Radiation Therapy in Patients With Limited-Stage Small Cell Lung Cancer in Complete Remission
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Institut Gustave Roussy
Collaborator:
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005062
First received: April 6, 2000
Last updated: January 15, 2011
Last verified: January 2006
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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 National Cancer Institute (NCI):
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 |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005062
Hide Study Locations
Hide Study LocationsLocations
| 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
Institut Gustave Roussy
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
| Investigator: | Cecile Le Pechoux, MD | Institut Gustave Roussy |
| Investigator: | Suresh Senan | Free University Medical Center |
More Information
Additional Information:
Publications:
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.
| 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: | January 15, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 May 16, 2013