Brain Irradiation in Treating Patients With Limited-Stage Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00057746|
Recruitment Status : Completed
First Posted : April 9, 2003
Results First Posted : May 25, 2016
Last Update Posted : May 25, 2016
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which radiation therapy regimen is more effective in preventing brain metastases in patients with limited-stage small cell lung cancer while taking into account chronic neurotoxicity from radiation therapy.
PURPOSE: This randomized phase II trial compares the incidence of chronic neurotoxicity between three different brain irradiation regimens. The corresponding phase III component addressing the prevention of brain metastases was run by EORTC and reported separately (NCT00005062).
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Radiation: Prophylactic cranial irradiation, 2.5 Gy fx Radiation: Prophylactic cranial irradiation, 2.0 Gy fx Radiation: Prophylactic cranial irradiation, 1.5 Gy fx||Phase 2|
- Compare the incidence of chronic neurotoxicity in patients treated with these regimens.
- Compare quality of life of patients treated with these regimens. (phase III closed to accrual as of 12/31/05)
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (60 and under vs over 60) and time since induction therapy (90 days or less vs 91-180 days vs 181-240 days). Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients undergo prophylactic cranial irradiation (PCI) once daily 5 days a week. Treatment continues for 2 weeks in the absence of unacceptable toxicity.
- Arm II: Patients undergo PCI once daily 5 days a week. Treatment continues for 2.6 weeks in the absence of unacceptable toxicity.
- Arm III: Patients undergo PCI twice daily 5 days a week. Treatment continues for 3.4 weeks in the absence of unacceptable toxicity.
Quality of life is assessed at baseline, every 6 months for 1 year, and then annually for 3 years.
Patients are followed every 6 months for 1 year and then annually for 3 years.
PROJECTED ACCRUAL: A total of 264 patients will be accrued for this study within 3.5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||265 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Randomized Trial Of Two Dose Schedules For Delivering Prophylactic Cranial Irradiation For Patients With Limited Disease Small Cell Lung Cancer|
|Study Start Date :||February 2003|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||November 2013|
Active Comparator: Arm I
Prophylactic cranial irradiation, 2.5 Gy fx
Radiation: Prophylactic cranial irradiation, 2.5 Gy fx
Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions (fx) for a total of 25 Gy
Other Name: PCI
Experimental: Arm II
Prophylactic cranial irradiation, 2.0 Gy fx
Radiation: Prophylactic cranial irradiation, 2.0 Gy fx
Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions (fx) for a total of 36 Gy
Other Name: PCI
Experimental: Arm III
Prophylactic cranial irradiation, 1.5 Gy fx
Radiation: Prophylactic cranial irradiation, 1.5 Gy fx
Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions (fx) for a total dose of 36 Gy
Other Name: PCI
- Incidence of Chronic Neurotoxicity [ Time Frame: From study registration to one year. ]Chronic neurotoxicity is defined as a drop in one standard error of measurement (SEM) in any one of the three tests comprising the neuropsychological test battery (Hopkins Verbal Learning Test, Controlled Word Association Test, and Trail-Making Test) without development of brain metastasis by one year. The SEM is calculated as the standard deviation of the baseline test multiplied by the square root of one minus the published reliability coefficient for the test.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00057746
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|Study Chair:||Aaron H. Wolfson, MD||University of Miami Sylvester Comprehensive Cancer Center|