Adjuvant interleukin-2, interferon-alpha and 5-fluorouracil for patients with high risk of relapse after surgical treatment for renal cell carcinoma

ISRCTN	ISRCTN16387614
DOI	https://doi.org/10.1186/ISRCTN16387614
EudraCT/CTIS number	2004-000857-50
ClinicalTrials.gov number	NCT00053807
Secondary identifying numbers	EORTC 30955

Submission date: 01/07/2001
Registration date: 01/07/2001
Last edited: 28/01/2019

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

Not provided at time of registration

Contact information

Mrs Adele Galloway
Scientific

Cancer Research UK Clinical Trials Unit (Beatson)
Dumbarton Road
Glasgow
G11 6NT
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
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Adjuvant interleukin-2, interferon-alpha and 5-fluorouracil for patients with high risk of relapse after surgical treatment for renal cell carcinoma
Study objectives	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(s)	No ethics approval information required at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Interleukin-2, interferon-alpha, 5-fluorouracil
Primary outcome measure	Disease-free survival or overall survival
Secondary outcome measures	Quality of life
Overall study start date	19/02/1999
Completion date	31/10/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	214
Key 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
Key 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
Date of first enrolment	19/02/1999
Date of final enrolment	31/10/2006

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

Cancer Research UK Clinical Trials Unit (Beatson)

Glasgow
G11 6NT
United Kingdom

Sponsor information

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Phone	+44 (0)207 317 5186
Email	kate.law@cancer.org.uk
Website	http://www.cancer.org.uk
"ROR"	https://ror.org/054225q67

Funders

Funder type

Charity

Cancer Research UK (UK)
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
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
Results article	results	20/05/2011	28/01/2019	Yes	No

Editorial Notes

28/01/2019: Publication reference added
17/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
18/10/2016: No publications found, verifying study status with principal investigator.