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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Heidelberg

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Re-irradiation of malignancy in the larynx

Diagnosed plasmocytoma, sarcoma or chordoma

Previous re-irradiation in-field

Time interval < 6 months after initial radiotherapy

Trial design

Treatments tested in this trial

  • C12 re-irradiation
  • Photon re-irradiation

Treatment groups

72 Participants
are divided into 2 treatment groups

Sponsors and collaborators