An interventional study of C12 re-irradiation and Photon re-irradiation in Locally Advanced Head-and-Neck Cancer, sponsored by University Hospital Heidelberg. Recruiting at 2 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-25.
Sponsored by University Hospital Heidelberg · Not applicable, Interventional, and Treatment
After multimodal therapy of head-and-neck tumors, patients often develop local recurrence, locally progressive disease or second primary tumors. In this highly pre-treated patient cohort, therapeutic options are limited. Patients that are not candidates for salvage surgery may benefit from re-irradiation. Despite recent technical advances, re-irradiation is associated with severe side effects. Carbon ion Re-Radiotherapy (reCIRT) has shown encouraging results in retrospective analyses with moderate toxicity.
In the current Phase-II CARE-trial, reCIRT and conventional photon re-irradiation in patients with recurrent or progressive locally advanced head-and-neck cancer will be assessed regarding toxicity/ safety, local progression-free survival, overall survival and quality-of-life.
The incidence of head-and-neck cancer worldwide amounts to around 550.000 cases per year, with male patients affected significantly more often. Common risk factors are smoking, alcohol, viral infections, immunodeficiency or genetic factors. Locally advanced head-and-neck tumors can lead to severe symptoms such as dysphagia, cachexia and tumor pain with a significant decrease of the quality-of-life. The prognosis depends on multiple factors such as TNM-staging, tumor volume, histology, general condition, age and smoking. Further risk factors are positive resection margins, extracapsular extension and perineural invasion. While metastatic spread significantly decreases overall survival, the life-limiting problem in patients with head-and-neck cancer is locally invasive and destructive tumor growth leading to a decrease of the performance status and quality of life. After multimodal therapy of locally advanced head-and-neck tumors, around 30 - 50% of patients will develop local recurrence or locally progressive disease and up to 8% of patients with HNSCC will develop a second primary tumor in the head-and-neck .
University Hospital Heidelberg is the lead sponsor of 175 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Evaluation of Safety and Toxicity of C12 ion reirradiation
Radiation: C12 re-irradiation
Evaluation of Safety and Toxicity of photon re-irradiation
Radiation: Photon re-irradiation
51 Gy(RBE) or 54 Gy
54 Gy(RBE) or 60 Gy
safety of carbon ion re-irradiation
the rate of patients with an acute/subacute toxicity CTCAE v5.0 ≥ grade 3
Time frame: 6 month
toxicity of carbon ion re-irradiation
the rate of patients with an acute/subacute toxicity CTCAE v5.0 ≥ grade 3
Time frame: 6 month
progression-free survival
Local progression-free survival
Time frame: 12 month
Overall survival
within 12 month after re-irradiation
Time frame: 12 month
Score on EORTC QLQ C30 Quality of life questionaire
EORTC (European Organization for Research and. Treatment of Cancer) QLQ (quality of life questionnaire) C30, score 1-6, high score means worse outcome
Time frame: within 12 month after re-irradiation
Score on EORTC QLQ H&N35 Quality of life questionaire
QLQ (quality of life questionnaire)-H\&N (Head and neck) 35, score 1-6, high score means worse outcome
Time frame: within 12 month after re-irradiation
Plan to share: No
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University Hospital Heidelberg