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

  • STATUS
    Recruiting
  • End date
    Nov 30, 2024
  • participants needed
    72
  • sponsor
    University Hospital Heidelberg
Updated on 25 January 2021

Summary

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.

Description

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 .

Details
Condition Locally Advanced Head and Neck Cancer
Treatment C12 re-irradiation, Photon re-irradiation
Clinical Study IdentifierNCT04185974
SponsorUniversity Hospital Heidelberg
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Locally Advanced Head and Neck Cancer?
Do you have any of these conditions: Do you have Locally Advanced Head and Neck Cancer??
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
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