Re-irradiation of Recurrent Head and Neck Cancer

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT01973179

Studienbeginn:
Juli 2015

Letztes Update:
17.01.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Head and Neck Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Technische Universität Dresden

Collaborator:
-

Studienleiter

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

Kontakt

Mechthild Krause, Prof.
Kontakt:
E-Mail: Mechthild.Krause@uniklinikum-dresden.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Dresden University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology; and DKTK partner site Dresden
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Mechthild Krause, Prof.
E-Mail: Mechthild.Krause@uniklinikum-dresden.de» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. late toxicity (Time Frame - 24 months after therapy):
measured from the first day of treatment

Secondary outcome:

1. acute toxicity (Time Frame - 3 months after treatment):
measured from the first day of treatment

2. local recurrence free survival (Time Frame - 24 months after therapy):
measured from the first day of treatment

3. overall survival (Time Frame - 24 months after therapy):
measured from the first day of treatment

4. quality of life (Time Frame - 24 months after therapy):
measured from the first day of treatment

Geprüfte Regime

Radiation therapy:
Radiation therapy with protons

Quelle: ClinicalTrials.gov

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