NCT06035653

Brief Summary

The study aims to retrospectively, and anonymously analyse the data of patients treated over a period of 12 months. These are the patients whose radiotherapy plan were needed to be reviewed in the weekly on-treatment head and neck multi-professional radiotherapy meeting during the course of their radiation. Collected clinical data will be included in the retrospective analysis, comparing the clinical decision (gold standard of care), against the predictive capability of intelligence software

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 9, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2023

Completed
Last Updated

September 18, 2023

Status Verified

September 1, 2023

Enrollment Period

8 months

First QC Date

May 9, 2023

Last Update Submit

September 15, 2023

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (6)

  • Interobserver variability studies (IOV) between manually contoured CTVs and software-generated deformed CTVs

    Measured by volume differences

    1 year

  • Interobserver variability studies (IOV) between manually contoured CTVs and software-generated deformed CTVs - Sorensen-DICE Coefficient

    Measurement of ratio of overlap

    1 year

  • Interobserver variability studies (IOV) between manually contoured CTVs and software-generated deformed CTVs - Discordance Index

    Measurement of over contouring

    1 year

  • Interobserver variability studies (IOV) between manually contoured CTVs and software-generated deformed CTVs - Geographical miss index

    Measurement of under contouring

    1 year

  • Interobserver variability studies (IOV) between manually contoured CTVs and software-generated deformed CTVs - Hausdorff distance

    Measurement of distance between 2 volumes

    1 year

  • PTV margins compared against the departmental standards

    Proportion of clinical tumour volume covered by different radiotherapy set up margins 3, 4 and 5mm

    1 year

Secondary Outcomes (2)

  • Potential time saved recontouring with software and the associated cost of re-planning adaptive radiotherapy

    1 year

  • Evaluation of clinical decision on total radiotherapy re-plan

    1 year

Study Arms (2)

A

Minimum of 12 patients who required total radiotherapy replan

B

Minimum of 28 patients who were reviewed in the multi-professional meeting but did not require full replan

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Minimum of 12 patients who required total radiotherapy replan (Cohort A) Minimum of 28 patients who were reviewed in the multi-professional meeting but did not require full replan (Cohort B) Minimum of 40 patients in total (Cohorts A\&B).

You may qualify if:

  • i. Head and neck cancer patients who require new mask for radiotherapy replanning will be included (Cohort A). These patients typically are ones with rapid shrinkage of the nodal disease, or whose weight change is notable (5 - 10% of baseline) in the first 2 weeks of radiotherapy ii. Patients on close observation of the head and neck multi-professional team but whose radiotherapy did no undergo total replan treatment will be included (Cohort B)

You may not qualify if:

  • i. Patients whose primary malignancy is not of head and neck origin ii. Patients who specifically opt against their information be used anonymously iii. Head and neck cancer patients whose radiotherapy plans did not require review in the head and neck multi-professional radiotherapy meeting iv. Patients under the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East & North Hertfordshire NHS Trust

Northwood, UK, HA6 2RN, United Kingdom

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Central Study Contacts

Kevin Chiu

CONTACT

0203 826 2020k.chiu@nhs.net

Rishma Bhatti

CONTACT

0203 826 2020mvccresearch.enh-tr@nhs.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2023

First Posted

September 13, 2023

Study Start

April 3, 2023

Primary Completion

November 27, 2023

Study Completion

November 27, 2023

Last Updated

September 18, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)