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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Treatment: Other - radiation therapy

Treatment: Other: radiation therapy
Intervention code [1] 0 0
Treatment: Other
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
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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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Brazil
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Rio de Janeiro
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Chile
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Santiago
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Chile
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Vina Del Mar
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China
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Shanghai
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Colombia
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Bogota
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Cyprus
State/province [13] 0 0
Nicosia
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Czech Republic
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Brno
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Czech Republic
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Prague
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France
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Ales
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France
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Amiens
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France
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Angers
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France
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Argenteuil
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Beauvais
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Boucher
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France
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Caen
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France
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Clermont-Ferrand
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France
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Compiegne
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France
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Corbeil
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France
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Creteil
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France
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Dijon
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France
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La Garenne Colombes
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France
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Le Havre
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France
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Limoges
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France
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Meudon La Foret
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France
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Montbelliard
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France
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Montpellier
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France
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Nantes-Saint Herblain
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France
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Nice
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France
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Orleans
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France
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Paris
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France
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Pierre Benite
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France
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Reims
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France
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Rouen
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France
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Sarcelles
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France
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Sartrouville
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France
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Strasbourg
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France
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Suresnes
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France
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Toulon
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France
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Vannes
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France
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Villejuif
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Germany
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Essen
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Greece
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Crete
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Greece
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Athens
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Greece
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Heraklion
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Greece
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Rio Patras
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Israel
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Tel Hashomer
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Israel
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Tel-Aviv
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Italy
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Bologna
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Italy
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Pisa
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Italy
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Turin
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Japan
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Osaka
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Korea, Republic of
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Seoul
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Lithuania
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Vilnius
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Macedonia, The Former Yugoslav Republic of
State/province [61] 0 0
Skopje
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Netherlands
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Amsterdam
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Netherlands
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Arnhem
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Netherlands
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Nijmegen
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Netherlands
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Rotterdam
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Poland
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Gdansk
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Poland
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Lodz
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Poland
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Poznan
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Poland
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Warsaw
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Portugal
State/province [70] 0 0
Lisbon
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Romania
State/province [71] 0 0
Cluj-Napoca
Country [72] 0 0
Serbia
State/province [72] 0 0
Belgrade
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South Africa
State/province [73] 0 0
Cape Town
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Spain
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El Palmar
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Spain
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Granada
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Switzerland
State/province [76] 0 0
Lausanne
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Turkey
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Istanbul
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United Kingdom
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England
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United Kingdom
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Scotland
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United Kingdom
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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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00005062
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.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00005062