Carbon Ion Re-Radiotherapy in Patients With Recurrent or Progressive Locally Advanced Head-and-Neck Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Heidelberg
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Re-irradiation of malignancy in the larynx
Diagnosed plasmocytoma, sarcoma or chordoma
Previous re-irradiation in-field
Time interval < 6 months after initial radiotherapy
Trial design
Design model
Parallel
Treatments tested in this trial
C12 re-irradiation
Radiation51 Gy(RBE) or 54 Gy
Photon re-irradiation
Radiation54 Gy(RBE) or 60 Gy
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: C12 irradiationExperimental treatment 1 intervention
Group B: Photon irradiationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
safety of carbon ion re-irradiation
the rate of patients with an acute/subacute toxicity CTCAE v5.0 ≥ grade 3
Time frame
6 month2
toxicity of carbon ion re-irradiation
the rate of patients with an acute/subacute toxicity CTCAE v5.0 ≥ grade 3
Time frame
6 monthSecondary outcomes
1
progression-free survival
Local progression-free survival
Time frame
12 month2
Overall survival
within 12 month after re-irradiation
Time frame
12 month3
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
Time frame
within 12 month after re-irradiation4
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
Time frame
within 12 month after re-irradiationSponsors and contacts
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Source ClinicalTrials.gov