Radiation Therapy in Patients With Limited-Stage Small Cell Lung Cancer in Complete Remission
NCT ID: NCT00005062
Last Updated: 2014-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
1999-09-30
2005-12-31
Brief Summary
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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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Detailed Description
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* Compare high-dose versus standard-dose prophylactic cranial radiotherapy in terms of the incidence of brain metastases and overall and disease free survival at 2 years in patients with limited stage small cell lung cancer in complete remission.
* Evaluate the quality of life and late sequelae in this patient population treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, age (60 and under vs over 60), and interval between the start of induction therapy and date of randomization (90 days or less vs 91-180 days vs more than 180 days). Patients are randomized into one of two treatment arms according to the prophylactic cranial radiotherapy dose.
* Arm I: Patients receive standard-dose prophylactic cranial radiotherapy (10 fractions/12 days).
* Arm II: Patients receive high-dose prophylactic cranial radiotherapy administered over 16 or 24 days based on the choice of their treatment center.
* 18 fractions/24 days (conventional radiotherapy) OR
* 24 fractions/16 days (accelerated hyperfractionated radiotherapy) Patients with isolated brain failure may undergo further radiotherapy.
Quality of life is assessed prior to randomization, at 6 months, at 1 year, and then annually thereafter.
Patients are followed at least every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 700 patients will be accrued for this study within 3 years.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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
70 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Gustave Roussy, Cancer Campus, Grand Paris
OTHER
Principal Investigators
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Cecile Le Pechoux, MD
Role:
Gustave Roussy, Cancer Campus, Grand Paris
Suresh Senan
Role:
Free University Medical Center
Locations
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M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
Cancer Therapy Centre at Campbelltown Hospital
Campbelltown, New South Wales, Australia
Radiation Oncology Victoria
East Melbourne, Victoria, Australia
Ziekenhuis Netwerk Antwerpen Middelheim
Antwerp, , Belgium
Universiteit Gent
Ghent, , Belgium
Hopital de Jolimont
Haine-Saint-Paul, , Belgium
Cazk Groeninghe - Campus Maria's Voorzienigheid
Kortrijk, , Belgium
Clinique Saint-Joseph
Liège, , Belgium
Clinique Sainte Elisabeth
Namur, , Belgium
Instituto Nacional de Cancer
Copacabana, Rio de Janeiro, Brazil
Instituto de Radiomedicina
Santiago, , Chile
Clinica Renaca - Gocchi
Viña del Mar, , Chile
Rui Jin Hospital
Shanghai, , China
Hospital Militar Central
Bogotá, , Colombia
Bank Of Cyprus Oncology Centre
Nicosia, , Cyprus
Masaryk Memorial Cancer Institute
Brno, , Czechia
First Medical Clinic of Charles University Hospital
Prague, , Czechia
Clinique De Rochebelle
Alès, , France
Centre de Traitement Hautes - Energies
Amiens, , France
Centre Paul Papin
Angers, , France
Centre Hospitalier Victor Dupouy
Argenteuil, , France
C.H.G. Beauvais
Beauvais, , France
Polyclinique Bordeaux Nord Aquitaine
Boucher, , France
Centre Regional Francois Baclesse
Caen, , France
Centre Jean Perrin
Clermont-Ferrand, , France
Centre de Radiotherapie
Compiègne, , France
Centre Hospitalier Sud Francilien - Site Corbeil
Corbeil, , France
Centre Hospitalier Universitaire Henri Mondor
Créteil, , France
Hopital Intercommunal De Creteil
Créteil, , France
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, , France
Centre De Radiotherapie Charlebourg
La Garenne-Colombes, , France
Centre Guillaume Le Conquerant
Le Havre, , France
Centre Hospital Regional Universitaire de Limoges
Limoges, , France
C.R.T.T.
Meudon-la-Forêt, , France
C.H. General De Montbelliard
Montbelliard, , France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, , France
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, , France
Centre Antoine Lacassagne
Nice, , France
CHR D'Orleans - Hopital de la Source
Orléans, , France
Institut Curie - Section Medicale
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Institut Jean Godinot
Reims, , France
Centre Frederic Joliot
Rouen, , France
Centre du Rouget
Sarcelles, , France
Centre Hospitalier Prive Des Yvelines
Sartrouville, , France
Hopitaux Universitaire de Strasbourg
Strasbourg, , France
Centre Medico-Chirurgical Foch
Suresnes, , France
Hopital d'Instruction des Armes Sainte-Anne
Toulon, , France
Centre d'Oncologie Saint-Yves
Vannes, , France
Institut Gustave Roussy
Villejuif, , France
Universitaetsklinikum Essen
Essen, , Germany
University Hospital of Heraklion
Heraklion, Crete, Greece
Evaggelismos Hospital
Athens, , Greece
Sotiria Hospital Chest Diseases
Athens, , Greece
Venizelion Gr.
Heraklion, , Greece
University of Patras Medical School
Rio Patras, , Greece
Tel-Aviv Sourasky Medical Center
Tel Aviv, , Israel
Chaim Sheba Medical Center
Tel Litwinsky, , Israel
Ospedale Bellaria
Bologna, , Italy
Universita Degli Studi Di Pisa
Pisa, , Italy
Ospedale Ostetrico Ginecologica Sant Anna
Turin, , Italy
Osaka National Hospital
Osaka, , Japan
Institute of Oncology at Vilnius University
Vilnius, , Lithuania
Akademisch Ziekenhuis Vrije Universiteit - Medisch Centrum
Amsterdam, , Netherlands
Arnhems Radiotherapeutisch Instituut
Arnhem, , Netherlands
Nijmegen Cancer Center at Radboud University Medical Center
Nijmegen, , Netherlands
University Medical Center Rotterdam at Erasmus Medical Center
Rotterdam, , Netherlands
Institute of Radiotherapy and Oncology
Skopje, , North Macedonia
Medical University of Gdansk
Gdansk, , Poland
Institute of Oncology
Lodz, , Poland
Regional Lung Diseases Hospital
Poznan, , Poland
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, , Poland
Hospital Santa Maria
Lisbon, , Portugal
Institutul Oncologic - Universitatea de Medicina
Cluj-Napoca, , Romania
Institute of Oncology and Radiology of Serbia
Belgrade, , Serbia
Groote Schuur Hospital
Cape Town, , South Africa
Samsung Medical Center
Seoul, , South Korea
Hospital Virgen de la Arrixaca
El Palmar, , Spain
Hospital Virgen de las Nieves
Granada, , Spain
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Marmara University Hospital
Istanbul, , Turkey (Türkiye)
Christie Hospital N.H.S. Trust
Manchester, England, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle upon Tyne, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom
New Cross Hospital
Wolverhampton, England, United Kingdom
Western General Hospital
Edinburgh, Scotland, United Kingdom
Beatson Oncology Centre
Glasgow, Scotland, United Kingdom
Raigmore Hospital
Inverness, Scotland, United Kingdom
Nevill Hall Hospital
Gwent, Wales, United Kingdom
Royal Gwent Hospital
Newport Gwent, Wales, United Kingdom
Velindre Cancer Center at Velinde Hospital
Cardiff, , United Kingdom
Cancer Research Centre at Weston Park Hospital
Sheffield, , United Kingdom
Countries
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References
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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.
Other Identifiers
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FRE-IGR-PCI-99
Identifier Type: -
Identifier Source: secondary_id
EU-99051
Identifier Type: -
Identifier Source: secondary_id
FRE-IFCT-99.01
Identifier Type: -
Identifier Source: secondary_id
FRE-IGR-PCI99-EULINT1
Identifier Type: -
Identifier Source: secondary_id
EORTC-22003
Identifier Type: -
Identifier Source: secondary_id
EORTC-08004
Identifier Type: -
Identifier Source: secondary_id
CDR0000067664
Identifier Type: -
Identifier Source: org_study_id
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