NCT04185974Recruiting
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 · Last updated 25 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- First submitted
- 25 Nov 2019
- Start date
- 25 Aug 2020
- Primary completion date
- 30 Jul 2030
- Lead sponsor
- University Hospital Heidelberg
- Diseases
- Head and neck cancer
- NCT number
- NCT04185974
What you commit to
- Study type: Interventional
- Planned participants: 72
- From 25 Aug 2020 to the primary completion date, 30 Jul 2030
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous re-irradiation in-field
- Time interval \< 6 months after initial radiotherapy
- Patients who have not recovered from acute toxicities of prior therapies
Other illness
- Re-irradiation of malignancy in the larynx
Age
- 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
Other
- Diagnosed plasmocytoma, sarcoma or chordoma
- Distant metastases (except pulmonary metastases)
- Refusal of the patients to take part in the study
- Pregnant or lactating women
- Participation in another clinical study or observation period of competing trials, respectively
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital of Heidelberg, Radiation Oncology Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
| Philips University Marburg Coordinator of this site? Confirm its status | Marburg | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.