Carbon Ion Re-Radiotherapy in Patients With Recurrent or Progressive Locally Advanced Head-and-Neck Cancer

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT04185974

Studienbeginn:
August 2020

Letztes Update:
05.01.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Head and Neck Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital Heidelberg

Collaborator:
-

Kontakt

Sebastian Adeberg, PD
Kontakt:
Phone: 49 622156
Phone (ext.): 35754
E-Mail: sebastian.adeberg@med.uni-heidelberg.de» Kontaktdaten anzeigen

Hommertgen Adriane, PhD
Kontakt:
Phone: 49 622156
Phone (ext.): 34091
E-Mail: adriane.hommertgen@med.uni-heidelberg.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Hospital of Heidelberg, Radiation Oncology
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Jürgen Debus, Prof. Dr.
Phone: +49-6221-56
Phone (ext.): 8202
E-Mail: juergen.debus@med.uni-heidelberg.de

Adriane Hommertgen
Phone: +49-6221-56
Phone (ext.): 34091
E-Mail: adriane.hommertgen@med.uni-heidelberg.de» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

The incidence of head-and-neck cancer worldwide amounts to around 550.000 cases per year,

with male patients affected significantly more often. Common risk factors are smoking,

alcohol, viral infections, immunodeficiency or genetic factors. Locally advanced

head-and-neck tumors can lead to severe symptoms such as dysphagia, cachexia and tumor pain

with a significant decrease of the quality-of-life. The prognosis depends on multiple factors

such as TNM-staging, tumor volume, histology, general condition, age and smoking. Further

risk factors are positive resection margins, extracapsular extension and perineural invasion.

While metastatic spread significantly decreases overall survival, the life-limiting problem

in patients with head-and-neck cancer is locally invasive and destructive tumor growth

leading to a decrease of the performance status and quality of life. After multimodal therapy

of locally advanced head-and-neck tumors, around 30 - 50% of patients will develop local

recurrence or locally progressive disease and up to 8% of patients with HNSCC will develop a

second primary tumor in the head-and-neck .

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Locally recurrent / progressive head-and-neck cancer after initial radiation therapy

- Microscopic or macroscopic tumor after salvage surgery

- Indication for re-irradiation

- Completed wound healing after surgical intervention

- Karnofsky-Performance-Score ≥ 60

- Age ≥ 18 years

- Written informed consent (must be available before enrolment in the trial)

- Ability of subject to understand character and individual consequences of the trial

- For women with childbearing potential, (and men) adequate contraception

- Submission of previous radiotherapy records

Exclusion Criteria:

- Re-irradiation of malignancy in the larynx

- Diagnosed plasmocytoma, sarcoma or chordoma

- Previous re-irradiation in-field

- Time interval < 6 months after initial radiotherapy

- Distant metastases (except pulmonary metastases)

- Patients who have not recovered from acute toxicities of prior therapies

- Refusal of the patients to take part in the study

- Pregnant or lactating women

- Known carcinoma <5 years ago (excluding Carcinoma in situ of the cervix, basal cell

carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment

interfering with study therapy

- Participation in another clinical study or observation period of competing trials,

respectively

Studien-Rationale

Primary outcome:

1. safety of carbon ion re-irradiation (Time Frame - 6 month):
the rate of patients with an acute/subacute toxicity CTCAE v5.0 ≥ grade 3

2. toxicity of carbon ion re-irradiation (Time Frame - 6 month):
the rate of patients with an acute/subacute toxicity CTCAE v5.0 ≥ grade 3

Secondary outcome:

1. progression-free survival (Time Frame - 12 month):
Local progression-free survival

2. Overall survival (Time Frame - 12 month):
within 12 month after re-irradiation

3. Score on EORTC QLQ C30 Quality of life questionaire (Time Frame - within 12 month after re-irradiation):
EORTC (European Organization for Research and. Treatment of Cancer) QLQ (quality of life questionnaire) C30, score 1-6, high score means worse outcome

4. Score on EORTC QLQ H&N35 Quality of life questionaire (Time Frame - within 12 month after re-irradiation):
QLQ (quality of life questionnaire)-H&N (Head and neck) 35, score 1-6, high score means worse outcome

Studien-Arme

Experimental: C12 irradiation
Evaluation of Safety and Toxicity of C12 ion reirradiation
Active Comparator: Photon irradiation
Evaluation of Safety and Toxicity of photon re-irradiation

Geprüfte Regime

C12 re-irradiation:
51 Gy(RBE) or 54 Gy
Photon re-irradiation:
54 Gy(RBE) or 60 Gy

Quelle: ClinicalTrials.gov

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