Evidence map›Paper›PMID 24010771›Full record

Trial reportRadiation oncology (London, England)2013

Phase II randomized, double-blind, placebo-controlled study of whole-brain irradiation with concomitant chloroquine for brain metastases.

Luis L Rojas-Puentes, Marcelino Gonzalez-Pinedo, Alejando Crismatt, Alette Ortega-Gomez, Carlos Gamboa-Vignolle, Rodrigo Nuñez-Gomez, Yusmiren Dorantes-Gallareta, Claudia Arce-Salinas, Oscar Arrieta

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Radiation oncology (London, England), 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04338867 (Nitroglycerin Plus Whole Intracranial Radiotherapy for Brain Metastases in Non-small Cell Lung Cancer Patients), which is not on this map. Cited by 82 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
82citing papers in PubMed, 3 pooled it
3.8field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04338867 phase2completednot on this mapstarted 2020, after this paper: background citation

Nitroglycerin Plus Whole Intracranial Radiotherapy for Brain Metastases in Non-small Cell Lung Cancer Patients: a Phase II Open Randomized Clinical Trial

TypeinterventionalSponsorInstituto Nacional de Cancerologia de MexicoRan2020 to 2020Enrolled96ConditionsPhase II Clinical Trial, Ninety-six Histologically Confirmed NSCLC Patients With BM, Randomized 1:1 to Received TN Plus WBR or Only WBR, ICPFS Evaluated by Two Blinded and Independent Radio-oncologist With MRIArmsWhole-brain radiotherapy
3 · Its place in the literature

Who cites it

82 citing papers in PubMed, 3 syntheses or guidelines pooled it, 128 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Autophagy modulation in cancer.Nature reviews. Drug discovery · 2026
    Review
  5. Review
  6. Review
  7. Targeting Lysosomes for Enhanced Anti-Cancer Therapeutics and Immune Response.International journal of biological sciences · 2026
    Review
  8. Review
  9. Review
  10. Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. The role of autophagy in hypoxia-induced radioresistance.Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2023
    Review
  16. Review
  17. Article
  18. Article
  19. Review
  20. Review

22 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

Luis L Rojas-PuentesMedical Oncology Department, Instituto Nacional de Cancerología de México(INCan), San Fernando N22 Colonia Sección XVI, Tlalpan Mexico City, Mexico. ogar@servidor.unam.mx.
Marcelino Gonzalez-Pinedo
Alejando Crismatt
Alette Ortega-Gomez
Carlos Gamboa-Vignolle
Rodrigo Nuñez-Gomez
Yusmiren Dorantes-Gallareta
Claudia Arce-Salinas
Oscar Arrieta
Instituto Nacional de Cancerología · MXMSD (Mexico) · MX

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

background and purposeChloroquine (CLQ), an antimalarial drug, has a lysosomotropic effect associated with increased radiationsensibility, which is mediated by the leakage of hydrolytic enzymes, increased apoptosis, autophagy and increased oxidative stress in vitro. In this phase II study, we evaluated the efficacy and safety of radiosensibilization using CLQ concomitant with 30 Gray (Gy) of whole-brain irradiation (WBI) to treat patients with brain metastases (BM) from solid tumors.

methodsSeventy-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 arm). 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 Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) (Mexican version) before beginning radiotherapy and one month later.

resultsThe overall response rate (ORR) was 54% for the CLQ arm and 55% for the control arm (p=0.92). The progression-free survival of brain metastases (BMPFS) rates at one year were 83.9% (95% CI 69.4-98.4) for the CLQ arm and 55.1% (95% CI 33.6-77.6) for the control arm. Treatment with CLQ was independently associated with increased BMPFS (RR 0.31,95% CI [0.1-0.9], p=0.046).The only factor that was independently associated with increased overall survival (OS) was the presence of< 4 brain metastases (RR 1.9, 95% CI [1.12-3.3], p=0.017). WBI was associated with improvements in cognitive and emotional function but also with worsened nausea in both patients groups. No differences in QoL or toxicity were found between the study arms.

conclusionTreatment with CLQ plus WBI improved the control of BM (compared with the control arm) with no increase in toxicity; however, CLQ did not improve the RR or OS. A phase III clinical trial is warranted to confirm these findings.

Indexed as

AdultAgedBrain NeoplasmsChemoradiotherapyChloroquineCranial IrradiationDisease-Free SurvivalDouble-Blind MethodFemaleHumansKaplan-Meier EstimateMaleMiddle AgedProportional Hazards ModelsQuality of LifeRadiation-Sensitizing AgentsChloroquineRadiation-Sensitizing Agents

Identifiers

PMID24010771
PMCPMC3848663
OpenAlexW2119215169

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.