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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00005062




Registration number
NCT00005062
Ethics application status
Date submitted
6/04/2000
Date registered
27/01/2003
Date last updated
13/03/2014

Titles & IDs
Public title
Radiation Therapy in Patients With Limited-Stage Small Cell Lung Cancer in Complete Remission
Scientific title
A Phase III Trial Comparing High Versus Standard Dose of Prophylactic Cranial Irradiation (PCI) in Limited Small Cell Lung Cancer Complete Responders
Secondary ID [1] 0 0
FRE-IGR-PCI-99
Secondary ID [2] 0 0
CDR0000067664
Universal Trial Number (UTN)
Trial acronym
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
Primary outcome [1] 0 0
Incidence of brain metastases 2 years after randomization
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Overall survival and disease-free survival 2 years after randomization
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Quality of life as assessed by Quality of Life Questionnaire (QLQ)-C30/BN20 before randomization, at 6 and 12 months, and annually thereafter
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Treatment late sequelae as assessed by Late Effect of Normal Tissue - Subjective Objective Management Analytic scale, brain CT scan, or MRI before randomization and then annually thereafter
Timepoint [3] 0 0

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

* Histologically proven limited stage small cell lung cancer
* Complete response to induction therapy (at least on chest x-ray)
* Normal brain CT scan or MRI less than 1 month prior to study
* No metastases (including ipsilateral lung metastases and malignant pleural effusion)

PATIENT CHARACTERISTICS:

Age:

* 70 and under

Performance status:

* WHO 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Cardiovascular:

* No prior cerebrovascular disease

Other:

* No epilepsy requiring permanent oral medication
* No other prior malignancy except skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* See Disease Characteristics
* No concurrent chemotherapy

Endocrine therapy:

* Concurrent steroids allowed

Radiotherapy:

* Concurrent thoracic radiotherapy allowed

Surgery:

* Not specified

Other

* No other concurrent antitumoral agent
Minimum age
No limit
Maximum age
70 Years
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
1/09/1999
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2005
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Cancer Therapy Centre at Campbelltown Hospital - Campbelltown
Recruitment hospital [2] 0 0
Radiation Oncology Victoria - East Melbourne
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas
Country [2] 0 0
Belgium
State/province [2] 0 0
Antwerpen
Country [3] 0 0
Belgium
State/province [3] 0 0
Ghent
Country [4] 0 0
Belgium
State/province [4] 0 0
Haine Saint Paul
Country [5] 0 0
Belgium
State/province [5] 0 0
Kortrijk
Country [6] 0 0
Belgium
State/province [6] 0 0
Liege
Country [7] 0 0
Belgium
State/province [7] 0 0
Namur
Country [8] 0 0
Brazil
State/province [8] 0 0
Rio de Janeiro
Country [9] 0 0
Chile
State/province [9] 0 0
Santiago
Country [10] 0 0
Chile
State/province [10] 0 0
Vina Del Mar
Country [11] 0 0
China
State/province [11] 0 0
Shanghai
Country [12] 0 0
Colombia
State/province [12] 0 0
Bogota
Country [13] 0 0
Cyprus
State/province [13] 0 0
Nicosia
Country [14] 0 0
Czech Republic
State/province [14] 0 0
Brno
Country [15] 0 0
Czech Republic
State/province [15] 0 0
Prague
Country [16] 0 0
France
State/province [16] 0 0
Ales
Country [17] 0 0
France
State/province [17] 0 0
Amiens
Country [18] 0 0
France
State/province [18] 0 0
Angers
Country [19] 0 0
France
State/province [19] 0 0
Argenteuil
Country [20] 0 0
France
State/province [20] 0 0
Beauvais
Country [21] 0 0
France
State/province [21] 0 0
Boucher
Country [22] 0 0
France
State/province [22] 0 0
Caen
Country [23] 0 0
France
State/province [23] 0 0
Clermont-Ferrand
Country [24] 0 0
France
State/province [24] 0 0
Compiegne
Country [25] 0 0
France
State/province [25] 0 0
Corbeil
Country [26] 0 0
France
State/province [26] 0 0
Creteil
Country [27] 0 0
France
State/province [27] 0 0
Dijon
Country [28] 0 0
France
State/province [28] 0 0
La Garenne Colombes
Country [29] 0 0
France
State/province [29] 0 0
Le Havre
Country [30] 0 0
France
State/province [30] 0 0
Limoges
Country [31] 0 0
France
State/province [31] 0 0
Meudon La Foret
Country [32] 0 0
France
State/province [32] 0 0
Montbelliard
Country [33] 0 0
France
State/province [33] 0 0
Montpellier
Country [34] 0 0
France
State/province [34] 0 0
Nantes-Saint Herblain
Country [35] 0 0
France
State/province [35] 0 0
Nice
Country [36] 0 0
France
State/province [36] 0 0
Orleans
Country [37] 0 0
France
State/province [37] 0 0
Paris
Country [38] 0 0
France
State/province [38] 0 0
Pierre Benite
Country [39] 0 0
France
State/province [39] 0 0
Reims
Country [40] 0 0
France
State/province [40] 0 0
Rouen
Country [41] 0 0
France
State/province [41] 0 0
Sarcelles
Country [42] 0 0
France
State/province [42] 0 0
Sartrouville
Country [43] 0 0
France
State/province [43] 0 0
Strasbourg
Country [44] 0 0
France
State/province [44] 0 0
Suresnes
Country [45] 0 0
France
State/province [45] 0 0
Toulon
Country [46] 0 0
France
State/province [46] 0 0
Vannes
Country [47] 0 0
France
State/province [47] 0 0
Villejuif
Country [48] 0 0
Germany
State/province [48] 0 0
Essen
Country [49] 0 0
Greece
State/province [49] 0 0
Crete
Country [50] 0 0
Greece
State/province [50] 0 0
Athens
Country [51] 0 0
Greece
State/province [51] 0 0
Heraklion
Country [52] 0 0
Greece
State/province [52] 0 0
Rio Patras
Country [53] 0 0
Israel
State/province [53] 0 0
Tel Hashomer
Country [54] 0 0
Israel
State/province [54] 0 0
Tel-Aviv
Country [55] 0 0
Italy
State/province [55] 0 0
Bologna
Country [56] 0 0
Italy
State/province [56] 0 0
Pisa
Country [57] 0 0
Italy
State/province [57] 0 0
Turin
Country [58] 0 0
Japan
State/province [58] 0 0
Osaka
Country [59] 0 0
Korea, Republic of
State/province [59] 0 0
Seoul
Country [60] 0 0
Lithuania
State/province [60] 0 0
Vilnius
Country [61] 0 0
Macedonia, The Former Yugoslav Republic of
State/province [61] 0 0
Skopje
Country [62] 0 0
Netherlands
State/province [62] 0 0
Amsterdam
Country [63] 0 0
Netherlands
State/province [63] 0 0
Arnhem
Country [64] 0 0
Netherlands
State/province [64] 0 0
Nijmegen
Country [65] 0 0
Netherlands
State/province [65] 0 0
Rotterdam
Country [66] 0 0
Poland
State/province [66] 0 0
Gdansk
Country [67] 0 0
Poland
State/province [67] 0 0
Lodz
Country [68] 0 0
Poland
State/province [68] 0 0
Poznan
Country [69] 0 0
Poland
State/province [69] 0 0
Warsaw
Country [70] 0 0
Portugal
State/province [70] 0 0
Lisbon
Country [71] 0 0
Romania
State/province [71] 0 0
Cluj-Napoca
Country [72] 0 0
Serbia
State/province [72] 0 0
Belgrade
Country [73] 0 0
South Africa
State/province [73] 0 0
Cape Town
Country [74] 0 0
Spain
State/province [74] 0 0
El Palmar
Country [75] 0 0
Spain
State/province [75] 0 0
Granada
Country [76] 0 0
Switzerland
State/province [76] 0 0
Lausanne
Country [77] 0 0
Turkey
State/province [77] 0 0
Istanbul
Country [78] 0 0
United Kingdom
State/province [78] 0 0
England
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Scotland
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Wales
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Cardiff
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Other
Name
Gustave Roussy, Cancer Campus, Grand Paris
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
European Organisation for Research and Treatment of Cancer - EORTC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Cecile Le Pechoux, MD
Address 0 0
Gustave Roussy, Cancer Campus, Grand Paris
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Le Pechoux C, Laplanche A, Faivre-Finn C, Ciuleanu... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT00005062