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Clinical Trial Details — Status: Terminated

Administrative data

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

Study information

Verified date January 2024
Source Instituto Nacional de Cancerologia de Mexico
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Seventy-three eligible patients were randomized. Thirty-nine patients received WBI (30 Gy in 10 fractions over 2 weeks) concomitant with 150 mg of CLQ for 4 weeks (the CLQ group). Thirty-four patients received the same schedule of WBI concomitant with a placebo for 4 weeks (the control arm). All the patients were evaluated for quality of life (QoL) using the EORTC QLQ-C30 questionnaire (Mexican version) before beginning radiotherapy and one month later.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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
Radiation:
Total brain radiotherapy
30 Gy in 10 daily fractions from Monday to Friday

Locations

Country Name City State
Mexico Instituto Nacional de Cancerologia Mexico DF DF

Sponsors (1)

Lead Sponsor Collaborator
Instituto Nacional de Cancerologia de Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

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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