Clinical trial · Interventional
Proton Boost for Locally Advanced HEAD AND NECK TUMORS
Phase II Clinical Study on Proton Therapy Boost (Hadrontherapy) for Locally Advanced HEAD AND NECK TUMORS
NCT03183271CI-TRIAL-00028120completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The aim of this research project is to test the local response and the acute toxicity (which can be observed within 90 days).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epithelial Tumor, Malignant | Carcinoma | ALIAS | 0.90 |
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| external beam proton radiation therapy. | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental: External beam radiotherapy
- description
- A total of 20 patients will be irradiated with protons after photon IMRT
- interventionNames
- Radiation: external beam proton radiation therapy.
Primary outcomes (2)
- measure
- Local response
- timeFrame
- 90 days
- description
- RECIST criteria
- measure
- Acute toxicity
- timeFrame
- 90 days
- description
- According to CTCAE v4.0
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic/cytologic diagnosis of primary epithelial malignant or neuroendocrine tumour * Inoperable tumour, locally advanced stage * Seated in rhinopharynx, nasal and paranasal sinuses, hypopharynx, larynx, oral cavity and oropharynx * At least one lesion measured according to the RECIST criteria * Enrollment for irradiation with IMRT up to 50-60 Gy RBE\] on the PTV1rx and PTV2 rx to be followed at CNAO with irradiation with proton boost on thePTV1rx. Exclusion Criteria: * Metastasis * Previous radiotherapy * Any metallic implants or other conditions such to prevent an adequate imaging of target volume * Unavailability of previous IMRT first phase radiotherapy plans
References
Publications (0)
Data not yet available
No reference posted for this study.