Re-irradiation of Recurrent Head and Neck Cancer (ReKo)
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|ClinicalTrials.gov Identifier: NCT01973179|
Recruitment Status : Recruiting
First Posted : October 31, 2013
Last Update Posted : July 26, 2017
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 or disease||Intervention/treatment|
|Head-and-neck Carcinoma||Radiation: Radiation therapy|
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 Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Observational Study to Re-irradiation for Recurrent Head and Neck Cancer|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||August 2022|
|Estimated Study Completion Date :||August 2023|
Radiotherapy with protons in patients with head and neck carcinoma
Radiation: Radiation therapy
Radiation therapy with protons
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973179
|Contact: Mechthild Krause, Prof.||Mechthild.Krause@uniklinikum-dresden.de|
|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|