Radiation Therapy in Patients With Limited-Stage Small Cell Lung Cancer in Complete Remission
- Conditions
- Lung Cancer
- Registration Number
- NCT00005062
- Lead Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- 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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of brain metastases 2 years after randomization
- Secondary Outcome Measures
Name Time Method Overall survival and disease-free survival 2 years after randomization Quality of life as assessed by Quality of Life Questionnaire (QLQ)-C30/BN20 before randomization, at 6 and 12 months, and annually thereafter 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
Trial Locations
- Locations (93)
Masaryk Memorial Cancer Institute
🇨🇿Brno, Czech Republic
Centre Hospitalier Victor Dupouy
🇫🇷Argenteuil, France
Centre Hospital Regional Universitaire de Limoges
🇫🇷Limoges, France
CHR D'Orleans - Hopital de la Source
🇫🇷Orleans, France
Polyclinique Bordeaux Nord Aquitaine
🇫🇷Boucher, France
Centre Regional Francois Baclesse
🇫🇷Caen, France
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
🇫🇷Dijon, France
Centre Guillaume Le Conquerant
🇫🇷Le Havre, France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
🇫🇷Montpellier, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Institut Curie - Section Medicale
🇫🇷Paris, France
Centre De Radiotherapie Charlebourg
🇫🇷La Garenne Colombes, France
C.R.T.T.
🇫🇷Meudon La Foret, France
C.H. General De Montbelliard
🇫🇷Montbelliard, France
Venizelion Gr.
🇬🇷Heraklion, Greece
University of Patras Medical School
🇬🇷Rio Patras, Greece
Centre du Rouget
🇫🇷Sarcelles, France
Centre Hospitalier Prive Des Yvelines
🇫🇷Sartrouville, France
Evaggelismos Hospital
🇬🇷Athens, Greece
Institute of Oncology
🇵🇱Lodz, Poland
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
🇵🇱Warsaw, Poland
Centre Hospitalier Universitaire Vaudois
🇨ðŸ‡Lausanne, Switzerland
Hopital d'Instruction des Armes Sainte-Anne
🇫🇷Toulon, France
Regional Lung Diseases Hospital
🇵🇱Poznan, Poland
Institute of Oncology and Radiology of Serbia
🇷🇸Belgrade, Serbia
New Cross Hospital
🇬🇧Wolverhampton, England, United Kingdom
Institut Gustave Roussy
🇫🇷Villejuif, France
Tel-Aviv Sourasky Medical Center
🇮🇱Tel-Aviv, Israel
Ospedale Ostetrico Ginecologica Sant Anna
🇮🇹Turin, Italy
Chaim Sheba Medical Center
🇮🇱Tel Hashomer, Israel
Ospedale Bellaria
🇮🇹Bologna, Italy
Osaka National Hospital
🇯🇵Osaka, Japan
Medical University of Gdansk
🇵🇱Gdansk, Poland
Northern Centre for Cancer Treatment at Newcastle General Hospital
🇬🇧Newcastle-Upon-Tyne, England, United Kingdom
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Institute of Oncology at Vilnius University
🇱🇹Vilnius, Lithuania
Nijmegen Cancer Center at Radboud University Medical Center
🇳🇱Nijmegen, Netherlands
Mount Vernon Cancer Centre at Mount Vernon Hospital
🇬🇧Northwood, England, United Kingdom
Nottingham City Hospital NHS Trust
🇬🇧Nottingham, England, United Kingdom
Christie Hospital N.H.S. Trust
🇬🇧Manchester, England, United Kingdom
Marmara University Hospital
🇹🇷Istanbul, Turkey
Western General Hospital
🇬🇧Edinburgh, Scotland, United Kingdom
Raigmore Hospital
🇬🇧Inverness, Scotland, United Kingdom
Nevill Hall Hospital
🇬🇧Gwent, Wales, United Kingdom
Royal Gwent Hospital
🇬🇧Newport Gwent, Wales, United Kingdom
Clinique Sainte Elisabeth
🇧🇪Namur, Belgium
Bank Of Cyprus Oncology Centre
🇨🇾Nicosia, Cyprus
Hopitaux Universitaire de Strasbourg
🇫🇷Strasbourg, France
Centre Medico-Chirurgical Foch
🇫🇷Suresnes, France
Centre d'Oncologie Saint-Yves
🇫🇷Vannes, France
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Cancer Therapy Centre at Campbelltown Hospital
🇦🇺Campbelltown, New South Wales, Australia
Centre Paul Papin
🇫🇷Angers, France
Hopital de Jolimont
🇧🇪Haine Saint Paul, Belgium
Clinique Saint-Joseph
🇧🇪Liege, Belgium
Clinica Renaca - Gocchi
🇨🇱Vina Del Mar, Chile
University Hospital of Heraklion
🇬🇷Heraklion, Crete, Greece
Centre Hospitalier Lyon Sud
🇫🇷Pierre Benite, France
Institut Jean Godinot
🇫🇷Reims, France
Centre Frederic Joliot
🇫🇷Rouen, France
Sotiria Hospital Chest Diseases
🇬🇷Athens, Greece
Universita Degli Studi Di Pisa
🇮🇹Pisa, Italy
Ziekenhuis Netwerk Antwerpen Middelheim
🇧🇪Antwerpen, Belgium
Universiteit Gent
🇧🇪Ghent, Belgium
Centre de Traitement Hautes - Energies
🇫🇷Amiens, France
C.H.G. Beauvais
🇫🇷Beauvais, France
M.D. Anderson Cancer Center at University of Texas
🇺🇸Houston, Texas, United States
CRLCC Nantes - Atlantique
🇫🇷Nantes-Saint Herblain, France
Radiation Oncology Victoria
🇦🇺East Melbourne, Victoria, Australia
Arnhems Radiotherapeutisch Instituut
🇳🇱Arnhem, Netherlands
Hospital Virgen de la Arrixaca
🇪🇸El Palmar, Spain
Institute of Radiotherapy and Oncology
🇲🇰Skopje, Macedonia, The Former Yugoslav Republic of
Hospital Virgen de las Nieves
🇪🇸Granada, Spain
Hospital Santa Maria
🇵🇹Lisbon, Portugal
Groote Schuur Hospital
🇿🇦Cape Town, South Africa
Velindre Cancer Center at Velinde Hospital
🇬🇧Cardiff, United Kingdom
Cancer Research Centre at Weston Park Hospital
🇬🇧Sheffield, United Kingdom
Instituto Nacional de Cancer
🇧🇷Copacabana, Rio de Janeiro, Brazil
Cazk Groeninghe - Campus Maria's Voorzienigheid
🇧🇪Kortrijk, Belgium
Instituto de Radiomedicina
🇨🇱Santiago, Chile
Rui Jin Hospital
🇨🇳Shanghai, China
First Medical Clinic of Charles University Hospital
🇨🇿Prague, Czech Republic
Clinique De Rochebelle
🇫🇷Ales, France
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
Centre de Radiotherapie
🇫🇷Compiegne, France
Centre Hospitalier Sud Francilien - Site Corbeil
🇫🇷Corbeil, France
Centre Hospitalier Universitaire Henri Mondor
🇫🇷Creteil, France
Hopital Intercommunal De Creteil
🇫🇷Creteil, France
Akademisch Ziekenhuis Vrije Universiteit - Medisch Centrum
🇳🇱Amsterdam, Netherlands
University Medical Center Rotterdam at Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
Institutul Oncologic - Universitatea de Medicina
🇷🇴Cluj-Napoca, Romania
Beatson Oncology Centre
🇬🇧Glasgow, Scotland, United Kingdom
Hospital Militar Central
🇨🇴Bogota, Colombia