The goal of this observational study is to evaluate the toxicity and local tumor control of proton therapy for patients with head and neck cancer in a previously irradiated field.
Standard of care for recurrent or secondary malignancies in a previously irradiated field is surgery. For inoperable patients or residual tumor after surgery, standard of care would be palliative chemotherapy. For a small subset of patients (good performance status, small radiation fields) re-irradiation can be performed. In this study the established concept of re-irradiation with photons will be transferred to proton radiotherapy. Proton therapy has the advantage of a steeper dose gradient to normal tissues, thus-theoretical advantages for lower toxicity.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* tumor is located in a previously irradiated area with at least 50 Gy or there is an overlap of radiation fields with resulting total doses greater than 90 Gy to expect
* tumor size and localization allow high dose re-irradiation (individual decision)
* exclusion of distant metastases
* Time interval between pre-irradiation and re- irradiation at least 1 year for local recurrence; at least 6 months for secondary tumor disease
* age ≥ 18 years
* previous radiotherapy treatment plans available
* pre-treatment imaging (pre re-irradiation) available
* good general condition (ECOG 0-1)
* dental treatment performed, if necessary
* in case of surgery before re-irradiation: resection status is R-1 or R-2
* clinical suspicion of residual tumor by very scarce surgical margins (\<1 mm)
* pathological secured extracapsular extension (ECE)
* indications by an interdisciplinary tumor board
* patient able to understand the intention and procedures of the trial, written informed consent
Exclusion Criteria:
* no description of the R- status after resection of the tumour
* pregnancy
* no written informed consent
* distant metastases
* interval between first and second irradiation \< 6 months at secondary tumor or \<1 year when local recurrence of previously irradiated tumor
* simultaneous participation in another intervention study , if further treatment must be carried out
Primary outcome measure(s)
late toxicity — 24 months after therapy measured from the first day of treatment
Trial sites (1)
Facility
City
Region
Status
Dresden University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology; and DKTK partner site Dresden
Dresden
Saxony
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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.
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