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

NCT00005062 | Completed Phase 3

• 7 other identifiers: CDR0000067664FRE-IGR-PCI-99EU-99051FRE-IFCT-99.01FRE-IGR-PCI99-EULINT1EORTC-22003EORTC-08004
• Study Type: interventional
• Target: N/A
• Locations: 28 countries
• Sites: 93

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.

Conditions

Lung Cancer

Keywords

limited stage small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of brain metastases 2 years after randomization

Secondary Outcomes (3)

• 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

Interventions

radiation therapy RADIATION

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead
• European Organisation for Research and Treatment of Cancer - EORTC: collaborator

Study Sites (93)

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Cancer Therapy Centre at Campbelltown Hospital

Campbelltown, New South Wales, 2560, Australia

Location

Radiation Oncology Victoria

East Melbourne, Victoria, 3002, Australia

Location

Ziekenhuis Netwerk Antwerpen Middelheim

Antwerp, 2020, Belgium

Location

Universiteit Gent

Ghent, B-9000, Belgium

Location

Hopital de Jolimont

Haine-Saint-Paul, 7100, Belgium

Location

Cazk Groeninghe - Campus Maria's Voorzienigheid

Kortrijk, B-8500, Belgium

Location

Clinique Saint-Joseph

Liège, B 4000, Belgium

Location

Clinique Sainte Elisabeth

Namur, 50000, Belgium

Location

Instituto Nacional de Cancer

Copacabana, Rio de Janeiro, CEP 22040-010, Brazil

Location

Instituto de Radiomedicina

Santiago, 10, Chile

Location

Clinica Renaca - Gocchi

Viña del Mar, Chile

Location

Rui Jin Hospital

Shanghai, 200025, China

Location

Hospital Militar Central

Bogotá, Colombia

Location

Bank Of Cyprus Oncology Centre

Nicosia, 2006 Strovolos, Cyprus

Location

Masaryk Memorial Cancer Institute

Brno, 656 53, Czechia

Location

First Medical Clinic of Charles University Hospital

Prague, 128 08, Czechia

Location

Clinique De Rochebelle

Alès, F-30100, France

Location

Centre de Traitement Hautes - Energies

Amiens, 80000, France

Location

Centre Paul Papin

Angers, 49036, France

Location

Centre Hospitalier Victor Dupouy

Argenteuil, 95107, France

Location

C.H.G. Beauvais

Beauvais, 60000, France

Location

Polyclinique Bordeaux Nord Aquitaine

Boucher, 33300, France

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Centre de Radiotherapie

Compiègne, 60200, France

Location

Centre Hospitalier Sud Francilien - Site Corbeil

Corbeil, 91100, France

Location

Centre Hospitalier Universitaire Henri Mondor

Créteil, 94010, France

Location

Hopital Intercommunal De Creteil

Créteil, 94010, France

Location

Centre de Lutte Contre le Cancer Georges-Francois Leclerc

Dijon, 21079, France

Location

Centre De Radiotherapie Charlebourg

La Garenne-Colombes, 92250, France

Location

Centre Guillaume Le Conquerant

Le Havre, 76600, France

Location

Centre Hospital Regional Universitaire de Limoges

Limoges, 87042, France

Location

C.R.T.T.

Meudon-la-Forêt, 92360, France

Location

C.H. General De Montbelliard

Montbelliard, 25200, France

Location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

CRLCC Nantes - Atlantique

Nantes-Saint Herblain, 44805, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

CHR D'Orleans - Hopital de la Source

Orléans, 45067, France

Location

Institut Curie - Section Medicale

Paris, 75005, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

Centre Frederic Joliot

Rouen, 76000, France

Location

Centre du Rouget

Sarcelles, 95250, France

Location

Centre Hospitalier Prive Des Yvelines

Sartrouville, 78500, France

Location

Hopitaux Universitaire de Strasbourg

Strasbourg, 67100, France

Location

Centre Medico-Chirurgical Foch

Suresnes, 92151, France

Location

Hopital d'Instruction des Armes Sainte-Anne

Toulon, 83800, France

Location

Centre d'Oncologie Saint-Yves

Vannes, 56001, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Universitaetsklinikum Essen

Essen, D-45122, Germany

Location

University Hospital of Heraklion

Heraklion, Crete, 71110, Greece

Location

Evaggelismos Hospital

Athens, 10676, Greece

Location

Sotiria Hospital Chest Diseases

Athens, Greece

Location

Venizelion Gr.

Heraklion, 71306, Greece

Location

University of Patras Medical School

Rio Patras, GR-26500, Greece

Location

Tel-Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

Ospedale Bellaria

Bologna, I-40139, Italy

Location

Universita Degli Studi Di Pisa

Pisa, 56126, Italy

Location

Ospedale Ostetrico Ginecologica Sant Anna

Turin, 10126, Italy

Location

Osaka National Hospital

Osaka, 540-0006, Japan

Location

Institute of Oncology at Vilnius University

Vilnius, 08660, Lithuania

Location

Akademisch Ziekenhuis Vrije Universiteit - Medisch Centrum

Amsterdam, 1007 MB, Netherlands

Location

Arnhems Radiotherapeutisch Instituut

Arnhem, 6815 AD, Netherlands

Location

Nijmegen Cancer Center at Radboud University Medical Center

Nijmegen, 6500 HB, Netherlands

Location

University Medical Center Rotterdam at Erasmus Medical Center

Rotterdam, 3000 CA, Netherlands

Location

Institute of Radiotherapy and Oncology

Skopje, 1000, North Macedonia

Location

Medical University of Gdansk

Gdansk, 80 211, Poland

Location

Institute of Oncology

Lodz, 93509, Poland

Location

Regional Lung Diseases Hospital

Poznan, 60 569, Poland

Location

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

Warsaw, 02 781, Poland

Location

Hospital Santa Maria

Lisbon, 1649-035, Portugal

Location

Institutul Oncologic - Universitatea de Medicina

Cluj-Napoca, 3400, Romania

Location

Institute of Oncology and Radiology of Serbia

Belgrade, 11000, Serbia

Location

Groote Schuur Hospital

Cape Town, 7925, South Africa

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Hospital Virgen de la Arrixaca

El Palmar, 30120, Spain

Location

Hospital Virgen de las Nieves

Granada, 18014, Spain

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Marmara University Hospital

Istanbul, 81190, Turkey (Türkiye)

Location

Christie Hospital N.H.S. Trust

Manchester, England, M20 4BX, United Kingdom

Location

Northern Centre for Cancer Treatment at Newcastle General Hospital

Newcastle upon Tyne, England, NE4 6BE, United Kingdom

Location

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

Nottingham City Hospital NHS Trust

Nottingham, England, NG5 1PB, United Kingdom

Location

New Cross Hospital

Wolverhampton, England, WV10 0QP, United Kingdom

Location

Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Beatson Oncology Centre

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Raigmore Hospital

Inverness, Scotland, 1V2 3UJ, United Kingdom

Location

Nevill Hall Hospital

Gwent, Wales, United Kingdom

Location

Royal Gwent Hospital

Newport Gwent, Wales, NP9 2UB, United Kingdom

Location

Velindre Cancer Center at Velinde Hospital

Cardiff, CF4 7XL, United Kingdom

Location

Cancer Research Centre at Weston Park Hospital

Sheffield, S10 2SJ, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 19386548 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 21139020 RESULT

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Cecile Le Pechoux, MD

  Gustave Roussy, Cancer Campus, Grand Paris

• Suresh Senan

  Free University Medical Center

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 6, 2000
• First Posted: January 27, 2003
• Study Start: September 1, 1999
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: March 13, 2014

Record last verified: 2014-03

Locations

JP (1); PL (4); PT (1); RO (1); ZA (1); CO (1); CN (1); CZ (2); CY (1); GR (5); IL (2); LI (1); ES (2); DE (1); CH (1); BR (1); NL (4); KR (1); TU (1); BE (6); NO (1); CL (2); AU (2); SE (1); GB (12); US (1); IT (3); FR (33)