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

Lung Cancer Clinical Trial

Official title:

A Phase III Trial Comparing High Versus Standard Dose of Prophylactic Cranial Irradiation (PCI) in Limited Small Cell Lung Cancer Complete Responders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005062
• Other study ID #: CDR0000067664
• Secondary ID: FRE-IGR-PCI-99EU
• Status: Completed
• Phase: Phase 3
• First received: April 6, 2000
• Last updated: March 12, 2014
• Start date: September 1999
• Est. completion date: December 2005

Study information

• Verified date: March 2014
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Australia	Cancer Therapy Centre at Campbelltown Hospital	Campbelltown	New South Wales
Australia	Radiation Oncology Victoria	East Melbourne	Victoria
Belgium	Ziekenhuis Netwerk Antwerpen Middelheim	Antwerpen
Belgium	Universiteit Gent	Ghent
Belgium	Hopital de Jolimont	Haine Saint Paul
Belgium	Cazk Groeninghe - Campus Maria's Voorzienigheid	Kortrijk
Belgium	Clinique Saint-Joseph	Liege
Belgium	Clinique Sainte Elisabeth	Namur
Brazil	Instituto Nacional de Cancer	Copacabana	Rio de Janeiro
Chile	Instituto de Radiomedicina	Santiago
Chile	Clinica Renaca - Gocchi	Vina Del Mar
China	Rui Jin Hospital	Shanghai
Colombia	Hospital Militar Central	Bogota
Cyprus	Bank Of Cyprus Oncology Centre	Nicosia
Czech Republic	Masaryk Memorial Cancer Institute	Brno
Czech Republic	First Medical Clinic of Charles University Hospital	Prague
France	Clinique De Rochebelle	Ales
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	Compiegne
France	Centre Hospitalier Sud Francilien - Site Corbeil	Corbeil
France	Centre Hospitalier Universitaire Henri Mondor	Creteil
France	Hopital Intercommunal De Creteil	Creteil
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 Foret
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	Orleans
France	Institut Curie - Section Medicale	Paris
France	Centre Hospitalier Lyon Sud	Pierre Benite
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
Germany	Universitaetsklinikum Essen	Essen
Greece	Evaggelismos Hospital	Athens
Greece	Sotiria Hospital Chest Diseases	Athens
Greece	University Hospital of Heraklion	Heraklion	Crete
Greece	Venizelion Gr.	Heraklion
Greece	University of Patras Medical School	Rio Patras
Israel	Chaim Sheba Medical Center	Tel Hashomer
Israel	Tel-Aviv Sourasky Medical Center	Tel-Aviv
Italy	Ospedale Bellaria	Bologna
Italy	Universita Degli Studi Di Pisa	Pisa
Italy	Ospedale Ostetrico Ginecologica Sant Anna	Turin
Japan	Osaka National Hospital	Osaka
Korea, Republic of	Samsung Medical Center	Seoul
Lithuania	Institute of Oncology at Vilnius University	Vilnius
Macedonia, The Former Yugoslav R	Institute of Radiotherapy and Oncology	Skopje
Netherlands	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
Poland	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
Portugal	Hospital Santa Maria	Lisbon
Romania	Institutul Oncologic - Universitatea de Medicina	Cluj-Napoca
Serbia	Institute of Oncology and Radiology of Serbia	Belgrade
South Africa	Groote Schuur Hospital	Cape Town
Spain	Hospital Virgen de la Arrixaca	El Palmar
Spain	Hospital Virgen de las Nieves	Granada
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
Turkey	Marmara University Hospital	Istanbul
United Kingdom	Velindre Cancer Center at Velinde Hospital	Cardiff
United Kingdom	Western General Hospital	Edinburgh	Scotland
United Kingdom	Beatson Oncology Centre	Glasgow	Scotland
United Kingdom	Nevill Hall Hospital	Gwent	Wales
United Kingdom	Raigmore Hospital	Inverness	Scotland
United Kingdom	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	Royal Gwent Hospital	Newport Gwent	Wales
United Kingdom	Mount Vernon Cancer Centre at Mount Vernon Hospital	Northwood	England
United Kingdom	Nottingham City Hospital NHS Trust	Nottingham	England
United Kingdom	Cancer Research Centre at Weston Park Hospital	Sheffield
United Kingdom	New Cross Hospital	Wolverhampton	England
United States	M.D. Anderson Cancer Center at University of Texas	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris	European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Chile,  China,  Colombia,  Cyprus,  Czech Republic,  France,  Germany,  Greece,  Israel,  Italy,  Japan,  Korea, Republic of,  Lithuania,  Macedonia, The Former Yugoslav Republic of,  Netherlands,  Poland,  Portugal,  Romania,  Serbia,  South Africa,  Spain,  Switzerland,  Turkey,  United Kingdom, 

References & Publications (3)

Le Péchoux 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. — View Citation

Le Péchoux 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 outcom — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of brain metastases 2 years after randomization			No
Secondary	Overall survival and disease-free survival 2 years after randomization			No
Secondary	Quality of life as assessed by Quality of Life Questionnaire (QLQ)-C30/BN20 before randomization, at 6 and 12 months, and annually thereafter			No
Secondary	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			No