Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
18/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Adele Galloway

ORCID ID

Contact details

Cancer Research UK Clinical Trials Unit (Beatson)
Dumbarton Road
Glasgow
G11 6NT
United Kingdom

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

http://www.cancer.org.uk

Funders

Funder type

Charity

Funder name

Cancer Research UK (UK)

Alternative name(s)

CRUK

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

Publication citations

Additional files

Editorial Notes

18/10/2016: No publications found, verifying study status with principal investigator.