Carbon Ion Re-Radiotherapy in Patients With Recurrent or Progressive Locally Advanced Head-and-Neck Cancer

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 .

Inclusion criteria

• Locally recurrent / progressive head-and-neck cancer after initial radiation therapy
• Microscopic or macroscopic tumor after salvage surgery
• Indication for re-irradiation
• Completed wound healing after surgical intervention
• Karnofsky-Performance-Score ≥ 60
• Age ≥ 18 years
• Written informed consent (must be available before enrolment in the trial)
• Ability of subject to understand character and individual consequences of the trial
• For women with childbearing potential, (and men) adequate contraception
• Submission of previous radiotherapy records

Exclusion criteria

• Re-irradiation of malignancy in the larynx
• Diagnosed plasmocytoma, sarcoma or chordoma
• Previous re-irradiation in-field
• Time interval < 6 months after initial radiotherapy
• Distant metastases (except pulmonary metastases)
• Patients who have not recovered from acute toxicities of prior therapies
• Refusal of the patients to take part in the study
• Pregnant or lactating women
• Known carcinoma <5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy
• Participation in another clinical study or observation period of competing trials, respectively