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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00005887




Registration number
NCT00005887
Ethics application status
Date submitted
2/06/2000
Date registered
29/08/2003
Date last updated
10/05/2013

Titles & IDs
Public title
Radiation Therapy With or Without RSR13 in Treating Patients With Brain Metastases
Scientific title
A Phase III, Randomized, Open-Label, Comparative Study of Standard Whole Brain Radiation Therapy With or Without RSR13 in Patients With Brain Metastases
Secondary ID [1] 0 0
ALLOS-RSR13RT-009
Secondary ID [2] 0 0
CDR0000067957
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - efaproxiral
Treatment: Other - radiation therapy

Treatment: Drugs: efaproxiral


Treatment: Other: radiation therapy


Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Radiographically, histologically, or cytologically confirmed brain metastases with
histologically or cytologically confirmed primary malignancy except the following:

- Small cell lung cancer, germ cell tumors, and lymphomas

- No leptomeningeal metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 70-100%

Life expectancy:

- Not specified

Hematopoietic:

- Hemoglobin at least 10 g/dL

- WBC at least 2,000/mm3

- Platelet count at least 75,000/mm3

Hepatic:

- Bilirubin no greater than 2.0 mg/dL

- ALT and AST no greater than 3 times upper limit of normal

Renal:

- Creatinine no greater than 2.0 mg/dL

Pulmonary:

- Forced vital capacity and forced expiratory volume at least 50% of normal in patients
with significant intrathoracic tumor involvement, chronic obstructive pulmonary
disease, interstitial lung disease, or pulmonary embolism

- Resting and exercise oxygen saturation at least 90% on room air

Other:

- No other concurrent active malignancy from a second histologic site

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior biologic therapy or immunotherapy for brain metastases

- At least 28 days since prior investigational biologic therapy

Chemotherapy:

- No prior chemotherapy for brain metastases

- No chemotherapy for brain metastases for at least one month following radiation
therapy

- At least 7 days since prior chemotherapy for primary tumor or extracranial metastases

- No planned chemotherapy during radiation therapy

Endocrine therapy:

- No prior hormonal therapy for brain metastases

- Prior or concurrent corticosteroid therapy allowed

Radiotherapy:

- No prior whole brain radiotherapy for brain metastases

- No prior stereotactic radiosurgery for brain metastases

Surgery:

- Prior surgery allowed for brain metastases if at least one measurable lesion remains

Other:

- At least 28 days since prior investigational drug or device

- No prior RSR13
Minimum age
18 Years
Maximum age
No limit
Gender
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
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
Royal Prince Alfred Hospital Medical Center - Sydney
Recruitment hospital [2] 0 0
Queensland Radium Institute - Herston
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment hospital [4] 0 0
Austin and Repatriation Medical Centre - Heidelberg West
Recruitment postcode(s) [1] 0 0
2042 - Sydney
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
8006 - East Melbourne
Recruitment postcode(s) [4] 0 0
3081 - Heidelberg West
Recruitment outside Australia
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United States of America
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Arizona
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California
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Colorado
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Florida
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Illinois
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Louisiana
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Maryland
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Massachusetts
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New Jersey
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New York
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North Carolina
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North Dakota
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Ohio
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Pennsylvania
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Tennessee
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Texas
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Virginia
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Wisconsin
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Belgium
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Brussels (Bruxelles)
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Belgium
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Gent
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Belgium
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Leuven
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Newfoundland and Labrador
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Canada
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Saskatchewan
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France
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Dijon
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France
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Marseille
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France
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Montbeliard
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France
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Pierre Benite
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Germany
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Freiburg
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Germany
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Hamburg
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Gydr
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Hungary
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Miskolc
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Hungary
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Szeged
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Italy
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Aviano
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Italy
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Milano
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United Kingdom
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England
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United Kingdom
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Scotland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Spectrum Pharmaceuticals, Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as
RSR13 may make tumor cells more sensitive to radiation therapy.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the
brain with or without RSR13 in treating patients who have brain metastases.
Trial website
https://clinicaltrials.gov/show/NCT00005887
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Edward G. Shaw, MD
Address 0 0
Wake Forest University Health Sciences
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
Other publications