Mesothelioma patients at risk for a serious treatment complication called procedure tract metastasis (PTM) may face a more promising prognosis when the results of a new clinical trial are in.
Many mesothelioma patients undergo some type of interventional therapy, such as surgery or drainage of excess lung fluid. Unfortunately, any time an instrument is introduced into the chest of a patient with mesothelioma, there is a risk that the patient will develop new tumors along the path of the incision or catheter tract. These PTMs can not only be painful but they can also accelerate the progression of mesothelioma and make treatment more complicated.
Now, a group of researchers in Great Britain have launched a new trial to determine whether giving patients some radiotherapy at the site of the intervention shortly after surgery could help keep PTMs from developing. The “surgical and large bore procedures in malignant pleural mesothelioma and radiotherapy” (SMART) trial will compare the PTM rates of mesothelioma patients who have had various types of treatment interventions, with or without prophylactic radiotherapy.
The new trial, which is just getting started, will recruit 203 UK mesothelioma patients who have undergone thoracic surgery, thoracoscopy (a less invasive procedure using a camera for guidance), or have had pleural fluid drained either with a large bore chest drain or a catheter that stays in the chest. All of these procedures involve putting an instrument into the pleural cavity where mesothelioma grows and all are known to increase the risk of PTM. Patients will be selected at random to either have radiotherapy shortly after their treatments (within 42 days) as a way to prevent PTMs or to have it only if a PTM develops.
Doctors from more than a half dozen British hospitals will be carefully measuring the rates of PTM and the complications of radiotherapy in both groups. A patient will be recorded as having a PTM if the nodule can be felt, is at least 1 cm in diameter, and occurs within 7 cm of the site of the mesothelioma procedure.
The trial has been approved by an ethics committee. The next stage will be to recruit mesothelioma patients. The researchers plan to publish the results of the SMART trial in a peer-reviewed medical journal and present the findings at international conferences.
Clive, Amelia et al, “Protocol for the surgical and large bore procedures in malignant pleural mesothelioma and radiotherapy trial (SMART Trial): an RCT evaluating whether prophylactic radiotherapy reduces the incidence of procedure tract metastases”, January 9, 2015, BMJ Open, Volume 5, Issue 1