Low-dose IL-2 Plus IFN-alpha Immunotherapy as Adjuvant Treatment of Renal Carcinoma.
Adjuvant Low-dose Interleukin-2 (IL2) Plus Interferone-alpha (IFN) in Operable Renal Cell Cancer (RCC). Phase III, Randomized, Multicenter Trial of the Italian Oncology Group for Clinical Research (GOIRC).
1 other identifier
interventional
310
1 country
8
Brief Summary
The aim of this study is to compare the efficacy (in terms of event-free survival and overall survival) of an adjuvant therapy with IFN-alpha plus low-dose of IL2 vs a wait-and-see program in patient with radically operated renal cell carcinoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 1994
Longer than P75 for phase_3
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 1994
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 16, 2007
CompletedFirst Posted
Study publicly available on registry
July 17, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedJuly 10, 2013
July 1, 2013
12.8 years
July 16, 2007
July 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrence-free survival: loco-regional, adrenal, kidney and distant-metastases were the events considered for event-free survival.
Secondary Outcomes (1)
Tolerability, toxicity and safety.
Study Arms (2)
A-immunotherapy
EXPERIMENTALImmunotherapy with interferon-alpha and interleukin
B-follow-up
NO INTERVENTIONWait-and-see
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis histologically confirmed of renal cells carcinoma (every histotype);
- Age \< 75 years
- Radical surgical removal of the tumor: total or partial nephrectomy within previous 3 months
- Patient classified as T1 (with diameter \> 2,5 cm), T2, T3 a-b-c; In presence of involvement of loco-regional lymph-nodes (staging N1, N2, N3, TNM class.), metastases should have been completely removed during nephrectomy
- Absence of distant metastases;
- Written informed consent
You may not qualify if:
- Tumor diameter equal or less than 2,5 cm;
- Previous chemotherapy or ormonotherapy o immunotherapy;
- Renal insufficiency \>3 mg/dl);
- No symptomatic arrhythmias or autoimmune disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Carpi Hospital
Carpi, Modena, 41012, Italy
Ospedali Riuniti di Bergamo
Bergamo, 24128, Italy
Istituti Ospitalieri di Cremona
Cremona, 26100, Italy
Modena University Hospital
Modena, 41100, Italy
Parma University Hospital
Parma, 43100, Italy
Pavia University Hospital
Pavia, 27100, Italy
Ospedale "Guglielmo da Saliceto"
Piacenza, 29100, Italy
Arcispedale Santa Maria Nuova
Reggio Emilia, 42100, Italy
Related Publications (5)
Passalacqua R, Buti S, Tomasello G, Longarini R, Brighenti M, Dalla Chiesa M. Immunotherapy options in metastatic renal cell cancer: where we are and where we are going. Expert Rev Anticancer Ther. 2006 Oct;6(10):1459-72. doi: 10.1586/14737140.6.10.1459.
PMID: 17069530BACKGROUNDGiacosa R, Santi R, Vaglio A, Pavone L, Ferrozzi F, Passalacqua R, Buzio C. "Late" regressions of metastases from renal cancer after a period of disease progression continuing the same intermittent low dose immunotherapy regimen. Acta Biomed. 2004 Aug;75(2):126-30.
PMID: 15481703BACKGROUNDBuzio C, Andrulli S, Santi R, Pavone L, Passalacqua R, Potenzoni D, Ferrozzi F, Giacosa R, Vaglio A. Long-term immunotherapy with low-dose interleukin-2 and interferon-alpha in the treatment of patients with advanced renal cell carcinoma. Cancer. 2001 Nov 1;92(9):2286-96. doi: 10.1002/1097-0142(20011101)92:93.0.co;2-i.
PMID: 11745283BACKGROUNDBuzio C, De Palma G, Passalacqua R, Potenzoni D, Ferrozzi F, Cattabiani MA, Manenti L, Borghetti A. Effectiveness of very low doses of immunotherapy in advanced renal cell cancer. Br J Cancer. 1997;76(4):541-4. doi: 10.1038/bjc.1997.422.
PMID: 9275034BACKGROUNDPassalacqua R, Caminiti C, Buti S, Porta C, Camisa R, Braglia L, Tomasello G, Vaglio A, Labianca R, Rondini E, Sabbatini R, Nastasi G, Artioli F, Prati A, Potenzoni M, Pezzuolo D, Oliva E, Alberici F, Buzio C; POLAR-01 Trial Investigators. Adjuvant low-dose interleukin-2 (IL-2) plus interferon-alpha (IFN-alpha) in operable renal cell carcinoma (RCC): a phase III, randomized, multicentre trial of the Italian Oncology Group for Clinical Research (GOIRC). J Immunother. 2014 Nov-Dec;37(9):440-7. doi: 10.1097/CJI.0000000000000055.
PMID: 25304727DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Rodolfo Passalacqua, Medicine
Gruppo Oncologico Italiano di Ricerca Clinica
- STUDY CHAIR
Carlo Buzio, Medicine
Parma University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2007
First Posted
July 17, 2007
Study Start
July 1, 1994
Primary Completion
April 1, 2007
Study Completion
June 1, 2012
Last Updated
July 10, 2013
Record last verified: 2013-07