Carbon Ion Re-Radiotherapy in Patients With Recurrent or Progressive Locally Advanced Head-and-Neck Cancer (CARE)
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ClinicalTrials.gov Identifier: NCT04185974 |
Recruitment Status :
Recruiting
First Posted : December 4, 2019
Last Update Posted : October 6, 2021
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Locally Advanced Head-and-Neck Cancer | Radiation: C12 re-irradiation Radiation: Photon re-irradiation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 72 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | August 25, 2020 |
Estimated Primary Completion Date : | November 30, 2024 |
Estimated Study Completion Date : | November 30, 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: C12 irradiation
Evaluation of Safety and Toxicity of C12 ion reirradiation
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Radiation: C12 re-irradiation
51 Gy(RBE) or 54 Gy |
Active Comparator: Photon irradiation
Evaluation of Safety and Toxicity of photon re-irradiation
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Radiation: Photon re-irradiation
54 Gy(RBE) or 60 Gy |
- 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
- progression-free survival [ Time Frame: 12 month ]Local progression-free survival
- Overall survival [ Time Frame: 12 month ]within 12 month after re-irradiation
- Score on EORTC QLQ C30 Quality of life questionaire [ Time Frame: within 12 month after re-irradiation ]EORTC (European Organization for Research and. Treatment of Cancer) QLQ (quality of life questionnaire) C30, score 1-6, high score means worse outcome
- Score on EORTC QLQ H&N35 Quality of life questionaire [ Time Frame: within 12 month after re-irradiation ]QLQ (quality of life questionnaire)-H&N (Head and neck) 35, score 1-6, high score means worse outcome

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04185974
Contact: Sebastian Adeberg, PD | 49 622156 ext 35754 | sebastian.adeberg@med.uni-heidelberg.de | |
Contact: Hommertgen Adriane, PhD | 49 622156 ext 34091 | adriane.hommertgen@med.uni-heidelberg.de |
Germany | |
University Hospital of Heidelberg, Radiation Oncology | Recruiting |
Heidelberg, Germany, 69120 | |
Contact: Jürgen Debus, Prof. Dr. +49-6221-56 ext 8202 juergen.debus@med.uni-heidelberg.de | |
Contact: Adriane Hommertgen +49-6221-56 ext 34091 adriane.hommertgen@med.uni-heidelberg.de |
Responsible Party: | Juergen Debus, Head of department, University Hospital Heidelberg |
ClinicalTrials.gov Identifier: | NCT04185974 |
Other Study ID Numbers: |
RADONK-CARE-2018 |
First Posted: | December 4, 2019 Key Record Dates |
Last Update Posted: | October 6, 2021 |
Last Verified: | September 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Head and Neck Neoplasms Neoplasms by Site Neoplasms |