NCT06335342

Brief Summary

The aim of this study is the evaluation of clinical and dosimetric aspects, tolerance, and effectiveness of radiotherapy treatments in the head and neck region. Eligible patients undergoing radiotherapy for primary or secondary neoplasms localized in the head and neck anatomical region.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
4,050

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

February 22, 2018

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 28, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

August 5, 2024

Status Verified

March 1, 2024

Enrollment Period

6.9 years

First QC Date

March 22, 2024

Last Update Submit

August 2, 2024

Conditions

Head and Neck Neoplasms

Outcome Measures

Primary Outcomes (2)

  • Overall Survival

    Number of patients death

    5 years

  • Disease free survival

    Number of oncological event (local recurrence, distant metastasis, other primary tumor)

    5 years

Study Arms (1)

Radiotherapy to head and neck region

Patients treated at European Institute of Oncology with radiotherapy to head and neck region

Eligibility Criteria

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

Patients treated at European Institute of Oncology with radiotherapy for curative, palliative, neo-adjuvant, and adjuvant purposes in the head and neck region

You may qualify if:

  • Patients treated with radiotherapy for curative, palliative, neo-adjuvant, and adjuvant purposes in the head and neck region include those with:
  • Primary bone tumors,
  • Primary soft tissue tumors,
  • Primary tumors of the cardio-circulatory system,
  • Primary tumors of the lymphatic system,
  • Primary tumors of the nervous system and skin,
  • Secondary metastases from various origins localized in that district.
  • Signed informed consent

You may not qualify if:

  • Radiotherapy in districts other than the head and neck region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European Institute of Oncology

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Barbara Alicja Jereczek

    European Institute of Oncology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Alicja Jereczek

CONTACT

+39 02 57489326barbara.jereczek@ieo.it

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2024

First Posted

March 28, 2024

Study Start

February 22, 2018

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

August 5, 2024

Record last verified: 2024-03

Locations

IT(1)