Clinical trial NCT00005062: Radiation Therapy in Patients With Limited-Stage Small Cell Lung Cancer in Complete Remission
Official title: A Phase III Trial Comparing High Versus Standard Dose of Prophylactic Cranial Irradiation (PCI) in Limited Small Cell Lung Cancer Complete Responders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Cancer
Keywords: limited stage small cell lung cancer
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
Collaborators: name: European Organisation for Research and Treatment of Cancer - EORTC
First posted: 2003-01-27
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

Eligibility 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

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