Locally Advanced Head-and-Neck CancerCARENCT04185974
Carbon Ion Re-Radiotherapy in Patients With Recurrent or Progressive Locally Advanced Head-and-Neck Cancer
A study testing C12 re-irradiation and Photon re-irradiation in people with Locally Advanced Head-and-Neck Cancer, run by University Hospital Heidelberg at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Head-and-Neck Cancer
- What is being tested?
- C12 re-irradiation and Photon re-irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesGermany
- Study dates
- 25 Aug 2020to 30 Jan 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
University Hospital of Heidelberg, Radiation Oncology
Heidelberg, 69120
Held Thomas, PD Dr., +49-6221-56 ext. 8202, thomas.held@med.uni-heidelberg.de
Cornelia Jäkel, Dr., +49-6221-56 ext. 34091, studienkoordination.rad@med.uni-heidelberg.de
- Recruiting
Philips University Marburg
Marburg, 35037
Sebastian Adeberg, Prof. Dr.
About this study
Official title: 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
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.
Read the detailed description
The incidence of head-and-neck cancer worldwide amounts to around 550.000 cases per year, with male patients affected significantly more often. Common risk factors are smoking, alcohol, viral infections, immunodeficiency or genetic factors. Locally advanced head-and-neck tumors can lead to severe symptoms such as dysphagia, cachexia and tumor pain with a significant decrease of the quality-of-life. The prognosis depends on multiple factors such as TNM-staging, tumor volume, histology, general condition, age and smoking. Further risk factors are positive resection margins, extracapsular extension and perineural invasion. While metastatic spread significantly decreases overall survival, the life-limiting problem in patients with head-and-neck cancer is locally invasive and destructive tumor growth leading to a decrease of the performance status and quality of life. After multimodal therapy of locally advanced head-and-neck tumors, around 30 - 50% of patients will develop local recurrence or locally progressive disease and up to 8% of patients with HNSCC will develop a second primary tumor in the head-and-neck .
- Conditions
- Locally Advanced Head-and-Neck Cancer
- Being tested
- C12 re-irradiation, Photon re-irradiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C12 re-irradiationRadiation
51 Gy(RBE) or 54 Gy
Photon re-irradiationRadiation
54 Gy(RBE) or 60 Gy
| Study group | Role | What they receive |
|---|---|---|
| C12 irradiation | Experimental | Evaluation of Safety and Toxicity of C12 ion reirradiation Receives: Radiation: C12 re-irradiation |
| Photon irradiation | Active comparator | Evaluation of Safety and Toxicity of photon re-irradiation Receives: Radiation: Photon re-irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety of carbon ion re-irradiation
the rate of patients with an acute/subacute toxicity CTCAE v5.0 ≥ grade 3
Measured: 6 month
toxicity of carbon ion re-irradiation
the rate of patients with an acute/subacute toxicity CTCAE v5.0 ≥ grade 3
Measured: 6 month
Secondary outcomes (4)
progression-free survival
Local progression-free survival
Measured: 12 month
Overall survival
within 12 month after re-irradiation
Measured: 12 month
Score on EORTC QLQ C30 Quality of life questionaire
EORTC (European Organization for Research and. Treatment of Cancer) QLQ (quality of life questionnaire) C30, score 1-6, high score means worse outcome
Measured: within 12 month after re-irradiation
Score on EORTC QLQ H&N35 Quality of life questionaire
QLQ (quality of life questionnaire)-H\&N (Head and neck) 35, score 1-6, high score means worse outcome
Measured: within 12 month after re-irradiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start25 Aug 2020
- Primary completion30 Jul 2030 (estimated)
- Study completion30 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Head-and-Neck CancerStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juergen Debus, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185974
- Sponsor's protocol ID
- RADONK-CARE-2018
- Acronym
- CARE
- Status last verified
- Mar 2026
- First submitted
- 25 Nov 2019
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Held 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.
PubMed 32758267
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04185974
- Acronym / sponsor ID
- CARE / RADONK-CARE-2018
- Conditions
- Locally Advanced Head-and-Neck Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 30 Jul 2030 (estimated)
- Study completion
- 30 Jan 2031 (estimated)
- First posted
- 4 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The incidence of head-and-neck cancer worldwide amounts to around 550.000 cases per year, with male patients affected significantly more often. Common risk factors are smoking, alcohol, viral infections, immunodeficiency or genetic factors. Locally advanced head-and-neck tumors can lead to severe symptoms such as dysphagia, cachexia and tumor pain with a significant decrease of the quality-of-life. The prognosis depends on multiple factors such as TNM-staging, tumor volume, histology, general condition, age and smoking. Further risk factors are positive resection margins, extracapsular extension and perineural invasion. While metastatic spread significantly decreases overall survival, the life-limiting problem in patients with head-and-neck cancer is locally invasive and destructive tumor growth leading to a decrease of the performance status and quality of life. After multimodal therapy of locally advanced head-and-neck tumors, around 30 - 50% of patients will develop local recurrence or locally progressive disease and up to 8% of patients with HNSCC will develop a second primary tumor in the head-and-neck .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| C12 irradiation | Experimental | Radiation: C12 re-irradiationEvaluation of Safety and Toxicity of C12 ion reirradiation |
| Photon irradiation | Active comparator | Radiation: Photon re-irradiationEvaluation of Safety and Toxicity of photon re-irradiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C12 re-irradiation51 Gy(RBE) or 54 Gy | Radiation | C12 irradiation |
| Photon re-irradiation54 Gy(RBE) or 60 Gy | Radiation | Photon irradiation |
Primary outcome
safety of carbon ion re-irradiation
Time frame: 6 month
the rate of patients with an acute/subacute toxicity CTCAE v5.0 ≥ grade 3
toxicity of carbon ion re-irradiation
Time frame: 6 month
the rate of patients with an acute/subacute toxicity CTCAE v5.0 ≥ grade 3
4 secondary outcomes
progression-free survival
Time frame: 12 month
Overall survival
Time frame: 12 month
Score on EORTC QLQ C30 Quality of life questionaire
Time frame: within 12 month after re-irradiation
Score on EORTC QLQ H&N35 Quality of life questionaire
Time frame: within 12 month after re-irradiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Derived from this study: PubMed 32758267Held 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C12 re-irradiation and Photon re-irradiation in people with Locally Advanced Head-and-Neck Cancer, run by University Hospital Heidelberg at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Held Thomas, PD Dr. (49 622156 ext. 8202, thomas.held@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety of carbon ion re-irradiation (time frame: 6 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04185974, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.