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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00057746
Registration number
NCT00057746
Ethics application status
Date submitted
7/04/2003
Date registered
9/04/2003
Date last updated
25/05/2016
Titles & IDs
Public title
Brain Irradiation in Treating Patients With Limited-Stage Small Cell Lung Cancer
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Scientific title
A Phase II Randomized Trial Of Two Dose Schedules For Delivering Prophylactic Cranial Irradiation For Patients With Limited Disease Small Cell Lung Cancer
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Secondary ID [1]
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CDR0000258668
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Secondary ID [2]
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RTOG-0212
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lung Cancer
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Colorectal Neoplasms
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0
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Colonic Neoplasms
0
0
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Rectal Neoplasms
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0
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Condition category
Condition code
Cancer
0
0
0
0
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Lung - Mesothelioma
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Cancer
0
0
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0
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Lung - Non small cell
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Cancer
0
0
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0
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Lung - Small cell
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Cancer
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0
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Prophylactic cranial irradiation, 2.5 Gy fx
Treatment: Other - Prophylactic cranial irradiation, 2.0 Gy fx
Treatment: Other - Prophylactic cranial irradiation, 1.5 Gy fx
Active comparator: Arm I - Prophylactic cranial irradiation, 2.5 Gy fx
Experimental: Arm II - Prophylactic cranial irradiation, 2.0 Gy fx
Experimental: Arm III - Prophylactic cranial irradiation, 1.5 Gy fx
Experimental: 1 - Oxaliplatin/5-FU/LV and PTK787/ZK 222584
Placebo comparator: 2 - Oxaliplatin/5-FU/LV and placebo
Treatment: Other: 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
Treatment: Other: 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
Treatment: Other: 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
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of Chronic Neurotoxicity
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Assessment method [1]
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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.
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Timepoint [1]
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From study registration to one year.
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Primary outcome [2]
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Progression free survival
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Timepoint [2]
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Throughout duration of study
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Secondary outcome [1]
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Time to progression
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Assessment method [1]
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Timepoint [1]
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Throughout duration of study
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Secondary outcome [2]
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Time to treatment failure
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Assessment method [2]
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Timepoint [2]
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Throughout duration of study
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Secondary outcome [3]
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Best overall response rate
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Assessment method [3]
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Timepoint [3]
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Throughout duration of study
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Secondary outcome [4]
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Tolerability and safety profile
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Assessment method [4]
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Timepoint [4]
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Throughout duration of study
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Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed small cell lung cancer by fine needle aspiration, biopsy, or 2 positive sputa
* Limited stage (I-IIIB)
* Confined to 1 hemithorax
* No T4 based on malignant pleural effusion, or N3 disease based on contralateral hilar or contralateral supraclavicular involvement
* Complete response after induction chemotherapy (with or without thoracic radiotherapy)
* Consolidative chest radiotherapy may be initiated before study
* No radiographic evidence of any of the following:
* Brain metastases
* Normal brain CT scan or MRI less than 1 month before study
* Ipsilateral lung metastases
* Malignant pleural effusion
* Minimal pleural effusion by chest CT scan allowed, but not by chest x-ray
PATIENT CHARACTERISTICS:
Age
* Not specified
Performance status
* Zubrod 0-1
Life expectancy
* Not specified
Hematopoietic
* Absolute granulocyte count at least 1,500/mm^3
* Platelet count at least 75,000/mm^3
* Hemoglobin at least 10.0 g/dL^
Hepatic
* Not specified
Renal
* Not specified
Pulmonary
* See Disease Characteristics
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Neurological function class 1 or 2
* No epilepsy requiring permanent oral medication
* No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
* No other serious medical or psychiatric condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
* At least 1 week since prior chemotherapy
* No concurrent chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* No prior external beam radiotherapy to the head or neck, including stereotactic radiotherapy
* Concurrent thoracic radiotherapy allowed
Surgery
* Not specified
Other
* No concurrent antitumor agents
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Minimum age
No limit
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Maximum age
120
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2003
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2013
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Sample size
Target
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Accrual to date
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Final
265
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Recruitment in Australia
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- Adelaide
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- Garran
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- Nedlands
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- Wollongong
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- Woolloongabba
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SA 5000 - Adelaide
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ACT 2605 - Garran
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WS 6009 - Nedlands
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NSW 2500 - Wollongong
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QLD 4102 - Woolloongabba
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Oxford
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Funding & Sponsors
Primary sponsor type
Other
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Name
Radiation Therapy Oncology Group
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Address
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National Cancer Institute (NCI)
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Ethics approval
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Summary
Brief summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT00057746
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Trial related presentations / publications
Gondi V, Paulus R, Bruner D, et al.: Prognostic significance of QOL deterioration during early lung cancer survivorship: secondary analysis of RTOG 0212 and 0214. [Abstract] J Clin Oncol 29 (Suppl 15): A-6061, 2011. Le Pechoux C, Dunant A, Senan S, Wolfson A, Quoix E, Faivre-Finn C, Ciuleanu T, Arriagada R, Jones R, Wanders R, Lerouge D, Laplanche A; Prophylactic Cranial Irradiation (PCI) Collaborative Group. Standard-dose versus higher-dose prophylactic cranial irradiation (PCI) in patients with limited-stage small-cell lung cancer in complete remission after chemotherapy and thoracic radiotherapy (PCI 99-01, EORTC 22003-08004, RTOG 0212, and IFCT 99-01): a randomised clinical trial. Lancet Oncol. 2009 May;10(5):467-74. doi: 10.1016/S1470-2045(09)70101-9. Epub 2009 Apr 20. 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. Wolfson AH, Bae K, Komaki R, Meyers C, Movsas B, Le Pechoux C, Werner-Wasik M, Videtic GM, Garces YI, Choy H. Primary analysis of a phase II randomized trial Radiation Therapy Oncology Group (RTOG) 0212: impact of different total doses and schedules of prophylactic cranial irradiation on chronic neurotoxicity and quality of life for patients with limited-disease small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2011 Sep 1;81(1):77-84. doi: 10.1016/j.ijrobp.2010.05.013. Epub 2010 Aug 26. Hecht JR, Trarbach T, Hainsworth JD, Major P, Jager E, Wolff RA, Lloyd-Salvant K, Bodoky G, Pendergrass K, Berg W, Chen BL, Jalava T, Meinhardt G, Laurent D, Lebwohl D, Kerr D. Randomized, placebo-controlled, phase III study of first-line oxaliplatin-based chemotherapy plus PTK787/ZK 222584, an oral vascular endothelial growth factor receptor inhibitor, in patients with metastatic colorectal adenocarcinoma. J Clin Oncol. 2011 May 20;29(15):1997-2003. doi: 10.1200/JCO.2010.29.4496. Epub 2011 Apr 4.
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Aaron H. Wolfson, MD
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University of Miami Sylvester Comprehensive Cancer Center
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Wolfson AH, Bae K, Komaki R, Meyers C, Movsas B, L...
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Results are available at
https://clinicaltrials.gov/study/NCT00057746
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