Actively Recruiting
Carbon Ion Re-Radiotherapy in Patients With Recurrent or Progressive Locally Advanced Head-and-Neck Cancer
Led by University Hospital Heidelberg · Updated on 2026-03-25
72
Participants Needed
2
Research Sites
544 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Carbon Ion Re-Radiotherapy in Patients With Recurrent or Progressive Locally Advanced Head-and-Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Locally recurrent or progressive head-and-neck cancer after initial radiation therapy
- Microscopic or macroscopic tumor present after salvage surgery
- Indication for re-irradiation
- Completed wound healing after surgery
- Karnofsky Performance Score of 60 or higher
- Age 18 years or older
- Written informed consent provided
- Ability to understand the trial and its consequences
- Adequate contraception for women of childbearing potential and men
- Submission of previous radiotherapy records
You will not qualify if you...
- Re-irradiation of malignancy in the larynx
- Diagnosed plasmocytoma, sarcoma, or chordoma
- Previous re-irradiation in the same field
- Less than 6 months since initial radiotherapy
- Presence of distant metastases except for lung metastases
- Not recovered from acute toxicities of prior therapies
- Refusal to participate in the study
- Pregnant or breastfeeding women
- Known carcinoma within the last 5 years requiring immediate treatment, except certain skin and cervical cancers
- Participation in other clinical studies or observation periods of competing trials
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University Hospital of Heidelberg, Radiation Oncology
Heidelberg, Germany, 69120
Actively Recruiting
2
Philips University Marburg
Marburg, Germany, 35037
Actively Recruiting
Research Team
H
Held Thomas, PD Dr.
CONTACT
C
Cornelia Jäkel, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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