PROton beam Therapy versus Intensity-modulated radiotherapy for Sinonasal cancer
Non-metastatic sinonasal cancer
PROTIS is an open-label phase III multi-centre prospective randomised controlled trial. The overall aim is to assess whether proton beam therapy (PBT) compared with standard-of-care intensity-modulated radiotherapy (IMRT) improves cure rates for patients with sinonasal cancer. Secondary to this is to assess the long-term side effects and impact on quality of life. The trial aims to recruit 276 patients with non-metastatic sinonasal cancer from 20 UK sites. Patients have a 50:50 chance of being allocated to receive either standard of care IMRT or PBT. Treatment will be given over 6-7 weeks. Following treatment patients will enter a follow-up phase of up to 5 years (2 years minimum) where they will attend regular clinical visits. Participant identification Potential participants will be identified during multi-disciplinary team (MDT) meetings at their local hospital. During these meetings which include various clinical teams, diagnostic scans (MRI or CT-chest) and biopsies will be reviewed and decisions on patient treatment will be documented. Depending on the size and location of the tumour a patient may require surgery to try and remove the cancer or induction chemotherapy to reduce or shrink the cancer. These treatments will need to be delivered before beginning radiotherapy treatment (as standard of care). The decision for these treatments will be the same whether a patient is taking part in the trial. Depending on which treatment is recommended participants will enter the trial either via a surgical or oncology pathway. If a patient is identified as potentially eligible for the study, they will be approached by the clinical team (either surgical or oncology) and provided with information about the trial. Surgical It is expected that approximately 80% of patients will require surgery before radiotherapy. Informed consent will be taken and eligibility will be confirmed by appropriate members of the surgical team. The surgery itself is part of standard c
Current inclusion criteria as of 31/10/2024: 1. Written and informed consent obtained from participants 2. Agreement of participant to comply with the requirements of the trial, including travel and residential stay at the proton centre if allocated to PBT 3. Histologically confirmed: 3.1. Sinonasal squamous cell carcinoma (SNSCC) or 3.2. Sinonasal adenocarcinoma (SNAC) 4. Primary tumour (T) staging (AJCC 8th edition): 4.1. T3-4 all subsites (maxillary, ethmoid, sphenoid or frontal sinuses, and/or nasal cavity) or 4.2. T2 nasal cavity involving ethmoid sinus 5. Age >=25 years old 6. WHO performance status 0-1 7. Multidisciplinary team (MDT) decision for curative intent treatment 7.1. with surgery or 7.2. without _____ Previous inclusion criteria: 1. Written and informed consent obtained from participants 2. Agreement of participant to comply with the requirements of the trial, including travel and residential stay at the proton centre if allocated to PBT 3. Histologically confirmed: 3.1. Sinonasal squamous cell carcinoma (SNSCC) or 3.2. Sinonasal adenocarcinoma (SNAC) 4. Primary tumour (T) staging (AJCC 8th edition): 4.1. T3-4 all subsites (maxillary, ethmoid, sphenoid or frontal sinuses, and/or nasal cavity) or 4.2. T2 nasal cavity involving ethmoid sinus 5. Age > = 16 years old 6. WHO performance status 0-1 7. Multidisciplinary team (MDT) decision for curative intent treatment 7.1. with surgery or 7.2. without
1. Distant metastatic disease, as determined by routine pre-operative radiological staging investigations 2. Previous head and neck radiotherapy 3. Any invasive malignancy within the previous 2 years (other than non-melanomatous skin carcinoma or cervical carcinoma in situ) 4. Previous or concurrent illness that would interfere with completion of therapy, trial assessments or follow-up (in the opinion of PI) 5. Pregnant or breastfeeding women 6. Participants unwilling or unable to use adequate non-hormonal contraception