Carbon Ion Re-Radiotherapy in Patients With Recurrent or Progressive Locally Advanced Head-and-Neck Cancer

NCT04185974 · tracked via the Priya Life Science Germany tracker

Sponsor

University Hospital Heidelberg

Phase

Not applicable

Started

2020-08-25

Last updated

2026-03-25

Condition(s) studied

Locally Advanced Head-and-Neck Cancer

Investigational drug(s) / intervention(s)

C12 re-irradiationPhoton re-irradiation

C12 re-irradiation: 51 Gy(RBE) or 54 Gy

Photon re-irradiation: 54 Gy(RBE) or 60 Gy

Study 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. 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

safety of carbon ion re-irradiation — 6 month
the rate of patients with an acute/subacute toxicity CTCAE v5.0 ≥ grade 3
toxicity of carbon ion re-irradiation — 6 month
the rate of patients with an acute/subacute toxicity CTCAE v5.0 ≥ grade 3

Trial sites (2)

Facility	City	Region	Status
University Hospital of Heidelberg, Radiation Oncology	Heidelberg	Germany	Recruiting
Philips University Marburg	Marburg	Germany	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04185974 on ClinicalTrials.gov ↗ ← All trials in Germany