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 |
| ClinicalTrials.gov (NCT) | NCT00053807 |
| Clinical Trials Information System (CTIS) | 2004-000857-50 |
| Protocol serial number | EORTC 30955 |
| Sponsor | Cancer Research UK (CRUK) (UK) |
| Funder | Cancer Research UK (UK) |
- 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
Scientific
Cancer Research UK Clinical Trials Unit (Beatson)
Dumbarton Road
Glasgow
G11 6NT
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | 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 |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Interleukin-2, interferon-alpha, 5-fluorouracil |
| Primary outcome measure(s) |
Disease-free survival or overall survival |
| Key secondary outcome measure(s) |
Quality of life |
| Completion date | 31/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- Scotland
Study participating centre
Cancer Research UK Clinical Trials Unit (Beatson)
Glasgow
G11 6NT
United Kingdom
G11 6NT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 20/05/2011 | 28/01/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | No | Yes |
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.
