PROTIS

• Research type

  Research Study

• Full title

  PROton beam Therapy versus Intensity-modulated radiotherapy for Sinonasal cancer

• IRAS ID

  325882

• Contact name

  David Thomson

• Contact email

  david.thomson2@nhs.net

• Sponsor organisation

  The Christie NHS Foundation Trust

• Duration of Study in the UK

  7 years, 5 months, 30 days

• Research summary

  Cancer of the sinuses (the air spaces in our face around the nose) is a rare but devastating disease, which is often aggressive and extensive by the time something is noticed to be wrong.
  Radiotherapy is an important part of the treatment. It is used to treat cancer cells that remain after surgery (that would otherwise grow back), but is also used to treat the cancer itself (where surgery has not been done). Chemotherapy may be added as well.
  However, the use of radiotherapy is complicated because of the closeness to critical areas, (eg the eyes and brain) which can be damaged by radiotherapy. This may sometimes cause serious long-term side effects including eye pain, loss of vision, problems with thinking or memory, epilepsy, sinus inflammation or blockage, reduced hormone levels and difficulties hearing and smelling.
  Intensity-modulated radiotherapy (IMRT) is the current standard treatment. It is a way of targeting a tumour in the body more precisely and has helped to improve cure rates and reduce side effects compared with older techniques.
  Proton beam therapy (PBT) is a newer form of radiotherapy which may further improve delivery of radiation. This trial will compare cure rates of PBT to the standard IMRT treatment. It will also gather information on side effects of each, to determine whether one treatment causes less damage than the other.
  Participants have a 50:50 chance of receiving IMRT at a local hospital, or PBT at one of the specialist UK proton centres (Manchester or London). Delivery of radiotherapy will happen over 6-7 weeks. All other treatment decisions and options will be the same whether taking part in the study or not. After completing the radiotherapy participants will attend follow-up clinical appointments for up to 5 years (which match normal care) at set times so that any side-effects can be recorded.

• REC name

  London - Surrey Research Ethics Committee

• REC reference

  23/LO/0933

• Date of REC Opinion

  13 Nov 2023

• REC opinion

  Favourable Opinion