Study of Whole-brain Irradiation With Chloroquine for Brain Metastases
NCT ID: NCT01894633
Last Updated: 2024-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
73 participants
INTERVENTIONAL
2011-05-31
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Chloroquine, radiosensitizer
The patients in the Chloroquine group received 30 Gy of total brain radiotherapy in 10 daily fractions from Monday to Friday. Furthermore, the CLQ plus WBI arm received a daily single dose of 150 mg CLQ po 1 hour prior to the radiation treatment, beginning during the first radiotherapy fraction and continuing for 28 days.
Chloroquine
The patients in the Chloroquine group received 30 Gy of total brain radiotherapy in 10 daily fractions from Monday to Friday. Furthermore, the Chloroquine plus WBI arm received a daily single dose of 150 mg CLQ po 1 hour prior to the radiation treatment, beginning during the first radiotherapy fraction and continuing for 28 days
Total brain radiotherapy
30 Gy in 10 daily fractions from Monday to Friday
Placebo
30 Gy of whole-brain radiotherapy in 10 daily fractions and an oral matching placebo for 28 days
Total brain radiotherapy
30 Gy in 10 daily fractions from Monday to Friday
Interventions
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Chloroquine
The patients in the Chloroquine group received 30 Gy of total brain radiotherapy in 10 daily fractions from Monday to Friday. Furthermore, the Chloroquine plus WBI arm received a daily single dose of 150 mg CLQ po 1 hour prior to the radiation treatment, beginning during the first radiotherapy fraction and continuing for 28 days
Total brain radiotherapy
30 Gy in 10 daily fractions from Monday to Friday
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At leat one brain metastasis MRI
* KPS 70 or more
* RTOG-RPA I or II
* Basic Laboratory requirements
Exclusion Criteria
* Patients treated with radiotherapy before entered to the study
46 Years
61 Years
ALL
No
Sponsors
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Instituto Nacional de Cancerologia de Mexico
OTHER
Responsible Party
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Oscar Gerardo Arrieta RodrÃguez
Principal Investigator
Principal Investigators
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Oscar Arrieta, MD
Role: PRINCIPAL_INVESTIGATOR
Instituto Nacional de Cancerologia, Columbia
Locations
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Instituto Nacional de Cancerologia
Mexico City, Mexico City, Mexico
Countries
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Other Identifiers
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CD-449-08
Identifier Type: -
Identifier Source: org_study_id
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