Head-and-neck CarcinomaReKoNCT01973179
Re-irradiation of Recurrent Head and Neck Cancer
An observational study of Head-and-neck Carcinoma, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head-and-neck Carcinoma
- What is being tested?
- Radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2015to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a recurrent or secondary head and neck carcinoma
Who may be able to join
- 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)
Who cannot join
- 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
Show all 17Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dresden University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology; and DKTK partner site Dresden
Dresden, Saxony, 01307
About this study
Official title: Observational Study to Re-irradiation for Recurrent Head and Neck Cancer
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.
Read the detailed description
OBJECTIVES:
Primary: Evaluation of late toxicity of re-irradiation with protons, for patients with head and neck cancer in a previously (> 50 Gy) irradiated field.
Secondary: Evaluation of the efficacy (local control) and acute toxicity (after 24 Months) of re-irradiation with protons up to a dose of 60 Gy, for patients with head and neck cancer in a previously (> 50 Gy) irradiated field.
OUTLINE This is a single center observational study. In-house standard of care for patients (good performance status and with small tumors) with head and neck cancer in a previously (> 50 Gy) irradiated field is to irradiate the tumor with a hyperfractionated schedule and concurrent cisplatin up to a dose of 66 Gy. Dose limiting for this schedule is the incidence of acute and late toxicity induced by radiation. The purpose of the study is the evaluation of the safety of a treatment schedule based on the use of protons.
Proton beam treatments will be delivered in 2 Gy fractions, 5 days per week, to a total dose of 60-66 Gy equivalent.
Study visits are performed:
During proton therapy once per week. Follow-up visits are scheduled every 3 months for the first 24 months after proton therapy.
Primary endpoint is late toxicity 24 months after proton treatment.
- Conditions
- Head-and-neck Carcinoma
- Being tested
- Radiation therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation therapyRadiation
Radiation therapy with protons
| Study group | Role | What they receive |
|---|---|---|
| Radiation therapy | Radiotherapy with protons in patients with head and neck carcinoma Receives: Radiation: Radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
late toxicity
measured from the first day of treatment
Measured: 24 months after therapy
Secondary outcomes (4)
acute toxicity
measured from the first day of treatment
Measured: 3 months after treatment
local recurrence free survival
measured from the first day of treatment
Measured: 24 months after therapy
overall survival
measured from the first day of treatment
Measured: 24 months after therapy
quality of life
measured from the first day of treatment
Measured: 24 months after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2013 (estimated)
- Study startJul 2015
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head-and-neck CarcinomaStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mechthild Krause, Technische Universität Dresden
- Investigators
- Mechthild Krause, Prof., Study chair, Dresden University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology; and DKTK partner site Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973179
- Sponsor's protocol ID
- STR-ReKo-2013
- Acronym
- ReKo
- Status last verified
- Jan 2024
- First submitted
- 25 Oct 2013
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Re-irradiation for Recurrent Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT01973179
- Acronym / sponsor ID
- ReKo / STR-ReKo-2013
- Conditions
- Head-and-neck Carcinoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 31 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
Primary: Evaluation of late toxicity of re-irradiation with protons, for patients with head and neck cancer in a previously (> 50 Gy) irradiated field.
Secondary: Evaluation of the efficacy (local control) and acute toxicity (after 24 Months) of re-irradiation with protons up to a dose of 60 Gy, for patients with head and neck cancer in a previously (> 50 Gy) irradiated field.
OUTLINE This is a single center observational study. In-house standard of care for patients (good performance status and with small tumors) with head and neck cancer in a previously (> 50 Gy) irradiated field is to irradiate the tumor with a hyperfractionated schedule and concurrent cisplatin up to a dose of 66 Gy. Dose limiting for this schedule is the incidence of acute and late toxicity induced by radiation. The purpose of the study is the evaluation of the safety of a treatment schedule based on the use of protons.
Proton beam treatments will be delivered in 2 Gy fractions, 5 days per week, to a total dose of 60-66 Gy equivalent.
Study visits are performed:
During proton therapy once per week. Follow-up visits are scheduled every 3 months for the first 24 months after proton therapy.
Primary endpoint is late toxicity 24 months after proton treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation therapy | – | Radiation: Radiation therapyRadiotherapy with protons in patients with head and neck carcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a recurrent or secondary head and neck carcinoma
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation therapyRadiation therapy with protons | Radiation | Radiation therapy |
Primary outcome
late toxicity
Time frame: 24 months after therapy
measured from the first day of treatment
4 secondary outcomes
acute toxicity
Time frame: 3 months after treatment
local recurrence free survival
Time frame: 24 months after therapy
overall survival
Time frame: 24 months after therapy
quality of life
Time frame: 24 months after therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mechthild Krause, Prof. study chair
Dresden University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology; and DKTK partner site Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head-and-neck Carcinoma, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
late toxicity (time frame: 24 months after therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.