NCT04967638

Brief Summary

This study aims to assess the survival rate of oral squamous cell carcinoma (OSCC) patients following immediate mandibular reconstruction with vascularized fibula flap (VFF) and to identify risk factors influencing the overall survival rate and postoperative outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 19, 2021

Completed
Last Updated

July 19, 2021

Status Verified

July 1, 2021

Enrollment Period

3 months

First QC Date

July 7, 2021

Last Update Submit

July 15, 2021

Conditions

Head and Neck Cancer

Keywords

Squamous cell carcinomaFree fibula flapPrognosisSurvivalMandibular reconstruction

Outcome Measures

Primary Outcomes (1)

  • The overall cumulative survival

    The overall cumulative survival was recorded at the fifth-year.

    5th year

Interventions

tumor resection and mandible reconstructionPROCEDURE

The patients who underwent primary ablative tumor resection with segmental mandibulectomy and immediate VFF reconstruction were retrieved from the database

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The files of patients diagnosed and treated between January 1996 to June 2019 for OSCC were retrospectively reviewed. The patients who underwent primary ablative tumor resection with segmental mandibulectomy and immediate VFF reconstruction were retrieved from the database

You may qualify if:

  • Clinical diagnosis of stage IV OSCC
  • Follow-up period more than one year.

You may not qualify if:

  • Non-neoplastic diseases
  • Two-staged reconstruction
  • Presurgical distant metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, Belgium

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsCarcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 7, 2021

First Posted

July 19, 2021

Study Start

June 1, 2020

Primary Completion

September 1, 2020

Study Completion

December 1, 2020

Last Updated

July 19, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)