NCT01973179Active, not recruiting
Re-irradiation of Recurrent Head and Neck Cancer
Observational Study to Re-irradiation for Recurrent Head and Neck Cancer
Source: ClinicalTrials.gov · Last updated 6 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 25 Oct 2013
- Start date
- Jul 2015
- Primary completion date
- Sept 2026
- Lead sponsor
- Technische Universität Dresden
- Diseases
- Head and neck cancer
- NCT number
- NCT01973179
What you commit to
- Study type: Observational
- Planned participants: 50
- From Jul 2015 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- no description of the R- status after resection of the tumour
- interval between first and second irradiation \< 6 months at secondary tumor or \<1 year when local recurrence of previously irradiated tumor
Other
- pregnancy
- no written informed consent
- distant metastases
- simultaneous participation in another intervention study , if further treatment must be carried out
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dresden University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology; and DKTK partner site Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.