval information required at time of registration. |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Cancer, kidney |
| Participants - inclusion criteria |
1. Surgical resection of primary renal cell carcinoma. A lymph node dissection to differentiate between N+ and N- is optional. Removal of clinical N+ disease is obligatory
2. No metastatic or macroscopic residual disease 3. Patients should have: a. Histologically proven T3b, T3c or T4 tumour or Any pT stage and nodal status pN1/2 or b. Any pT stage and microscopic positive margins or c. Presence of any microscopic vascular invasion 4. World Health Organisation (WHO) performance status zero or one 5. Aged 75 years or less 6. White Blood Cells (WBC) more than or equal to 3.5 x 10^9/l, platelets more than or equal to 100 x 10^9/l 7. Liver Function Tests (LFTs) less than or equal to 1.25 x Upper Limit of Normal (ULN), serum creatinine less than 1.5 x ULN 8. Randomisation to be carried out as close as possible to the time at which adjuvant surgery would begin, but no later than 12 weeks following surgery 9. Informed consent of the patient |
| Participants - exclusion criteria |
1. Unstable angina or Myocardial Infarction (MI)
2. Active infection requiring antibiotic 3. Major organ allograft 4. Patients likely to require corticosteroids for intercurrent disease 5. Pregnant/lactating women 6. Patients with concomitant or previous malignancies 7. Patients who have received radiation or chemotherapy |
| Anticipated start date | 19/02/1999 |
| Anticipated end date | 31/10/2006 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 214 |
| Interventions |
This is a randomised, multicenter study. Patients are randomised to one of two treatment arms:
Arm one: Patients receive interleukin-2 subcutaneously (SC) on days three, four, and five of weeks one and four and on days one, three, and five of weeks two and three. Patients also receive interferon alfa SC once weekly during weeks one and four and three times weekly during weeks two, three, five, six, seven, and eight. Patients then receive fluorouracil IV on day one of weeks five, six, seven, and eight. Arm II (control arm): Patients receive no adjuvant treatment before disease progression. Quality of life is assessed at baseline and at two and six months after randomisation. Patients are followed monthly for three months (arm one only), every three months for one year, every six months for four years, and then annually thereafter. |
| Primary outcome measure(s) | Compare the effect of adjuvant combination therapy comprising interleukin-2, interferon alfa, and fluorouracil versus observation only on disease-free survival or overall survival of patients with renal cell carcinoma at high risk of relapse after radical surgery. |
| Secondary outcome measure(s) | Compare the quality of life of patients treated with these regimens. |
| Sources of funding | Cancer Research UK (UK) |
| Trial website | |
| Publications | |
| Contact name | Mrs Adele Galloway |
| Address |
Cancer Research UK Clinical Trials Unit (Beatson)
Dumbarton Road |
| City/town | Glasgow |
| Zip/Postcode | G11 6NT |
| Country | United Kingdom |
| Sponsor | Cancer Research UK (CRUK) (UK) |
| Address |
PO Box 123
Lincoln's Inn Fields |
| City/town | London |
| Zip/Postcode | WC2A 3PX |
| Country | United Kingdom |
| Tel | +44 (0)20 7317 5186 |
| Fax | +44 (0)20 7487 4302 |
| kate.law@cancer.org.uk | |
| Sponsor website: | http://www.cancer.org.uk |
| Date applied | 01/07/2001 |
| Last edited | 30/01/2008 |
| Date ISRCTN assigned | 01/07/2001 |
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