Clinical trial · Interventional
DAHANCA 37. Re-irradiation With Proton Radiotherapy
DAHANCA 37 A Phase II Study of Intensity Modulated Proton Therapy (IMPT) for Re-irradiation With Curative Intent for Recurrent or New Primary 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)
Summary Design Phase II observational Treatment * 60 Gy/50 fx / 10W-1 at 1.2 Gy/fx o i.e. EQD2 tumor=56 Gy, EQD2 late=50.4 Gy at α/β= 10 and 3, respectively * Proton radiotherapy * Concomitant cisplatin for eligible patients\* * Nimorazole recommended for SCC\* \*The concurrent medical treatment (weekly cisplatin and nimorazole) are prescribed according to the national treatment guidelines, and are not part of the experimental treatment. Endpoints * Primary: o Any new late toxicity grade \>=3 according to CTC AE 5.0 * Secondary * Side effects according to DAHANCA scoring system * Quality of life and PROM according to EORTC C30 and HN43 * Loco-regional control (LRC) * Overall survival (OS)
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 Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Re-irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Re-Irradiation with protons
- description
- 60 Gy in 50 fraktions, 10 weekly with protons
- interventionNames
- Radiation: Re-irradiation
Primary outcomes (1)
- measure
- Any new grade >=3 toxicity
- timeFrame
- 3 years after radiotherapy
- description
- CTC AE 5.0
Secondary outcomes (4)
- measure
- Side effects, any grade
- timeFrame
- 5 years after radiotherapy
- description
- According to CTC AE or Dahanca
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological verified loco-regional recurrence or new primary * Available dose plan from primary radiotherapy course * Comparative dose plan with advantages for proton radiotherapy e.g. integral dose * Dmax dose (0.03 cm3) on the cumulated photon dose plan≥90 Gy * Complete Response (CR)\* after initial therapy, except in the case where the recurrence is considered a geometric miss (recurrence center of mass (COM) outside the 95% of prescription dose. * Inoperable or salvage surgery with R1/R2 resection, extranodal extension (ENE) or extensive soft tissue infiltration * Absence of distant metastasis at both * clinical examination AND * PET-CT or CT of thorax and upper abdomen * Life expectancy due to age and co-morbidity of \>=1 year. The general condition must be sufficient to tolerate persistent significant side effects, e.g. tube or cannulae * PS\<=2 (WHO See appendix) Exclusion Criteria: * Radical surgery (R0) and absence of adverse prognostic pathological features * Lymphoma or malignant melanoma * Inability to attend full course of radiotherapy or follow-up visits in the outpatient clinic * As of 2019, patients with tracheal cannulas are excluded due to dose uncertainties. This may change if a technical solution becomes available.
References
Publications (0)
Data not yet available