Not a traditional drug phase: Proton Beam Therapy for Parotid Cancer
Proton Beam Therapy (PBT) is an advanced radiotherapy technique. There are two National Health Service (NHS) PBT treatment centres in the UK, one in Manchester and one in London.
Official registry: https://clinicaltrials.gov/study/NCT06421649 · The Christie NHS Foundation Trust · enrollment listed as 97
What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Proton Beam Therapy. The registry lists allocation as na. Proton Beam Therapy (PBT) is an advanced radiotherapy technique.
They plan to enroll about 97 people at 2 sites. Taking part typically means a procedure as part of the study plus check-ins.
Official title (unrewritten)
An Evaluative Commissioning Study to Investigate the Role of Adjuvant Proton Beam Radiotherapy in Patients With Localised Parotid Carcinoma
Interventions: Proton Beam Therapy
Primary outcome (registry wording): Taste dysfunction
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- Histologically confirmed primary malignant tumours of parotid gland
- Requiring post-operative radiotherapy to the parotid bed, with a dose equivalent of at least 60 Gray (Gy) in 2 Gy / fraction
- Treatment delivered with radical intent
- All patients must be suitable to attend regular follow-up, audiograms, toxicity monitoring, and be available for long term follow-up
- Willingness to comply with the protocol, including travel to the proton centre for Intensity Modulated Proton Therapy (IMPT) treatment
Who the registry excludes
- Previous radiotherapy to the head and neck region;
- Parotid tumours requiring primary radiation or those with gross residual disease;
- Metastases from squamous cell carcinoma of the head and neck to the parotid gland;
- Benign tumours requiring post operative radiotherapy;
- Previous or concurrent illness, which in the investigators opinion would interfere with either completion of therapy or follow-up;
- Patients requiring or receiving neoadjuvant, concomitant or planned adjuvant chemotherapy
- Patients who are eligible for PBT under routine commissioning
Public study contact (from the registry)
Romelie Rieu
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
2 listed- University College London Hospitals NHS Foundation Trust — London, United Kingdom (recruiting)
- The Christie NHS Foundation Trust — Manchester, United Kingdom (recruiting)
FAQ about this NCT record
Is NCT06421649 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06421649?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06421649?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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