Radiation Therapy to Prevent Brain Metastases in Patients With Previously Treated Extensive-Stage Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00016211
- Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy to the brain may be effective in preventing brain metastases. It is not yet known if radiation therapy is effective following chemotherapy in preventing brain metastases.
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
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 287
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to symptomatic brain metastases measured by Logrank at 6 weeks, every 3 months in year 1, and then every 6 months
- Secondary Outcome Measures
Name Time Method Quality of life assessed by EORTC QLQ-C30 and EORTC BN-20 at baseline, 6 weeks, every 3 months in year 1, and then every 6 months Toxicity assessed by NCI CTC v2.0 during treatment, at 6 weeks, every 3 months in year 1, and then every 6 months Survival measured by Logrank at 6 weeks, every 3 months in year 1, and then every 6 months
Trial Locations
- Locations (49)
University of Kaposvar
ðŸ‡ðŸ‡ºKaposvar, Hungary
Cancer Research Centre at Weston Park Hospital
🇬🇧Sheffield, England, United Kingdom
Ziekenhuis Netwerk Antwerpen Middelheim
🇧🇪Antwerp, Belgium
Cazk Groeninghe - Campus Maria's Voorzienigheid
🇧🇪Kortrijk, Belgium
Hopital de Jolimont
🇧🇪Haine Saint Paul, Belgium
Universiteit Gent
🇧🇪Ghent, Belgium
National Cancer Institute of Egypt
🇪🇬Cairo, Egypt
Centre Hospitalier Regional de la Citadelle
🇧🇪Liege, Belgium
Clinique Saint-Joseph
🇧🇪Liege, Belgium
Institut Gustave Roussy
🇫🇷Villejuif, France
Universitaetsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Ospedale Santa Croce
🇮🇹Cuneo, Italy
Rambam Medical Center
🇮🇱Haifa, Israel
Istituto Nazionale per la Ricerca sul Cancro
🇮🇹Genoa (Genova), Italy
Vrije Universiteit Medisch Centrum
🇳🇱Amsterdam, Netherlands
Arnhems Radiotherapeutisch Instituut
🇳🇱Arnhem, Netherlands
Azienda Ospedaliera Di Parma
🇮🇹Parma, Italy
Radiotherapeutisch Instituut-(Riso)
🇳🇱Deventer, Netherlands
Academisch Medisch Centrum at University of Amsterdam
🇳🇱Amsterdam, Netherlands
Radiotherapeutisch Instituut Friesland
🇳🇱Leeuwarden, Netherlands
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Leiden University Medical Center
🇳🇱Leiden, Netherlands
University Medical Center Rotterdam at Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
Nijmegen Cancer Center at Radboud University Medical Center
🇳🇱Nijmegen, Netherlands
Medical University of Gdansk
🇵🇱Gdansk, Poland
Dr. Bernard Verbeeten Instituut
🇳🇱Tilburg, Netherlands
Erasmus MC - Sophia Children's Hospital
🇳🇱Rotterdam, Netherlands
Marmara University Hospital
🇹🇷Istanbul, Turkey
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
Mount Vernon Cancer Centre at Mount Vernon Hospital
🇬🇧Northwood, England, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital
🇬🇧Newcastle Upon Tyne, England, United Kingdom
Nottingham City Hospital NHS Trust
🇬🇧Nottingham, 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
Western Infirmary
🇬🇧Glasgow, Scotland, United Kingdom
Nevill Hall Hospital
🇬🇧Gwent, Wales, United Kingdom
Royal Gwent Hospital
🇬🇧Newport Gwent, Wales, United Kingdom
Raigmore Hospital
🇬🇧Inverness, Scotland, United Kingdom
Bank Of Cyprus Oncology Centre
🇨🇾Nicosia, Cyprus
Edinburgh Cancer Centre at Western General Hospital
🇬🇧Edinburgh, Scotland, United Kingdom
Bristol Haematology and Oncology Centre
🇬🇧Bristol, England, United Kingdom
Velindre Cancer Center at Velindre Hospital
🇬🇧Cardiff, Wales, United Kingdom