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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
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Scientific title
A Phase III Trial Comparing High Versus Standard Dose of Prophylactic Cranial Irradiation (PCI) in Limited Small Cell Lung Cancer Complete Responders
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Secondary ID [1]
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FRE-IGR-PCI-99
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Secondary ID [2]
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CDR0000067664
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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0
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of brain metastases 2 years after randomization
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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Overall survival and disease-free survival 2 years after randomization
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [2]
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Quality of life as assessed by Quality of Life Questionnaire (QLQ)-C30/BN20 before randomization, at 6 and 12 months, and annually thereafter
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Assessment method [2]
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Timepoint [2]
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Secondary outcome [3]
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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
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Assessment method [3]
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Timepoint [3]
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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
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Minimum age
No limit
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Maximum age
70
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/1999
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2005
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Cancer Therapy Centre at Campbelltown Hospital - Campbelltown
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Recruitment hospital [2]
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Radiation Oncology Victoria - East Melbourne
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Recruitment postcode(s) [1]
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2560 - Campbelltown
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Recruitment postcode(s) [2]
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3002 - East Melbourne
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Recruitment outside Australia
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United States of America
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Texas
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Belgium
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Antwerpen
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Belgium
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Ghent
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Belgium
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Haine Saint Paul
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Belgium
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Kortrijk
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Belgium
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Liege
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Belgium
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Namur
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Rio de Janeiro
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Santiago
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Chile
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Bogota
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Nicosia
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Brno
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Czech Republic
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Prague
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Paris
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Pierre Benite
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Belgrade
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Granada
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Lausanne
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Istanbul
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Cardiff
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United Kingdom
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Sheffield
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Funding & Sponsors
Primary sponsor type
Other
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Name
Gustave Roussy, Cancer Campus, Grand Paris
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Address
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Other collaborator category [1]
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Other
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Name [1]
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European Organisation for Research and Treatment of Cancer - EORTC
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Ethics approval
Ethics application status
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Summary
Brief summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells and prevent the spread of cancer to the brain. It is not yet known if standard-dose radiation therapy is more effective than high-dose radiation therapy in preventing the spread of limited-stage small cell lung cancer cells to the brain. PURPOSE: This randomized phase III trial is comparing two different regimens of radiation therapy to see how well they work in treating patients with limited-stage small cell lung cancer in complete remission.
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Trial website
https://clinicaltrials.gov/study/NCT00005062
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Trial related presentations / publications
Le Pechoux C, Dunant A, Senan S, Wolfson A, Quoix E, Faivre-Finn C, Ciuleanu T, Arriagada R, Jones R, Wanders R, Lerouge D, Laplanche A; Prophylactic Cranial Irradiation (PCI) Collaborative Group. Standard-dose versus higher-dose prophylactic cranial irradiation (PCI) in patients with limited-stage small-cell lung cancer in complete remission after chemotherapy and thoracic radiotherapy (PCI 99-01, EORTC 22003-08004, RTOG 0212, and IFCT 99-01): a randomised clinical trial. Lancet Oncol. 2009 May;10(5):467-74. doi: 10.1016/S1470-2045(09)70101-9. Epub 2009 Apr 20. Pechoux CL, Hatton M, Kobierska A, et al.: Randomized trial of standard dose to a higher dose prophylactic cranial irradiation (PCI) in limited-stage small cell cancer (SCLC) complete responders (CR): primary endpoint analysis (PCI99-01, IFCT 99-01, EORTC 22003-08004, RTOG 0212). [Abstract] J Clin Oncol 26 (Suppl 15): A-LBA7514, 2008. Le Pechoux C, Laplanche A, Faivre-Finn C, Ciuleanu T, Wanders R, Lerouge D, Keus R, Hatton M, Videtic GM, Senan S, Wolfson A, Jones R, Arriagada R, Quoix E, Dunant A; Prophylactic Cranial Irradiation (PCI) Collaborative Group. Clinical neurological outcome and quality of life among patients with limited small-cell cancer treated with two different doses of prophylactic cranial irradiation in the intergroup phase III trial (PCI99-01, EORTC 22003-08004, RTOG 0212 and IFCT 99-01). Ann Oncol. 2011 May;22(5):1154-1163. doi: 10.1093/annonc/mdq576. Epub 2010 Dec 7.
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Public notes
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Contacts
Principal investigator
Name
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Cecile Le Pechoux, MD
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Address
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Gustave Roussy, Cancer Campus, Grand Paris
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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
Type
Citations or Other Details
Journal
Le Pechoux C, Laplanche A, Faivre-Finn C, Ciuleanu...
[
More Details
]
Results not provided in
https://clinicaltrials.gov/study/NCT00005062
Download to PDF