Can proton beam therapy improve survival and reduce late side effects compared with standard-of-care intensity-modulated radiotherapy in patients with sinonasal cancer?

Not Applicable

• Conditions: on-metastatic sinonasal cancer; Cancer

• Registration Number: ISRCTN15983654
• Lead Sponsor: The Christie NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-26
• Last Update Posted: 2 September 2024
• Study Completion: 2031-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 276

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-free survival (DFS) measured using a biopsy; a biopsy with pathological confirmation will define a DFS event. Where a biopsy is not possible, correlative imaging can be used as a surrogate to define a DFS event from randomisation to cancer recurrence, death from any cause, or 5-year follow-up.