Current efforts in research of pleural mesothelioma-An analysis of the ClinicalTrials.gov registry

Our plain-English summary of Current efforts in research of pleural mesothelioma-An analysis of the ClinicalTrials.gov registry, by K. Süveg, P.M. Putora, T. Berghmans, et al (Lung Cancer, 2018).

The study

• Authors: K. Süveg, P.M. Putora, T. Berghmans, M. Glatzer, V. Kovac, N. Cihoric
• Journal: Lung Cancer
• Published: 2018;124:12-18
• Type of article: Review
• Cited by: 7 articles, as counted by NIH iCite
• Read it: PubMed · Publisher

Abstract

Objectives: Currently there are many uncertainties in the optimal treatment of malignant pleural mesothelioma (MPM), this is reflected in discrepancies between current guidelines. Our aim was to evaluate the current status of prospective interventional clinical trials within the ClinicalTrials.gov registry in MPM in order to predict a potential impact on MPM management in the next years.

Material And Methods: The records of 263.832 clinical trials registered were searched in December 2017. Trials starting between 2005 and 2017 (n = 262) were selected for further manual review. Trials including other tumour entities or mesothelioma originating outside the pleura (n = 94) were excluded, as well as trials where the primary endpoint has already been published (n = 22).

Results: In total, 91 clinical trials were identified and selected for further analysis. Most trials had a single arm design, were in phase I, and were non-randomized. Academic centres were recorded as primary sponsors in the majority of trials (56%), followed by industry in 21%. Most studies investigated targeted (n = 42) or cytotoxic therapies (n = 39). Ten studies investigated different genetic therapies. In 67% of the trials (n = 61) targeted and/or cytotoxic therapies were involved. Treatments involving surgery were investigated in 12 trials (13%), radiotherapy in 10 trials (11%). Only five studies (6%) were phase 3 studies and one was a phase 2/3 study. Four of these five phase 3 trials investigated targeted therapies, while one trial investigated prophylactic radiotherapy of operative tracts.

Conclusions: Currently running trials in MPM are mostly in early phases and dominated by systemic therapies. Very few trials evaluate loco-regional therapeutic approaches. The current controversy surrounding the use of surgery and radiotherapy within multimodal therapy strategies will not be answered by these trials in the coming years.

Copyright © 2018 Elsevier B.V. All rights reserved.

In plain English

This study analysed a clinical trial registry. It did not study patients or asbestos exposure. In December 2017 the authors searched all trials registered on ClinicalTrials.gov for trials listing mesothelioma. They excluded trials that started before 2005; were suspended, terminated, withdrawn or of unknown status; included other cancers or mesothelioma outside the pleura; or had already published their main result. That left 91 trials of malignant pleural mesothelioma. Academic centres were primary sponsors of 56% of trials and industry of 21%. Fifty-one trials (56%) were initiated in the United States. Targeted therapies were studied in 42 trials and cytotoxic therapies in 39. Surgery was involved in 12 trials (13%) and radiotherapy in 10 (11%). Only five trials (6%) were phase 3 and one was phase 2/3. Four of the five phase 3 trials tested targeted therapies, and one tested prophylactic radiotherapy of operative tracts. The authors concluded that running trials are mostly early phase and dominated by systemic therapies. They also concluded that the controversy over surgery and radiotherapy will probably not be solved in the coming years. They noted that the registry is primarily intended for US trials.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: Analysis of trials registered in the ClinicalTrials.gov registry (not a patient study)
• Who was studied: 91 registered clinical trials on malignant pleural mesothelioma that started between 2005 and 2017. They were identified from a December 2017 search of all ClinicalTrials.gov records for 'mesothelioma'. The article prints the number of records searched as '263.832', using a period as a thousands separator.
• Exposure: No asbestos exposure was studied. The authors classified the treatments tested in the trials as cytotoxic, targeted, genetic, radiotherapy, surgery or other.
• Main results:
  • Academic centres were primary sponsors in 56% of the 91 trials and industry in 21%
  • 51 trials (56%) were initiated in the United States and 8 (9%) in Italy
  • 48 trials (53%) reported only one recruitment centre
  • Median expected enrolment per trial was 47 participants (range 6 to 1000)
  • 42 trials investigated targeted therapies and 39 investigated cytotoxic therapies
  • Surgery was involved in 12 trials (13%) and radiotherapy in 10 trials (11%)
  • Five trials (6%) were phase 3 and one was phase 2/3. Of the five phase 3 trials, four investigated targeted therapies and one investigated prophylactic radiotherapy of operative tracts.
• The authors' conclusion: The authors concluded that currently running trials in pleural mesothelioma are mostly early phase and dominated by systemic therapies. They found that very few trials evaluate loco-regional approaches, and that the controversy over surgery and radiotherapy will probably not be solved in the coming years.
• Limitations the authors state:
  • ClinicalTrials.gov is primarily intended for trials started by US investigators and companies
  • Some trials may have been registered only in other databases
  • Registry-based or observational trials may not be included
  • Some trials may have been missed or misclassified during selection
  • Not all trials started in the period were registered

Topics

The National Library of Medicine indexes this study under subjects our site covers: Lung cancer, Mesothelioma.

Medical terms in this study, explained in our Lexicon: Pleural Mesothelioma, Clinical Trial, Mesothelioma, Pleura, Multimodal Therapy.

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