Proton Versus Photon Therapy in Head and Neck Squamous Cell Carcinomas.
Recruiting
Phase 3
Interventional Study
HNSCC
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 40 – 90
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 400 (estimated)
- Sponsor
- Oslo University Hospital · Other
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About This Trial
A national, randomized, clinical trial (phase III) investigating radiotherapy with protons compared with photons for patients with squamous cell carcinoma of the head and neck area eligible for radiotherapy, either radical or postoperative, with curative intent. Comparative dose plans with protons and photons will be prepared, and the probability of toxicity evaluated with NTCP models. Patients wi…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Signed informed consent.
2. Age ≥ 40 years.
3. Histological or cytological verified squamous cell carcinoma of the following head and neck regions; oral cavity, oropharynx, hypopharynx or larynx.
4. Planned for standard radiotherapy with curative intent, either as definitive …
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