No registrations found.
ID
Source
Brief title
Health condition
Head and Neck Squamous Cell Carcinoma (HNSCC)
Oropharyngeal cancer
Cancer of the oral cavity
Hypopharyngeal cancer
Laryngeal cancer
Hoofd-hals kanker
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the predictive value of DW-MRI after the start of radiotherapy based on a single scan during treatment.
Secondary outcome
- ADC level and tumor volume pretreatment
- Change ADC level and gross tumor volume during therapy
- The optimal time point for MRI scanning during treatment in order to predict treatment outcome
Background summary
-
Study objective
The change in 'apparent diffusion coefficient' (ADC), obtained using diffusion weighted MRI, from pre-treatment to intra-treatment is lower in HNSCC patients with a poor response to (chemo)radiotherapy than in HNSCC patients with a good response to (chemo)radiotherapy.
Study design
Four additional MRI scans will be made in week 2, 3, 4 and 5 of the radiotherapy treatment. After finishing treatment study participants will receive 2 years of follow up as per standard post-treatment HNSCC protocol.
Intervention
Patients meeting the inclusion criteria will be recruited from the department of head and neck surgical oncology. Pretreatment imaging consist of standard head and neck MRI sequences and added diffusion weighted sequence. Subsequently all patients will receive radiotherapy with or without concomitant chemotherapy following standard procedure. During the radiotherapy course additional MRI imaging including diffusion weighted sequences will be acquired in the study group. The scans will be planned for week 2, 3, 4 and 5 of the radiotherapy course.
Boris Peltenburg
Utrecht 3508 GA
The Netherlands
+31 (0)88 75 71049
b.peltenburg-2@umcutrecht.nl
Boris Peltenburg
Utrecht 3508 GA
The Netherlands
+31 (0)88 75 71049
b.peltenburg-2@umcutrecht.nl
Inclusion criteria
- Squamous cell carcinoma
- T2, T3 or T4 Oral cavity or pharynx
- T3 or T4 larynx
- Technically resectable
- Scheduled for primary (chemo)radiation with curative intent
- ‘Informed consent’ signed by patient
Exclusion criteria
- Age < 18 years
- Pregnancy
- Patients unsuited for MRI examination as defined in the protocols of the Radiology department.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5955 |
| NTR-old | NTR6136 |
| CCMO | NL57164.041.16 |
| OMON | NL-OMON56355 |