What stage is the STELLAR trial?
The STELLAR trial for patients with mesothelioma is a Pilot trial that builds on experience from comprehensive preclinical experiments and clinical studies not directly done for the medical condition under investigation. Because the NovoTTF-100L System is a device and not a drug, it does not follow the traditional Phase I, Phase II, Phase III process that an investigational new drug would follow. This Pivotal Trial is similar in structure and purpose to a drug Phase II trial.
How can I take part in the STELLAR trial?
What are the expected side effects of TTFields?
The use of the NovoTTF-100L System is not expected to have systemic side effects, based on our clinical data to date for various indications. Patients have experienced skin irritation beneath the transducer arrays. For more information, see Science of TTFields.
When TTFields are delivered, the transducer arrays may cause mild warming and tingling of the skin underneath them.
Please consult with a study physician at one of the centers participating in the trial or additional information about potential side effects from using the NovoTTF-100L and the other treatments in the STELLAR clinical trial.
Do I need to carry the device all the time?
The system and the portable battery weigh about 3 kilograms altogether and can be carried in a dedicated shoulder bag or backpack when walking around. Patients may not necessarily be physically carrying the system most of the time, but will rather use it while it is continuously placed in one location (e.g. on a desk, a table or on the floor inside the carrying bag). The system was designed to allow the performance of normal daily routines. For more information on lifestyle related questions, please visit Living with TTFields.
Will the use of TTFields pose any risk to family members or other people?
The use of the device will not interfere with household or standard personal electrical devices. There is no exposure of TTFields to non-users, such as co-workers and family members.
How will the device affect my social life?
You can use the device while maintaining most of your daily routines. The transducer arrays will be concealed underneath your clothes. The Device Support Specialist (DSS) will offer help and support related to appearance issues if you are using TTFields. For additional information, please see Living with TTFields.
If I enroll in the STELLAR trial, will I receive TTFields for my illness
Yes, all patients enrolled in the STELLAR trial will receive TTFields, alongside with the best standard chemotherapy currently used to treat this medical condition.
How long do I need to wear the device in the STELLAR trial?
Patients wear the device throughout the day and night. Patients may remove the device for short breaks to accommodate personal needs. Treatment on the trial continues until your study doctor diagnoses progression of the mesothelioma tumor according to the protocol, or until a serious medical condition requires discontinuation of the treatment. In addition, you may decide to stop the TTFields at any point in time after starting the use of the device. For more information about the STELLAR trial, see The STELLAR trial or contact one of the participating centers.