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

RecruitingNAAges 18 Years - anyAllUniversity Hospital Heidelberg
NCT04185974 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • C12 re-irradiation
  • Photon re-irradiation
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Where

2 sites
University Hospital of Heidelberg, Radiation Oncology
Heidelberg, Germany
Philips University Marburg
Marburg, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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