Radiation Therapy to Prevent Brain Metastases in Patients With Previously Treated Extensive-Stage Small Cell Lung Cancer
NCT ID: NCT00016211
Last Updated: 2012-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
287 participants
INTERVENTIONAL
2001-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy in preventing brain metastases in patients who have received chemotherapy for extensive-stage small cell lung cancer.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Compare the incidence of, and time to, symptomatic brain metastases in patients with previously treated extensive stage small cell lung cancer treated with prophylactic cranial irradiation vs no further therapy.
* Compare the quality of life and survival of these patients.
* Determine the toxicity of this regimen in these patients.
* Determine the health economics associated with this study.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and performance status. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Within 5 weeks after completion of prior chemotherapy, patients undergo prophylactic cranial irradiation once daily for 5-12 days.
* Arm II: Patients receive no further therapy after completion of prior chemotherapy.
Quality of life is assessed at baseline, 6 weeks, every 3 months for 1 year, and then every 6 months thereafter.
Patients are followed at 6 weeks, every 3 months for 1 year, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 287 patients will be accrued for this study within 3 years.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
TREATMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
radiation therapy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Cytologically or histologically confirmed small cell lung cancer
* Documented extensive disease before the initiation of chemotherapy
* Responsive disease after 4 to 6 courses of initial chemotherapy
* No more than 5 weeks since completion of prior chemotherapy
* No brain or leptomeningeal metastases
PATIENT CHARACTERISTICS:
Age:
* 18 to 75
Performance status:
* WHO 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* No other prior or concurrent malignancy except skin cancer or carcinoma in situ of the cervix
* No psychological, familial, sociological, or geographical condition that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
Endocrine therapy:
* No concurrent corticosteroids
Radiotherapy:
* No prior radiotherapy to the brain
* No prior radiotherapy to the head and neck
Surgery:
* Not specified
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
B.J. Slotman, PhD, MD
Role: STUDY_CHAIR
Free University Medical Center
Pieter E. Postmus, MD
Role: STUDY_CHAIR
Free University Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ziekenhuis Netwerk Antwerpen Middelheim
Antwerp, , Belgium
Universiteit Gent
Ghent, , Belgium
Hopital de Jolimont
Haine-Saint-Paul, , Belgium
Cazk Groeninghe - Campus Maria's Voorzienigheid
Kortrijk, , Belgium
Centre Hospitalier Regional de la Citadelle
Liège, , Belgium
Clinique Saint-Joseph
Liège, , Belgium
Bank Of Cyprus Oncology Centre
Nicosia, , Cyprus
National Cancer Institute of Egypt
Cairo, , Egypt
Institut Gustave Roussy
Villejuif, , France
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, , Germany
University of Kaposvar
Kaposvár, , Hungary
Rambam Medical Center
Haifa, , Israel
Ospedale Santa Croce
Cuneo, , Italy
Istituto Nazionale per la Ricerca sul Cancro
Genoa (Genova), , Italy
Azienda Ospedaliera Di Parma
Parma, , Italy
Vrije Universiteit Medisch Centrum
Amsterdam, , Netherlands
Academisch Medisch Centrum at University of Amsterdam
Amsterdam, , Netherlands
Arnhems Radiotherapeutisch Instituut
Arnhem, , Netherlands
Radiotherapeutisch Instituut-(Riso)
Deventer, , Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Radiotherapeutisch Instituut Friesland
Leeuwarden, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Nijmegen Cancer Center at Radboud University Medical Center
Nijmegen, , Netherlands
University Medical Center Rotterdam at Erasmus Medical Center
Rotterdam, , Netherlands
Erasmus MC - Sophia Children's Hospital
Rotterdam, , Netherlands
Dr. Bernard Verbeeten Instituut
Tilburg, , Netherlands
Medical University of Gdansk
Gdansk, , Poland
Marmara University Hospital
Istanbul, , Turkey (Türkiye)
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom
Princess Royal Hospital
Hull, England, United Kingdom
Cookridge Hospital at Leeds Teaching Hospital NHS Trust
Leeds, England, United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom
Christie Hospital N.H.S. Trust
Manchester, England, United Kingdom
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle upon Tyne, England, 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, England, United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, England, United Kingdom
Southampton General Hospital
Southampton, England, United Kingdom
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom
Southend NHS Trust Hospital
Westcliff-on-Sea, England, United Kingdom
Ninewells Hospital and Medical School
Dundee, Scotland, United Kingdom
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, United Kingdom
Western Infirmary
Glasgow, Scotland, United Kingdom
Raigmore Hospital
Inverness, Scotland, United Kingdom
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, United Kingdom
Nevill Hall Hospital
Gwent, Wales, United Kingdom
Royal Gwent Hospital
Newport Gwent, Wales, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Slotman BJ, Mauer ME, Bottomley A, Faivre-Finn C, Kramer GW, Rankin EM, Snee M, Hatton M, Postmus PE, Collette L, Senan S. Prophylactic cranial irradiation in extensive disease small-cell lung cancer: short-term health-related quality of life and patient reported symptoms: results of an international Phase III randomized controlled trial by the EORTC Radiation Oncology and Lung Cancer Groups. J Clin Oncol. 2009 Jan 1;27(1):78-84. doi: 10.1200/JCO.2008.17.0746. Epub 2008 Dec 1.
Slotman B, Faivre-Finn C, Kramer G, et al.: A randomized trial of prophylactic cranial irradiation (PCI) versus no PCI in extensive disease small cell lung cancer after a response to chemotherapy (EORTC 08993-22993). [Abstract] J Clin Oncol 25 (Suppl 18): A-4, 2s, 2007.
Slotman B, Faivre-Finn C, Kramer G, Rankin E, Snee M, Hatton M, Postmus P, Collette L, Musat E, Senan S; EORTC Radiation Oncology Group and Lung Cancer Group. Prophylactic cranial irradiation in extensive small-cell lung cancer. N Engl J Med. 2007 Aug 16;357(7):664-72. doi: 10.1056/NEJMoa071780.
Slotman BJ, Faivre-Finn C, Kramer GWPM, et al.: Prophylactic cranial irradiation (PCI) in extensive stage small cell lung cancer (ES-SCLC) (EORTC 22993-08993). [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-7, S4, 2007.
Bernhardt D, Adeberg S, Bozorgmehr F, Opfermann N, Hoerner-Rieber J, Repka MC, Kappes J, Thomas M, Bischoff H, Herth F, Heussel CP, Debus J, Steins M, Rieken S. Nine-year Experience: Prophylactic Cranial Irradiation in Extensive Disease Small-cell Lung Cancer. Clin Lung Cancer. 2017 Jul;18(4):e267-e271. doi: 10.1016/j.cllc.2016.11.012. Epub 2016 Dec 2.
Slotman BJ, Faivre-Finn C, Kramer GW, Rankin E, Snee M, Hatton M, Postmus PE, Collette L, Musat E, Senan S. [Prophylactic cranial irradiation in patients with extensive disease caused by small-cell lung cancer responsive to chemotherapy: fewer symptomatic brain metastases and improved survival]. Ned Tijdschr Geneeskd. 2008 Apr 26;152(17):1000-4. Dutch.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EORTC-RA-22993
Identifier Type: -
Identifier Source: secondary_id
EORTC-LCG-08993
Identifier Type: -
Identifier Source: secondary_id
EORTC-22993-08993
Identifier Type: -
Identifier Source: org_study_id