The Third Therapeutic Intervention in Malignant Effusion Trial (TIME3)

• Research type

  Research Study

• Full title

  Adjuvant Urokinase in the Treatment of Malignant Pleural Effusion: The Third Therapeutic Intervention in Malignant Effusion Trial (TIME3-UK). A Randomised Controlled Trial to evaluate whether use of intrapleural Urokinase aids the drainage of multi-septated pleural effusion compared to placebo

• Sponsor organisation

  University of Oxford

• Eudract number

  2008-000586-26

• ISRCTN Number

  ISRCTN12852177

• Research summary

  A cancer induced collection oflud between the lung and the chest wall (a pleural effusion), is one of the commonest problems in the palliative care of cancers affecting the chest. It affects ~200,000 patients each year (UK&US), including 25% of patients with lung cancer, 95% with mesothelioma and 40% with breast cancer. Thflud compresses the lung, causing breathlessness and chest pain. Standard care includes draininflud using a chest tube and attempting to Ó?stick? the lung to the chest wall once thflud is removed (pleurodesis) to prevenflud reaccumulation. However, in about 40% of patients, thflud is divided into pockets, and as a result drainage is often difficult. These patients often suffer with persistent breathlessness and require repeated painful procedures to try and drain thflud.Studies in patients with infecteflud around the lung show it is possible to use a drug, injected into thflud around the lung, to unite the separate pockets oflud thereby improvinflud drainage. We have shown in our pilot work at this can also be achieved in cancer induceflud collections. This trial will assess whether this improved drainage results in better control of breathlessness in patients with cancer induced pleural effusion resistant to standard drainage. More effectivflud removal may also improve the likelihood of later treatment, to adhere the pleural surfaces, being successful by bringing a greater pleural area into contact.If this trial has a positive outcome it will significantly improve care for one of the most common and disabling problems that arises in the palliative care of cancers affecting the chest. The trial is being funded by NCRI and will take place within the TVCLRN (Oxford, High Wycombe, Reading, Heatherwood and Wexham) and Bristol.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  09/H0604/5

• Date of REC Opinion

  20 Mar 2009

• REC opinion

  Further Information Favourable Opinion