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Re-irradiation of Recurrent Head and Neck Cancer (ReKo)
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Purpose
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.
| Condition | Intervention |
|---|---|
| Head-and-neck Carcinoma | Radiation: Radiation therapy |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Observational Study to Re-irradiation for Recurrent Head and Neck Cancer |
- late toxicity [ Time Frame: 24 months after therapy ]measured from the first day of treatment
- acute toxicity [ Time Frame: 3 months after treatment ]measured from the first day of treatment
- local recurrence free survival [ Time Frame: 24 months after therapy ]measured from the first day of treatment
- overall survival [ Time Frame: 24 months after therapy ]measured from the first day of treatment
- quality of life [ Time Frame: 24 months after therapy ]measured from the first day of treatment
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2015 |
| Estimated Study Completion Date: | August 2023 |
| Estimated Primary Completion Date: | August 2022 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Radiation therapy
Radiotherapy with protons in patients with head and neck carcinoma
|
Radiation: Radiation therapy
Radiation therapy with protons
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01973179
| Contact: Mechthild Krause, Prof. | Mechthild.Krause@uniklinikum-dresden.de |
| Germany | |
| Dresden University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology; and DKTK partner site Dresden | Recruiting |
| Dresden, Saxony, Germany, 01307 | |
| Contact: Mechthild Krause, Prof. Mechthild.Krause@uniklinikum-dresden.de | |
| Principal Investigator: Mechthild Krause, Prof. | |
| Study Chair: | Mechthild Krause, Prof. | Dresden University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology; and DKTK partner site Dresden |
More Information
| Responsible Party: | Mechthild Krause, Prof. Dr. med., Technische Universität Dresden |
| ClinicalTrials.gov Identifier: | NCT01973179 History of Changes |
| Other Study ID Numbers: |
STR-ReKo-2013 |
| Study First Received: | October 25, 2013 |
| Last Updated: | January 19, 2017 |
| Individual Participant Data | |
| Plan to Share IPD: | No |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Neoplasms by Site Neoplasms |
ClinicalTrials.gov processed this record on June 27, 2017