Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00054795




Registration number
NCT00054795
Ethics application status
Date submitted
10/02/2003
Date registered
13/02/2003
Date last updated
8/05/2007

Titles & IDs
Public title
Study of Neurologic Progression With Motexafin Gadolinium and Radiation Therapy (SMART)
Scientific title
Randomized Phase III Trial of Xcytrin® (Motexafin Gadolinium) Injection for the Treatment of Brain Metastases in Patients With Non-Small Cell Lung Cancer Undergoing Whole Brain Radiation Therapy
Secondary ID [1] 0 0
PCYC-0211
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain Neoplasms 0 0
Carcinoma, Non-Small-Cell Lung 0 0
Metastases, Neoplasm 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
* Adults (=18 years old) with radiologically proven parenchymal brain metastases from histologically confirmed non-small cell lung cancer;
* KPS score of =70;
* Each patient must sign a study-specific Informed Consent form
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Liver metastases;
* Extracranial metastases in two or more organs;
* Known leptomeningeal metastases or subarachnoid spread of tumor;
* Prior whole brain radiation;
* Plan to use radiosurgery or radiation boost after completion of WBRT;
* Planned chemotherapy during study treatment (prior and subsequent chemotherapy is allowed);
* Prior total resection of a single brain metastasis;
* Laboratory values as follows:

LDH > 1.3 x upper limit of normal (ULN); ANC < 1500 /mm³; Platelets < 50,000 /mm³; Creatinine > 2.0 mg/dL; AST or ALT > 2 x ULN; Total bilirubin > 2 x ULN;

* Women who are pregnant or lactating

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 3
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
- Liverpool
Recruitment hospital [2] 0 0
- St. Leonards
Recruitment hospital [3] 0 0
- Wollongong
Recruitment hospital [4] 0 0
- Herston
Recruitment hospital [5] 0 0
- Woollongabba
Recruitment hospital [6] 0 0
- East Melbourne
Recruitment hospital [7] 0 0
- Footscray
Recruitment hospital [8] 0 0
- Geelong
Recruitment hospital [9] 0 0
- Heidelberg
Recruitment postcode(s) [1] 0 0
- Liverpool
Recruitment postcode(s) [2] 0 0
- St. Leonards
Recruitment postcode(s) [3] 0 0
- Wollongong
Recruitment postcode(s) [4] 0 0
- Herston
Recruitment postcode(s) [5] 0 0
- Woollongabba
Recruitment postcode(s) [6] 0 0
- East Melbourne
Recruitment postcode(s) [7] 0 0
- Footscray
Recruitment postcode(s) [8] 0 0
- Geelong
Recruitment postcode(s) [9] 0 0
- Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
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Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Nebraska
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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Ohio
Country [19] 0 0
United States of America
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Pennsylvania
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United States of America
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Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
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United States of America
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Virginia
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United States of America
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Wisconsin
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Austria
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Linz
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Austria
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Wien
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Belgium
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Antwerpen
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Belgium
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Bruxelles
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Belgium
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Haine-Saint-Paul
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Belgium
State/province [29] 0 0
Leuven
Country [30] 0 0
Canada
State/province [30] 0 0
Alberta
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Canada
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Nova Scotia
Country [32] 0 0
Canada
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Ontario
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Canada
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Quebec
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France
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Caen
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France
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Lille
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France
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Lyon
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France
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Montbeliard
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France
State/province [38] 0 0
Nice
Country [39] 0 0
France
State/province [39] 0 0
Pierre Benite
Country [40] 0 0
France
State/province [40] 0 0
Rennes
Country [41] 0 0
France
State/province [41] 0 0
Saint Herblain
Country [42] 0 0
France
State/province [42] 0 0
Vandoeuvre Les Nancy
Country [43] 0 0
France
State/province [43] 0 0
Villejuif
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Germany
State/province [44] 0 0
Aachen
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Germany
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Berlin
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Germany
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Essen
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Germany
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Freiberg
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Germany
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Hamburg
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Germany
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Heidelberg
Country [50] 0 0
Germany
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Herne
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Germany
State/province [51] 0 0
Magdeburg
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Germany
State/province [52] 0 0
Munchen
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Netherlands
State/province [53] 0 0
Gravenhage
Country [54] 0 0
Netherlands
State/province [54] 0 0
Heerlen
Country [55] 0 0
Netherlands
State/province [55] 0 0
Rotterdam

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pharmacyclics LLC.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00054795