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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00003279




Registration number
NCT00003279
Ethics application status
Date submitted
1/11/1999
Date registered
25/08/2004
Date last updated
6/03/2012

Titles & IDs
Public title
Vaccination Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
Scientific title
The SILVA Study: Survival in an International Phase III Prospective Randomized LD Small Cell Lung Cancer Vaccination Study With Adjuvant BEC2 and BCG
Secondary ID [1] 0 0
EORTC-08971
Secondary ID [2] 0 0
EORTC-08971
Universal Trial Number (UTN)
Trial acronym
SILVA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS: Histologically or cytologically proven limited stage small cell lung cancer (SCLC) Must have completed adequate first-line combined modality treatment comprising at least 4-6 courses of a 2-drug chemotherapy regimen and chest radiotherapy No evidence of disease progression or relapse Disease response (complete or partial) after treatment

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC greater that 3,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: AST less than 1.5 times upper limit of normal Hepatitis B negative Renal: Not specified Cardiovascular: Adequate cardiac function Other: HIV negative Not pregnant or nursing Fertile patients must use effective contraception No prior malignancy within 5 years except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix No history of tuberculosis No grade 3 local skin toxicity reaction (ulceration) to 5 IU or greater of PPD test No active infections requiring systemic antibiotics, antiviral, or antifungal treatments No serious unstable chronic illnesses No psychological, familial, sociological, or geographical condition that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior therapy with proteins of murine origin At least one month since prior immunotherapy No other concurrent immunotherapy Chemotherapy: See Disease Characteristics No concurrent chemotherapy Endocrine therapy: No concurrent chronic use of systemic corticosteroids Radiotherapy: See Disease Characteristics No concurrent radiotherapy including prophylactic cranial irradiation No prior spleen radiotherapy Surgery: No prior surgery for SCLC No prior splenectomy Other: No prior second-line therapy for SCLC At least one month since prior investigational agents No concurrent chronic use of systemic antihistamines or nonsteroidal anti-inflammatory drugs No concurrent immunosuppressive therapy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/1998
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital, Sydney - Camperdown
Recruitment hospital [2] 0 0
Repatriation General Hospital - Concord
Recruitment hospital [3] 0 0
Newcastle Mater Misericordiae Hospital - Newcastle
Recruitment hospital [4] 0 0
Nepean Hospital - Penrith
Recruitment hospital [5] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [6] 0 0
NSW Breast Cancer Institute - Westmead
Recruitment hospital [7] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [8] 0 0
Monash Medical Center - East Bentweigh
Recruitment hospital [9] 0 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment hospital [10] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [11] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
NSW 2310 - Newcastle
Recruitment postcode(s) [4] 0 0
2750 - Penrith
Recruitment postcode(s) [5] 0 0
2065 - St. Leonards
Recruitment postcode(s) [6] 0 0
2145 - Westmead
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
3165 - East Bentweigh
Recruitment postcode(s) [9] 0 0
8006 - East Melbourne
Recruitment postcode(s) [10] 0 0
3050 - Parkville
Recruitment postcode(s) [11] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
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United States of America
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California
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United States of America
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Colorado
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United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
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United States of America
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Massachusetts
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United States of America
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Minnesota
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Montana
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United States of America
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Nevada
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New Jersey
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Oklahoma
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United States of America
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Rhode Island
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United States of America
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Texas
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United States of America
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West Virginia
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United States of America
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Wisconsin
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Austria
State/province [22] 0 0
Vienna (Wein)
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Belgium
State/province [23] 0 0
Leuven
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Germany
State/province [24] 0 0
Berlin
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Germany
State/province [25] 0 0
Gauting, Munich (Munchen)
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Germany
State/province [26] 0 0
Grosshansdorf
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Germany
State/province [27] 0 0
Heidelberg
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Germany
State/province [28] 0 0
Herne
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Netherlands
State/province [29] 0 0
's-Hertogenbosch
Country [30] 0 0
Netherlands
State/province [30] 0 0
Amsterdam
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Netherlands
State/province [31] 0 0
Harderwijk
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Netherlands
State/province [32] 0 0
Nieuwegein
Country [33] 0 0
Netherlands
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Tilburg
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New Zealand
State/province [34] 0 0
Auckland
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New Zealand
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Wellington
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Spain
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Barakaldo, Bilbao
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Spain
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Barcelona
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Spain
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Elche
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Spain
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Madrid
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Spain
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San Sebastian
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Spain
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Valencia
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Spain
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Zaragoza
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Switzerland
State/province [43] 0 0
Basel
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Switzerland
State/province [44] 0 0
Bern
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Switzerland
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Chur
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Switzerland
State/province [46] 0 0
Saint Gallen
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United Kingdom
State/province [47] 0 0
England

Funding & Sponsors
Primary sponsor type
Other
Name
European Organisation for Research and Treatment of Cancer - EORTC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Vaccines may help the body build an immune response to kill tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of vaccination with monoclonal antibody BEC2 and BCG with that of no further therapy in treating patients who have limited-stage small cell lung cancer.
Trial website
https://clinicaltrials.gov/study/NCT00003279
Trial related presentations / publications
Bottomley A, Debruyne C, Felip E, Millward M, Thiberville L, D'Addario G, Rome L, Zatloukal P, Coens C, Giaccone G. Symptom and quality of life results of an international randomised phase III study of adjuvant vaccination with Bec2/BCG in responding patients with limited disease small-cell lung cancer. Eur J Cancer. 2008 Oct;44(15):2178-84. doi: 10.1016/j.ejca.2008.06.036.
Public notes

Contacts
Principal investigator
Name 0 0
Giuseppe Giaccone, MD, PhD
Address 0 0
Free University Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00003279