Primary objective: study the technical feasibility and safety to perform stereotactic radiotherapy on MR-linac for cT1-2 glottic cancer patients.Secondary objectives: monitor the patient safety, toxicity and tolerability of this…
ID
Source
Brief title
Condition
- Other condition
Synonym
Research involving
Sponsors and support
Intervention
- Other intervention
N.a.
Outcome measures
Primary outcome
<p>The percentage of fractions successfully performed on MR-Linac and the safety of the treatment looking at grade 3 late toxicity.</p>
Secondary outcome
<p>Patient safety, toxicity and tolerability of this treatment concept.</p>
Background summary
In order to decrease the number of radiotherapy fractions in cT1-2 stage glottic larynx cancer patients, a stereotactic approach on MR-Linac is proposed. This approach consists of 5 fractions (8.5 Gy/fx) instead of the conventional 25 fractions (2.4 Gy/fx).
Study objective
Primary objective: study the technical feasibility and safety to perform stereotactic radiotherapy on MR-linac for cT1-2 glottic cancer patients.
Secondary objectives: monitor the patient safety, toxicity and tolerability of this treatment concept.
Study design
Phase I feasibility study
Intervention
Patients who are able to meet the pre-treatment dose constraints will be treated with 5 fractions divided in 2-3 weeks. The primary tumor will be treated with 5x8.5 Gy (42.5 Gy). Doses on the laryngeal cartilages will be kept as low as reasonably possible. All fractions will be applied on MR-linac, which is a linear accelerator combined with an MRI (magnetic resonance imaging). The MR-linac facilitates the integration of MRI in the radiotherapy planning and treatment. This enables position and shape adaptation for the treatment plan of each fraction.
Study burden and risks
Benefits:less treatment fractions (5 vs 25) with potentially an improved oncological outcome.
Burdensome: treatment time on the MR-linac will be longer (max 60 min. vs 15 min per fraction).
Risks: higher doses on the larynx may potentially lead to a higher toxicity outcome. However, since we only include non-smoking patients that meet the pre-defined dose constraints, we expect to have reduced this risk.
M. de Ridder
Heidelberglaan 100
Utrecht 3584 CX
Netherlands
088 75 63022
m.deridder-5@umcutrecht.nl
M. de Ridder
Heidelberglaan 100
Utrecht 3584 CX
Netherlands
088 75 63022
m.deridder-5@umcutrecht.nl
Trial sites in the Netherlands
Listed location countries
Age
Inclusion criteria
Squamous cell carcinoma of the glottic larynx, cT1-2 N0M0 stage, indication for curative radiotherapie
Exclusion criteria
Concurrent chemotherapy or cetuximab, smoking at the time of treatment, patients unsuited for MRI-imaging, pre-treatment dosimetric constraints are not met, malignant tumor(s) at another site, previous malignancies in the HN region treated with surgery, chemotherapy or radiotherapy, age < 18 years, participation in another interventional study, mental or physical impairment causing the participant to be unable to fill out questionnaires
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL88385.041.25 |
| Research portal | NL-009228 |