Brain Metastasis Clinical Trial
— CLQOfficial title:
Phase II Randomized, Double Blind, Placebo Controlled Study of Whole-brain Irradiation With Concomitant Daily-dose Chloroquine for Brain Metastases.
NCT number | NCT01894633 |
Other study ID # | CD-449-08 |
Secondary ID | |
Status | Terminated |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | May 2011 |
Est. completion date | January 2013 |
Verified date | January 2024 |
Source | Instituto Nacional de Cancerologia de Mexico |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background and purposes:Chloroquine (CLQ), an antimalarial drug, has a lysosomatrophic effect associate with increase the sensibility of Radiation through leakage of hidroliticenzimes, increase of apoptosis, autophagy mediated by lysosomalhidrolases and increase of oxidative stress "in vitro". In this phase II study we evaluated the efficacy and safety as radiosensitizing of the Chloroquine plus concomitant 30 Gray (Gy) of Whole-brain irradiation (WBI)in patients with brain metastases (BM) from solid tumors.
Status | Terminated |
Enrollment | 73 |
Est. completion date | January 2013 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 46 Years to 61 Years |
Eligibility | Inclusion Criteria: - 18 to 80 years of age - At leat one brain metastasis MRI - KPS 70 or more - RTOG-RPA I or II - Basic Laboratory requirements Exclusion Criteria: - Candidates for radiosurgery, neurosurgery - Patients treated with radiotherapy before entered to the study |
Country | Name | City | State |
---|---|---|---|
Mexico | Instituto Nacional de Cancerologia | Mexico DF | DF |
Lead Sponsor | Collaborator |
---|---|
Instituto Nacional de Cancerologia de Mexico |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Quality of life in brain metastases | The 30-item EORTC Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) version 3.0 (Mexican version) was used in this trial. The EORTC QLQ-C30 v3 consisted of five multi-item functional scales, three symptom scales, a global health status/QoL scale, and six single items | The quality of life questionnaires were completed 1 day before radiotherapy began and 1 month later. | |
Primary | Overall Response Rate | Corresponding Complete plus Partial Response according with RECIST 1.1 Criteria | Every third month after randomization until 24 months follow-up. Measured by brain MRI | |
Secondary | Central Nervous System Progression Free Survival | Clinical o radiological brain progression or death. Radiological Progression is measured by RECIST 1.1 Criteria | From time to progression to 24 months follow up |
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