Clinical trial · Interventional
Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Head and Neck Cancer
A Phase II Randomized Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Unilateral Head and Neck Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Compared to IMRT, PBRT is thought to give less radiation exposure to the surrounding healthy tissues. It is possible that side effect rates with PBRT will be lower or the same compared to IMRT, but this has not been well studied to date. Although both of these radiation therapies have been used in the past to treat head and neck cancer, this research study will compare the effects of these two different radiation treatment modalities with each other to see whether PBRT is better, the same or worse than IMRT.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Photon intensity modulated radiation therapy (IMRT) | Radiation | — | UNRESOLVED |
| Proton beam radiotherapy (PBRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Photon intensity modulated radiation therapy (IMRT)
- description
- IMRT to standard dose of 60-66Gy
- interventionNames
- Radiation: Photon intensity modulated radiation therapy (IMRT)
- type
- EXPERIMENTAL
- label
- Proton beam radiotherapy (PBRT)
- description
- PBRT to standard dose of 60-66Gy
- interventionNames
- Radiation: Proton beam radiotherapy (PBRT)
Primary outcomes (1)
- measure
- number of patients with grade 2 or greater acute mucositis
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age greater than or equal to 18. * Histopathologically confirmed diagnosis of one the following cancer types: * Salivary gland cancer * Skin cancer * Melanoma * HNSCC that require ipsilateral radiation * Patients must be a candidate for ipsilateral radiation therapy. * Karnofsky performance status ≥70. * Negative pregnancy test for women of childbearing potential (\<51 years of age) as per institutional policy. Exclusion Criteria: * Any prior head or neck irradiation. * Physician recommendation of bilateral neck radiation. * Non-resectable disease * Physician recommendation of mucosal radiation
References
Publications (1)
- Source
- PubMed (NLM)
- Dataset
- PubMed E-utilities
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
Edward Christopher Dee, Noah S Kalman, Daniel J Ma et al. · J Natl Cancer Inst · Sep 3, 2026 · PMID 42690689 pubmed