Clinical trial · Observational
State of the Art Photon Therapy Versus Particle Therapy for Recurrent Head & Neck Tumors; a Planning Study
In Silico Clinical Trial, Comparing State of the Art Photon Modalities With Proton and C-ion Therapy for Recurrent Head & Neck Tumors: A Multicentric Planning Study From the ROCOCO (Radiation Oncology COllaborative COmparison) Group
- 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)
Given that the cost of proton therapy is considerably higher than that of conventional radiotherapy with photons, it is necessary to establish whether these higher costs are worthwhile in light of the expected advantages2,3,4. Thus, clear evidence of the situations in which proton therapy outperforms conventional photon treatment is needed. The investigators therefore aim to demonstrate through an in silico trial that proton therapy decrease the amount of irradiated normal tissue and, consequently, the risk of side effects in the surrounding normal tissue as well as the risk of secondary tumors. The same overall treatment time and an equal number of fractions will be used for both treatment modalities wherever possible. The most optimal technique for each individual patient, based on objective criteria related to limiting dose to normal tissue, will be prescribed by the institution concerned for each treatment option.
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 |
|---|---|---|---|
| Carcinoma, Squamous Cell of Head and Neck | Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Photon therapy versus C-ion therapy | Radiation | — | UNRESOLVED |
| Photon therapy versus proton therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with recurrent HN tumors
- description
- Patients with recurrent Head and Neck tumors
- interventionNames
- Radiation: Photon therapy versus proton therapy
- Radiation: Photon therapy versus C-ion therapy
Primary outcomes (1)
- measure
- Radiation exposure for organs at risk in H&N cancer patients
- timeFrame
- 7 weeks
- description
- Radiation exposure for organs at risk in H\&N patients treated with radiotherapy for recurrent tumors after primary radiotherapy. Results are based on in silico planning study which compares photon, proton and Carbon-ion treatments. The same biological radiation dose, fractionation schedule and tumor dose inhomogeneity is used. A wide range of OAR is included in this study, to be able to document doses to organs that are further away from the target volume, and also to quantify low doses to organs.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Primary treatment: 1. ≥ 50 Gy with curative intent (with or without chemo) 2. CTV includes primary tumor and at least level II-IV 3. Severe dental scatter artifacts or metal implants of unknown density will be excluded 4. IMRT plan available * Secondary treatment after ≥ 1 year, dose 70 Gy a. Severe dental scatter artifacts or metal implants of unknown density will be excluded * Overlap of at least one OAR in primary and secondary treatment Exclusion Criteria: * Patients referred for postoperative radiotherapy
References
Publications (0)
Data not yet available