Kidney CancerPhase 3NCT00053807
Interleukin-2, Interferon Alfa, and Fluorouracil Compared With Observation in Treating Patients Who Have Undergone Surgery for Kidney Cancer
A Phase 3 study testing aldesleukin, recombinant interferon alfa and fluorouracil in people with Kidney Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 17 sites in 8 countries.
Trial summary
RATIONALE: Interferon alfa may interfere with the growth of tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- aldesleukin, recombinant interferon alfa and fluorouracil
- Type of treatment
- Surgery or procedure
- How many people
- 96 participants
- Where
- 17 sitesin 8 countries
- Study dates
- Feb 1998to Jan 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed primary renal cell carcinoma meeting 1 of the following criteria:
- Stage T3b, T3c, or T4 tumor
- Any pT stage and nodal status pN 1 or 2
- Any pT stage and microscopic positive margins
- Presence of any microscopic vascular invasion
- Underwent surgical resection of primary tumor within the past month
- Removal of clinical N+ disease required
- No evidence of metastatic disease
- No evidence of macroscopic residual disease
PATIENT CHARACTERISTICS:
Age
- 75 and under
Performance status
- WHO 0-1
Life expectancy
- Not specified
Hematopoietic
- WBC at least 3,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Liver function tests no greater than 1.25 times upper limit of normal (ULN)
Renal
- Creatinine less than 1.5 times ULN
Cardiovascular
- No myocardial infarction within the past 6 months
- No unstable angina pectoris
Other
- Not pregnant or nursing
- No prior or other concurrent malignancies that would preclude study therapy or comparisons
- No other concurrent illness that would preclude study therapy
- No concurrent active infections requiring antibiotic therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No other concurrent immunotherapy
Chemotherapy
- No prior chemotherapy
Endocrine therapy
- No concurrent corticosteroids
- No concurrent hormonal therapy
Radiotherapy
- No prior radiotherapy
Surgery
- See Disease Characteristics
- No prior major organ allografts
Other
- No other concurrent investigational drugs, agents, or devices
Trial locations and contacts
17 sites in 8 countries.
17 sites in 8 countries
Netherlands6 sites
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, 5211 NL
Onze Lieve Vrouwe Gasthuis
Amsterdam, 1091 HA
Akademisch Medisch Centrum
Amsterdam, 1105 AZ
University Medical Center Nijmegen
Nijmegen, 6500 HB
Daniel Den Hoed Cancer Center at Erasmus University Medical Center
Rotterdam, 3075 EA
Academisch Ziekenhuis Utrecht
Utrecht, 3584 CX
Belgium4 sites
Onze Lieve Vrouw Ziekenhuis Aalst
Aalst, B-9300
Universitair Ziekenhuis Gent
Ghent, B-9000
AZ Groeninge - Campus St. Maarten
Kortrijk, 8500
U.Z. Gasthuisberg
Leuven, B-3000
Turkey (Türkiye)2 sites
Marmara University Hospital
Istanbul, 81190
Dokuz Eylul University School of Medicine
Izmir, 35340
United Kingdom1 site
Beatson Institute for Cancer Research - Glasgow
Glasgow, Scotland, G61 1BD
About this study
Official title: Adjuvant Interleukin-2, Interferon-alpha and 5-Fluorouracil for Patients With High Risk of Relapse After Surgical Treatment for Renal Cell Carcinoma
RATIONALE: Interferon alfa may interfere with the growth of tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining interferon alfa and interleukin-2 with fluorouracil may kill any remaining tumor cells following surgery. It is not yet known whether combining interferon alfa and interleukin-2 with fluorouracil is more effective than observation after surgery for kidney cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of combining interleukin-2, interferon alfa, and fluorouracil to that of observation alone in treating patients who have undergone surgery for kidney cancer and are at high risk of relapse.
Read the detailed description
OBJECTIVES:
- Compare the effect of adjuvant combination therapy comprising interleukin-2, interferon alfa, and fluorouracil vs observation only on disease-free survival or overall survival of patients with renal cell carcinoma at high risk of relapse after radical surgery.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive interleukin-2 subcutaneously (SC) on days 3, 4, and 5 of weeks 1 and 4 and on days 1, 3, and 5 of weeks 2 and 3. Patients also receive interferon alfa SC once weekly during weeks 1 and 4 and 3 times weekly during weeks 2, 3, 5, 6, 7, and 8. Patients then receive fluorouracil IV on day 1 of weeks 5, 6, 7, and 8.
- Arm II (control arm): Patients receive no adjuvant treatment before disease progression.
Quality of life is assessed at baseline and at 2 and 6 months after randomization.
Patients are followed monthly for 3 months (arm I only), every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 550 patients (275 per treatment arm) will be accrued for this study within 3 years.
- Conditions
- Kidney Cancer
- Being tested
- aldesleukin, recombinant interferon alfa, fluorouracil, adjuvant therapy
- Keywords
- stage III renal cell cancer, stage IV renal cell cancer
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aldesleukinBiological
recombinant interferon alfaBiological
fluorouracilDrug
adjuvant therapyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2003 (estimated)
- Study startFeb 1998
- Primary completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Pieter H. M. de Mulder, MD, PhD, Study chair, Universitair Medisch Centrum St. Radboud - NijmegenHein van Poppel, MD, PhD, Study chair, University Hospital, GasthuisbergPaul A. Vasey, MD, Study chair, Beatson Institute for Cancer Research - Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00053807
- Sponsor's protocol ID
- EORTC-30955
- Other IDs
- EORTC-30955
- Status last verified
- Sep 2012
- First submitted
- 5 Feb 2003
- Last updated
- 24 Sep 2012
- Results posted
- No
Publications
Aitchison M, Bray CA, Van Poppel H, et al.: Final results from an EORTC (GU Group)/NCRI randomized phase III trial of adjuvant interleukin-2, interferon alpha, and 5-fluorouracil in patients with a high risk of relapse after nephrectomy for renal cell carcinoma (RCC). [Abstract] J Clin Oncol 29 (Suppl 15): A-4505, 2011.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Interleukin-2, Interferon-alpha and 5-Fluorouracil for Patients With High Risk of Relapse After Surgical Treatment for Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00053807
- Acronym / sponsor ID
- EORTC-30955
- Conditions
- Kidney Cancer
- Keywords
- stage III renal cell cancer, stage IV renal cell cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Collaborators
- University of Glasgow
- Study start
- Feb 1998
- Primary completion
- Jan 2004 (actual)
- First posted
- 6 Feb 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Interferon alfa may interfere with the growth of tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining interferon alfa and interleukin-2 with fluorouracil may kill any remaining tumor cells following surgery. It is not yet known whether combining interferon alfa and interleukin-2 with fluorouracil is more effective than observation after surgery for kidney cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of combining interleukin-2, interferon alfa, and fluorouracil to that of observation alone in treating patients who have undergone surgery for kidney cancer and are at high risk of relapse.
Detailed description
OBJECTIVES:
- Compare the effect of adjuvant combination therapy comprising interleukin-2, interferon alfa, and fluorouracil vs observation only on disease-free survival or overall survival of patients with renal cell carcinoma at high risk of relapse after radical surgery.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive interleukin-2 subcutaneously (SC) on days 3, 4, and 5 of weeks 1 and 4 and on days 1, 3, and 5 of weeks 2 and 3. Patients also receive interferon alfa SC once weekly during weeks 1 and 4 and 3 times weekly during weeks 2, 3, 5, 6, 7, and 8. Patients then receive fluorouracil IV on day 1 of weeks 5, 6, 7, and 8.
- Arm II (control arm): Patients receive no adjuvant treatment before disease progression.
Quality of life is assessed at baseline and at 2 and 6 months after randomization.
Patients are followed monthly for 3 months (arm I only), every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 550 patients (275 per treatment arm) will be accrued for this study within 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aldesleukin | Biological | – |
| recombinant interferon alfa | Biological | – |
| fluorouracil | Drug | – |
| adjuvant therapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2012.
- Results publicationAitchison M, Bray CA, Van Poppel H, et al.: Final results from an EORTC (GU Group)/NCRI randomized phase III trial of adjuvant interleukin-2, interferon alpha, and 5-fluorouracil in patients with a high risk of relapse after nephrectomy for renal cell carcinoma (RCC). [Abstract] J Clin Oncol 29 (Suppl 15): A-4505, 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pieter H. M. de Mulder, MD, PhD study chair
Universitair Medisch Centrum St. Radboud - Nijmegen
Hein van Poppel, MD, PhD study chair
University Hospital, Gasthuisberg
Paul A. Vasey, MD study chair
Beatson Institute for Cancer Research - Glasgow
17 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing aldesleukin, recombinant interferon alfa and fluorouracil in people with Kidney Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 17 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Netherlands, Belgium, Turkey (Türkiye), Austria, Hungary and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00053807, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2012.