Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-01-27 @ 2:19 AM
Study NCT ID:
NCT05423704
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-06-21
First Post:
2022-06-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Patient Selection and Treatment of Head-neck Cancer With Proton Therapy in Denmark
Sponsor:
Danish Head and Neck Cancer Group
Organization:
Study Overview
Official Title:
DAHANCA Proton Feasibility Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A study to investigate feasibility of local selection of patients with squamous cell carcinoma of the pharynx or larynx using anticipated benefit of proton radiotherapy in reducing the risk of late dysphagia or xerostomia.
Detailed Description:
In preparation for a randomised study in Denmark (DAHANCA 35) the feasibility of selecting newly diagnosed patients with squamous cell carcinoma of the pharynx or larynx for proton therapy at the local treatment centers is investigated. A proton and a photon doseplan is prepared for patients planned for primary radiotherapy . If proton radiotherapy reduces the anticipated absolute risk of dysphagia \>= grade 2 (DAHANCA scale and/or xerostomia \>= grade 2 (EORTC Head-Neck 35) with a clinical relevant value the patient is offered proton therapy at the Danish Center for Particle Therapy. The anticipated risk of xerostomia and dysphagia is estimated using Normal-Tissue Complication Models (NTCP).
At least five patients from each of the six Danish centers are required in this feasibility study.
At least five patients from each of the six Danish centers are required in this feasibility study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: