Adaptive Radiotherapy in Head and Neck Tumor Patients | NCT06216171

Studies
Adaptive Radiotherapy in Head and Neck Tumor Patients

NCT06216171

Sponsor

University Hospital, Essen

Status

Recruiting

Last Update Posted

Sep 27, 2024Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Head and Neck Neoplasms
Head and Neck Cancer
Adaptive Radiotherapy
Optimization

Interventions

Adaptive Radiotherapy
image guided radiotherapy without online adaptation

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 25, 2024Actual

Primary Completion Date

Apr 30, 2025Estimated

Completion Date

Jan 30, 2028Estimated

First Submitted Date

Dec 30, 2023

First Submission Date that Met QC Criteria

Jan 19, 2024

First Posted Date

Jan 22, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2024

Last Update Posted Date

Sep 27, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maja Guberina, PD Dr. med. (MD) M. Guberina (senior consultant, specialist), University Hospital, EssenPrincipal Investigator

Lead Sponsor

University Hospital, EssenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Most newly diagnosed oropharyngeal and hypopharyngeal cancers are treated with radiochemotherapy with curative intent. If the field-set UP margins are broad, the consequence may be that quality of life is impaired. The study group of Nutting et al. (2023) investigated this year whether dysphagia-optimized intensity-modulated radiotherapy can reduce the radiation dose to structures associated with dysphagia and aspiration and improve swallowing function compared to standard IMRT (Nutting C, Finneran L, Roe J, Petkar I, Rooney K, Hall E; DARS Triallist Group. Dysphagia-optimized intensity-modulated radiotherapy versus standard radiotherapy in patients with pharyngeal cancer - Authors' reply. Lancet Oncol. 2023 Oct;24(10):e398. doi: 10.1016/S1470-2045(23)00457-6. PMID: 37797636.) The study group concluded that the results suggest that dysphagia-optimized IMRT improves patient-reported swallowing function compared to standard IMRT. DO-IMRT should be considered the new standard of care for patients receiving radiotherapy for pharyngeal cancer, and ART could further improve outcomes.

Detailed Description

Thus, in this trial we analyze ART in head and neck cancer in a prospective randomized trial.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adaptive Radiotherapy	Experimental	Adaptive Radiotherapy, online onboard adaptation of the dosis to actual anatomy of the day by a specialist of radiation oncology and a medical physicist	Radiation: Adaptive Radiotherapy
Standard conventional Treatment Arm, IGRT	Active Comparator	Standard treatment option, image guided radiotherapy without online adaptation	Radiation: image guided radiotherapy without online adaptation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adaptive Radiotherapy	Radiation	Adaptive Radiotherapy	Adaptive Radiotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
EORTC CTC AE Score	quality of life, Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Published: November 27, 2017	2 months - 5 years
Dysphagia score	Dysphagia score	2 months - 5 years

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival	Overall Survival	2-5 years
Progression Free Survival	Progression Free Survival	2-5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ECOG 0/1 No prior cancer treatment

Exclusion Criteria:

ECOG 2-4 Prior cancer treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maja Guberina	Recruiting	Essen		45147	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006258	Head and Neck Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D061089	Radiotherapy, Image-Guided

Ancestor Terms

ID	Term
D011878	Radiotherapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided