Additional identifiers
EudraCT number
2004-000857-50
ClinicalTrials.gov number
NCT00053807
Protocol/serial number
EORTC 30955
Study information
Scientific title
Adjuvant interleukin-2, interferon-alpha and 5-fluorouracil for patients with high risk of relapse after surgical treatment for renal cell carcinoma
Acronym
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Cancer, kidney
Intervention
This is a randomised, multicenter study. Patients are randomised to one of two treatment arms:
Arm 1: 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 2 (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.
Intervention type
Drug
Phase
Phase III
Drug names
Interleukin-2, interferon-alpha, 5-fluorouracil
Primary outcome measures
Disease-free survival or overall survival
Secondary outcome measures
Quality of life
Overall trial start date
19/02/1999
Overall trial end date
31/10/2006
Reason abandoned
Eligibility
Participant 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:
1.1. Histologically proven T3b, T3c or T4 tumour or Any pT stage and nodal status pN1/2 or
1.2. Any pT stage and microscopic positive margins or
1.3. 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
214
Participant 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
Recruitment start date
19/02/1999
Recruitment end date
31/10/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cancer Research UK Clinical Trials Unit (Beatson)
Glasgow
G11 6NT
United Kingdom
Sponsor information
Organisation
Cancer Research UK (CRUK) (UK)
Sponsor details
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary