Clinical trials are medical trials which compare the effects of one medical treatment with another. They help doctors understand how to treat a particular disease or condition. If you take part in a medical trial, you may be the first person to receive a brand new treatment which may be more effective. However, it is also a possibility that the treatment may not work, or could be less effective than the standard treatments available.
Below we discuss past and present trials covering mesothelioma treatment which are giving patients hope by driving research towards improved treatment. In the long run, mesothelioma trials hope to increase the life span and importantly, the quality of life of mesothelioma sufferers around the world.
Can surgery help mesothelioma sufferers?
There have only been a few trials looking at whether surgery helps people with mesothelioma. Other options involve other treatments such as radiotherapy and chemotherapy and are sometimes considered to be more effective if they are used in conjunction with surgery. Below we look at past and present trials covering these treatments.
The initial MARS trial (Mesothelioma and Radical Surgery) took place between 2005 and 2008. Its aim was to uncover whether a combination of radical surgery and radiotherapy would help people suffering with mesothelioma.
50 participants were randomised, and around half (24) received an Extra Pleural Pneumonectomy operation and radiotherapy, whereas the other half received radiotherapy alone. An Extra Pleural Pneumonectomy (EPP) operation involves the removal of the affected lung, the diaphragm, and the covering of the heart.
Unfortunately, the trial found that people who did not undergo the EPP tended to live longer, and also that they had a better quality of life. A larger trial was therefore no longer considered to be feasible.
MARS 2 Trial
The MARS 2 Trial began in 2015 and is still currently recruiting volunteers with mesothelioma. The volunteers may receive a combination of surgery and chemotherapy versus chemotherapy alone, if they are selected as part of randomised selection. The trial will be recruiting until mid-2017.
The surgery is less severe than that used during the initial MARS trial and is known as lung-sparing surgery. The operation is called a pleurectomy, decortication and involves the removal of:
- Any visible mesothelioma.
- The hardened and thickened outer layer of the surface of the lung.
- The lung covering.
Some patients may also require the removal of part, or all, of the heart lining, and the sheet of muscle just under the rib cage.
The trial aims to identify whether chemotherapy and surgery is more effective than chemotherapy alone. The hope is that the combination treatment may extend and improve the quality of life of mesothelioma patients.
You can join the trial if:
- You have pleural mesothelioma affecting only one side of your chest.
- You are well enough to carry out all your normal activities, apart from heavy physical work.
To find out how you can get involved in the trial, side effects, exemptions, and locations, please visit: http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-surgery-for-mesothelioma-mars-2#undefined
Which drugs are most effective in treating mesothelioma?
Other studies aim to test the effectiveness of different chemotherapy and non-chemotherapy drugs in reducing the cancer and increasing the quality of life for sufferers. Details of some recent or on-going studies are detailed below:-
VIM is a clinical trial which aims to find out how well the chemotherapy drug, vinorelbine works in treating mesothelioma and to learn more about its side effects.
Participants will be randomly split into two groups. Group I will receive the drug, vinorelbine and active symptom control (which may include: painkillers, blood transfusions, high calorie drinks and steroids), with group II receiving active symptom control alone.
The entry conditions for this trial are extensive. Please visit http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-adi-peg-20-pemetrexed-cisplatin-lung-cancer-mesothelioma-trap-study#undefined to find out more.
This study will involve testing the effectiveness of a drug called API-PEG 20 when used in combination with two existing chemotherapy drugs known as cisplatin and pemetrexed.
API-PEG 20 works by removing the amino acid ‘argine.’ Argine helps cells to grow, but as cancer cells often do not contain this protein, removing this amino acid from the body may restrict cancer growth.
Part I of this trial has closed, but part II is still accepting participants. Part I was a dose escalation study, which determined the safe amount of API-PEG 201 which could be given to patients taking part in part II.
Participants involved in part II of the trial are provided with the established safe amount of ADI-PEG 20 along with the chemotherapy drugs listed above. Patients in the trial can only receive between 4 and 6 treatments of the chemotherapy drugs, but may continue receiving ADI-PEG 20 for as long as it is beneficial, whilst monitoring of the side effects continues.
Overall, the researchers aim to establish how ADI-PEG 20 works and what effect it has on a patient’s body.
Why are clinical trials so important and should you get involved?
Clinical trials are vital in ensuring that research is constantly moving forward. More research breeds greater, effective treatment options for everyone diagnosed with mesothelioma, hopefully allowing those diagnosed in the future to live longer and more comfortably with this terrible asbestos related condition.
For mesothelioma patients with few treatment options, clinical trials may offer fresh hope. However, it is important to remember that not all clinical trials are effective and some treatment options adopted as part of trials can result in detrimental effects on the quality of life and lifespan of the sufferer.
Furthermore, in randomised trials you may be part of the group that does not receive any new drugs or treatment options. You may even receive placebo drugs. This can be disappointing and may affect your emotional wellbeing. It’s important to decide what’s best for you personally. Research every trial thoroughly and ask your doctor as many questions as possible. Cancer Research UK provides advice regarding what questions you might want to ask here:
Most clinical trials allow you to drop out at any time and resume the standard treatment that the hospital would have given you if you had decided not to partake in trial.
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