Radiation Therapy in Patients With Limited-Stage Small Cell Lung Cancer in Complete Remission
Recruitment status was Active, not recruiting
|First Received Date ICMJE||April 6, 2000|
|Last Updated Date||January 15, 2011|
|Start Date ICMJE||September 1999|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Incidence of brain metastases 2 years after randomization [ Designated as safety issue: No ]|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00005062 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Radiation Therapy in Patients With Limited-Stage Small Cell Lung Cancer in Complete Remission|
|Official Title ICMJE||A Phase III Trial Comparing High Versus Standard Dose of Prophylactic Cranial Irradiation (PCI) in Limited Small Cell Lung Cancer Complete Responders|
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.
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.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Primary Purpose: Treatment
|Condition ICMJE||Lung Cancer|
|Intervention ICMJE||Radiation: radiation therapy|
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Enrollment ICMJE||Not Provided|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
PRIOR CONCURRENT THERAPY:
|Ages||up to 70 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||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|
|NCT Number ICMJE||NCT00005062|
|Other Study ID Numbers ICMJE||CDR0000067664, FRE-IGR-PCI-99, EU-99051, FRE-IFCT-99.01, FRE-IGR-PCI99-EULINT1, EORTC-22003, EORTC-08004|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Institut Gustave Roussy|
|Collaborators ICMJE||European Organisation for Research and Treatment of Cancer - EORTC|
|Information Provided By||National Cancer Institute (NCI)|
|Verification Date||January 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP