Clinical trial · Interventional
Carbon Ion Re-Radiotherapy in Patients With Recurrent or Progressive Locally Advanced Head-and-Neck Cancer
Carbon Ion Re-Radiotherapy in Patients With Recurrent or Progressive Locally Advanced Head-and-Neck Cancer: A Phase-II Study to Evaluate Toxicity and Efficacy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Head-and-Neck Cancer | Malignant Head and Neck Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| C12 re-irradiation | Radiation | — | UNRESOLVED |
| Photon re-irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- C12 irradiation
- description
- Evaluation of Safety and Toxicity of C12 ion reirradiation
- interventionNames
- Radiation: C12 re-irradiation
- type
- ACTIVE_COMPARATOR
- label
- Photon irradiation
- description
- Evaluation of Safety and Toxicity of photon re-irradiation
- interventionNames
- Radiation: Photon re-irradiation
Primary outcomes (2)
- measure
- safety of carbon ion re-irradiation
- timeFrame
- 6 month
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHeld T, Lang K, Regnery S, Weusthof K, Hommertgen A, Jakel C, Tonndorf-Martini E, Krisam J, Plinkert P, Zaoui K, Freudlsperger C, Moratin J, Krauss J, Harrabi SB, Herfarth K, Debus J, Adeberg S. Carbon ion reirradiation compared to intensity-modulated re-radiotherapy for recurrent head and neck cancer (CARE): a randomized controlled trial. Radiat Oncol. 2020 Aug 5;15(1):190. doi: 10.1186/s13014-020-01625-0. PMID 32758267