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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
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
Secondary ID [1] 0 0
CDR0000258668
Secondary ID [2] 0 0
RTOG-0212
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 0 0
Colorectal Neoplasms 0 0
Colonic Neoplasms 0 0
Rectal Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Chronic Neurotoxicity
Timepoint [1] 0 0
From study registration to one year.
Primary outcome [2] 0 0
Progression free survival
Timepoint [2] 0 0
Throughout duration of study
Secondary outcome [1] 0 0
Time to progression
Timepoint [1] 0 0
Throughout duration of study
Secondary outcome [2] 0 0
Time to treatment failure
Timepoint [2] 0 0
Throughout duration of study
Secondary outcome [3] 0 0
Best overall response rate
Timepoint [3] 0 0
Throughout duration of study
Secondary outcome [4] 0 0
Tolerability and safety profile
Timepoint [4] 0 0
Throughout duration of study

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
Minimum age
No limit
Maximum age
120 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2013
Sample size
Target
Accrual to date
Final
265
Recruitment in Australia
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- Adelaide
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- Garran
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- Nedlands
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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
Recruitment outside Australia
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Oxford

Funding & Sponsors
Primary sponsor type
Other
Name
Radiation Therapy Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Bayer
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/study/NCT00057746
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.
Public notes

Contacts
Principal investigator
Name 0 0
Aaron H. Wolfson, MD
Address 0 0
University of Miami Sylvester Comprehensive Cancer Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00057746