Clinical trial · Interventional
Individualized Response-adaptive Radiation Dose Prescription in HNC Based on MRI
Individualized Response-adaptive Radiation Dose Prescription in HNC Based on MRI - Real-time ADC-guided Response Adaptive Boost in HNC - "Individuelle MR-basierte Dosisverschreibung Bei Kopf-Hals-Tumoren - ADC-basierter Adaptiver Boost"
NCT05160714CI-TRIAL-00056268MRL-02unknownPhase 1ClinicalTrials.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)
This Phase 1 dose-finding study investigates the maximal tolerated dose for a subsequent phase 2 trial testing MR-guided individualized response-adaptive dose prescription in HNC.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Real-time ADC-guided response adaptive Boost in HNC | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Adaptive SBRT Boost
- description
- Dose-escalated SBRT boost to an ADC-based high risk subvolume in HNC
- interventionNames
- Radiation: Real-time ADC-guided response adaptive Boost in HNC
Primary outcomes (1)
- measure
- Dose limiting toxicity (DLT)
- timeFrame
- At 3 months after radiotherapy
- description
- Dose limiting toxicity (DLT): any acute and late grade 4 or 5 related to the intervention, ≥ grade 3 CTC v.5. oral mucositis at 3 months after radiotherapy (persistent mucosal ulceration or inflammation in the high dose region with severe pain; interfering with oral intake; limiting self-care ADL)
Secondary outcomes (2)
- measure
- Regional tumor control
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age: older than 18 years * WHO (ECOG) performance status 0-2 * Histological proven HNC (squamous cell carcinoma) * HPV negative tumors or high risk HPV positive tumors * Stage III - IVB HNC of the hypopharynx, oropharynx and oral cavity according to UICC and AJCC guidelines * Tumor extension and localization suitable for radiochemotherapy with curative intent * Simultaneous standard chemotherapy with cisplatin applicable (no contra-indications) * Dental examination and -treatment before start of therapy * For women with childbearing potential and men in reproductive ages adequate contraception. * Ability of subject to understand character and individual consequences of the clinical trial * Written informed consent (must be available before enrolment in the trial) Exclusion Criteria: * Refusal of the patients to take part in the trial * Presence of distant metastases (UICC stage IVC) * HPV positive tumors UICC Stage III with T1/2 N3, despite of smoking status * Previous radiotherapy in the head and neck region * Second malignancy that is likely to require treatment during the trial intervention or follow-up period or that, in the opinion of the physician, has a considerable risk of recurrence or metastases within the follow-up period * Serious disease or medical condition with life expectancy of less than one year * Participation in competing interventional trial on cancer treatment * Patients who are not suitable for radiochemotherapy * Pregnant or lactating women * Patients not able to understand the character and individual consequences of the trial * Nasopharyngeal and glottis laryngeal carcinomas * Patients with contraindications for magnet-resonance tomography
References
Publications (0)
Data not yet available
No reference posted for this study.