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

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.

Eligibility

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

Conditions2

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