Radiation Therapy in Patients With Limited-Stage Small Cell Lung Cancer in Complete Remission

This study has been completed.
Sponsor:
Collaborator:
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT00005062
First received: April 6, 2000
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Phase III Trial Comparing High Versus Standard Dose of Prophylactic Cranial Irradiation (PCI) in Limited Small Cell Lung Cancer Complete Responders

Resource links provided by NLM:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • Incidence of brain metastases 2 years after randomization [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival and disease-free survival 2 years after randomization [ Designated as safety issue: No ]
  • Quality of life as assessed by Quality of Life Questionnaire (QLQ)-C30/BN20 before randomization, at 6 and 12 months, and annually thereafter [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]

Study Start Date: September 1999
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005062

  Hide Study Locations
Locations
United States, Texas
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Australia, New South Wales
Cancer Therapy Centre at Campbelltown Hospital
Campbelltown, New South Wales, Australia, 2560
Australia, Victoria
Radiation Oncology Victoria
East Melbourne, Victoria, Australia, 3002
Belgium
Ziekenhuis Netwerk Antwerpen Middelheim
Antwerpen, Belgium, 2020
Universiteit Gent
Ghent, Belgium, B-9000
Hopital de Jolimont
Haine Saint Paul, Belgium, 7100
Cazk Groeninghe - Campus Maria's Voorzienigheid
Kortrijk, Belgium, B-8500
Clinique Saint-Joseph
Liege, Belgium, B 4000
Clinique Sainte Elisabeth
Namur, Belgium, 50000
Brazil
Instituto Nacional de Cancer
Copacabana, Rio de Janeiro, Brazil, CEP 22040-010
Chile
Instituto de Radiomedicina
Santiago, Chile, 10
Clinica Renaca - Gocchi
Vina Del Mar, Chile
China
Rui Jin Hospital
Shanghai, China, 200025
Colombia
Hospital Militar Central
Bogota, Colombia
Cyprus
Bank Of Cyprus Oncology Centre
Nicosia, Cyprus, 2006 Strovolos
Czech Republic
Masaryk Memorial Cancer Institute
Brno, Czech Republic, 656 53
First Medical Clinic of Charles University Hospital
Prague, Czech Republic, 128 08
France
Clinique De Rochebelle
Ales, France, F-30100
Centre de Traitement Hautes - Energies
Amiens, France, 80000
Centre Paul Papin
Angers, France, 49036
Centre Hospitalier Victor Dupouy
Argenteuil, France, 95107
C.H.G. Beauvais
Beauvais, France, 60000
Polyclinique Bordeaux Nord Aquitaine
Boucher, France, 33300
Centre Regional Francois Baclesse
Caen, France, 14076
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Centre de Radiotherapie
Compiegne, France, 60200
Centre Hospitalier Sud Francilien - Site Corbeil
Corbeil, France, 91100
Hopital Intercommunal De Creteil
Creteil, France, 94010
Centre Hospitalier Universitaire Henri Mondor
Creteil, France, 94010
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, France, 21079
Centre De Radiotherapie Charlebourg
La Garenne Colombes, France, 92250
Centre Guillaume Le Conquerant
Le Havre, France, 76600
Centre Hospital Regional Universitaire de Limoges
Limoges, France, 87042
C.R.T.T.
Meudon La Foret, France, 92360
C.H. General De Montbelliard
Montbelliard, France, 25200
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, France, 44805
Centre Antoine Lacassagne
Nice, France, 06189
CHR D'Orleans - Hopital de la Source
Orleans, France, 45067
Institut Curie - Section Medicale
Paris, France, 75005
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69495
Institut Jean Godinot
Reims, France, 51056
Centre Frederic Joliot
Rouen, France, 76000
Centre du Rouget
Sarcelles, France, 95250
Centre Hospitalier Prive Des Yvelines
Sartrouville, France, 78500
Hopitaux Universitaire de Strasbourg
Strasbourg, France, 67100
Centre Medico-Chirurgical Foch
Suresnes, France, 92151
Hopital d'Instruction des Armes Sainte-Anne
Toulon, France, 83800
Centre d'Oncologie Saint-Yves
Vannes, France, 56001
Institut Gustave Roussy
Villejuif, France, F-94805
Germany
Universitaetsklinikum Essen
Essen, Germany, D-45122
Greece
University Hospital of Heraklion
Heraklion, Crete, Greece, 71110
Evaggelismos Hospital
Athens, Greece, 10676
Sotiria Hospital Chest Diseases
Athens, Greece
Venizelion Gr.
Heraklion, Greece, 71306
University of Patras Medical School
Rio Patras, Greece, GR-26500
Israel
Chaim Sheba Medical Center
Tel Hashomer, Israel, 52621
Tel-Aviv Sourasky Medical Center
Tel-Aviv, Israel, 64239
Italy
Ospedale Bellaria
Bologna, Italy, I-40139
Universita Degli Studi Di Pisa
Pisa, Italy, 56126
Ospedale Ostetrico Ginecologica Sant Anna
Turin, Italy, 10126
Japan
Osaka National Hospital
Osaka, Japan, 540-0006
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Lithuania
Institute of Oncology at Vilnius University
Vilnius, Lithuania, 08660
Macedonia, The Former Yugoslav Republic of
Institute of Radiotherapy and Oncology
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Netherlands
Akademisch Ziekenhuis Vrije Universiteit - Medisch Centrum
Amsterdam, Netherlands, 1007 MB
Arnhems Radiotherapeutisch Instituut
Arnhem, Netherlands, 6815 AD
Nijmegen Cancer Center at Radboud University Medical Center
Nijmegen, Netherlands, 6500 HB
University Medical Center Rotterdam at Erasmus Medical Center
Rotterdam, Netherlands, 3000 CA
Poland
Medical University of Gdansk
Gdansk, Poland, 80 211
Institute of Oncology
Lodz, Poland, 93509
Regional Lung Diseases Hospital
Poznan, Poland, 60 569
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, Poland, 02 781
Portugal
Hospital Santa Maria
Lisbon, Portugal, 1649-035
Romania
Institutul Oncologic - Universitatea de Medicina
Cluj-Napoca, Romania, 3400
Serbia
Institute of Oncology and Radiology of Serbia
Belgrade, Serbia, 11000
South Africa
Groote Schuur Hospital
Cape Town, South Africa, 7925
Spain
Hospital Virgen de la Arrixaca
El Palmar, Spain, 30120
Hospital Virgen de las Nieves
Granada, Spain, 18014
Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
Turkey
Marmara University Hospital
Istanbul, Turkey, 81190
United Kingdom
Christie Hospital N.H.S. Trust
Manchester, England, United Kingdom, M20 4BX
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom, HA6 2RN
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom, NG5 1PB
New Cross Hospital
Wolverhampton, England, United Kingdom, WV10 0QP
Western General Hospital
Edinburgh, Scotland, United Kingdom, EH4 2XU
Beatson Oncology Centre
Glasgow, Scotland, United Kingdom, G11 6NT
Raigmore Hospital
Inverness, Scotland, United Kingdom, 1V2 3UJ
Nevill Hall Hospital
Gwent, Wales, United Kingdom
Royal Gwent Hospital
Newport Gwent, Wales, United Kingdom, NP9 2UB
Velindre Cancer Center at Velinde Hospital
Cardiff, United Kingdom, CF4 7XL
Cancer Research Centre at Weston Park Hospital
Sheffield, United Kingdom, S10 2SJ
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Investigator: Cecile Le Pechoux, MD Gustave Roussy, Cancer Campus, Grand Paris
Investigator: Suresh Senan Free University Medical Center
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00005062     History of Changes
Other Study ID Numbers: CDR0000067664, FRE-IGR-PCI-99, EU-99051, FRE-IFCT-99.01, FRE-IGR-PCI99-EULINT1, EORTC-22003, EORTC-08004
Study First Received: April 6, 2000
Last Updated: March 12, 2014
Health Authority: United States: Federal Government

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
limited stage small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on September 30, 2014