Individualized Response-adaptive Radiation Dose Prescription in HNC Based on MRI

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05160714

Studienbeginn:
Januar 2022

Letztes Update:
01.02.2022

Wirkstoff:
-

Indikation (Clinical Trials):
Head and Neck Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
University Hospital Tuebingen

Collaborator:
-

Kontakt

Simon Böke, MD
Kontakt:
Phone: 49 (0) 7071 29
Phone (ext.): 82165
E-Mail: ro-info@med.uni-tuebingen.de» Kontaktdaten anzeigen

Daniel Zips, MD, Prof.
Kontakt:
Phone: 49 (0) 7071 29
Phone (ext.): 82165
E-Mail: ro-info@med.uni-tuebingen.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

UKT Radiooncology
72076 Tübingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Simon Böke, MD
Phone: +49 7071 29
Phone (ext.): 82165
E-Mail: roinfo@med.uni-tuebingen.de» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

This single-center, non-randomized interventional dose-finding phase I trial evaluates the

maximal tolerated boost dose with respect to dose limiting toxicities in patients with

locally advanced head and neck squamous cell carcinoma (UICC stage III/IVB) with an

indication for a primary radiochemotherapy. The primary aim of the trial is to define the

maximal tolerated dose in an ADC-based subvolume using an adaptive SBRT-boost areal.

Dose-escalated SBRT boost to ADC-high risk volume will be delivered once a week and is

defined according to the the actual imaging immediately performed prior to delivery

(real-time adaptive) i.e. it can vary from one week to another and it might also be reduced

throughout the course of treatment (response adaptive). In case of complete disappearance of

high-risk subvolumes sufficient large enough to boost (<5ml), no further ADC boost but only

the floor-boost dose is given. The dose escalation of the ADC-high risk volume boost is

graduated in four dose levels of 5x5 Gy, 5x5.5 Gy, 5x6 Gy, 5x6.5 Gy in a classical 3+3

dose-finding design where 3 patients per radiation dose level are enrolled. Primary endpoint

is the dose limiting toxicity, any acute and late non-hematologic grade 4 or 5 related to the

radiotherapy intervention, ≥ grade 3 CTC v.5. oral mucositis at 3 months after radiotherapy.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Age: older than 18 years

- WHO (ECOG) performance status 0-2

- Histological proven HNC (squamous cell carcinoma)

- HPV negative tumors or high risk HPV positive tumors

- Stage III - IVB HNC of the hypopharynx, oropharynx and oral cavity according to UICC

and AJCC guidelines

- Tumor extension and localization suitable for radiochemotherapy with curative intent

- Simultaneous standard chemotherapy with cisplatin applicable (no contra-indications)

- Dental examination and -treatment before start of therapy

- For women with childbearing potential and men in reproductive ages adequate

contraception.

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

trial

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

Exclusion Criteria:

- Refusal of the patients to take part in the trial

- Presence of distant metastases (UICC stage IVC)

- HPV positive tumors UICC Stage III with T1/2 N3, despite of smoking status

- Previous radiotherapy in the head and neck region

- Second malignancy that is likely to require treatment during the trial intervention or

follow-up period or that, in the opinion of the physician, has a considerable risk of

recurrence or metastases within the follow-up period

- Serious disease or medical condition with life expectancy of less than one year

- Participation in competing interventional trial on cancer treatment

- Patients who are not suitable for radiochemotherapy

- Pregnant or lactating women

- Patients not able to understand the character and individual consequences of the trial

- Nasopharyngeal and glottis laryngeal carcinomas

- Patients with contraindications for magnet-resonance tomography

Studien-Rationale

Primary outcome:

1. Dose limiting toxicity (DLT) (Time Frame - At 3 months after radiotherapy):
Dose limiting toxicity (DLT): any acute and late grade 4 or 5 related to the intervention, ≥ grade 3 CTC v.5. oral mucositis at 3 months after radiotherapy (persistent mucosal ulceration or inflammation in the high dose region with severe pain; interfering with oral intake; limiting self-care ADL)

Secondary outcome:

1. Regional tumor control (Time Frame - After 6 weeks, 3 months and every 3 months up to two years):
Regional tumor control will be measured by clinical H&N examinations at six weeks and then every three months up to two years. Imaging follow-up includes MRI at 6 weeks and 3 months, FDG-PET CT at 3 months and further CTs every 3 month.

2. Disease free survival (Time Frame - During treatment and after 6 weeks, 3 months and every 3 months up to two years):
Clinical H&N examinations at six weeks and then every three months up to two years, including MRI at 6 weeks and 3 months, FDG-PET CT at 3 months and further CTs every 3 month.

Geprüfte Regime

Real-time ADC-guided response adaptive Boost in HNC:
40 Gy in 20 fractions over 5 weeks (Monday to Thursday) to the adjuvant neck, simultaneous integrated boost with 56 Gy in 20 fractions in 5 weeks to the low-risk macroscopic tumor. Once weekly Dose-escalated SBRT adaptive boost to an ADC-based high risk subvolume with graduated dose levels of 5x5 Gy, 5x5.5 Gy, 5x6 Gy, 5x6.5 Gy

Quelle: ClinicalTrials.gov

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