MedDataX Logo

Risk for Subsequent Osteoradionecrosis in A Transferred Fibula Flap in Head and Neck Cancer Patients Undergoing Segmental Mandibulectomy: a Cohort Study

NCT ID: NCT06428994

Last Updated: 2024-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

580 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-01

Study Completion Date

2022-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A retrospective analysis of 329 patients at one single institution between January 2014 and December 2019 who underwent free fibula flap reconstruction was conducted. A variety of clinicopathological postoperative parameters were identified and assessed.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Upfront Neck Dissection Before Radiotherapy in Stage N3 Nasopharyngeal Carcinoma: A Retrospective Study

NCT07180173

Oncology Radiology
ACTIVE_NOT_RECRUITING

Total Body Composition in Detection of Nutrition Depletion in Head and Neck Patients

NCT02854735

Head and Neck Neoplasms Dual-Energy X-Ray Absorptiometry Malnutrition
UNKNOWN

Radiation Field, Dose and Fractionation Related to Mandibular Complications

NCT05412849

Head and Neck Neoplasms Osteoradionecrosis Radiotherapy; Complications
RECRUITING

Hippocampal-Sparing Prophylactic Cranial Irradiation in Pathologically Nodal Positive Non-Small-Cell Lung Cancer

NCT02448992

Non-Small-Cell Lung Cancer (NSCLC) Brain Metastasis
RECRUITING PHASE2/PHASE3

Postoperative Radiotherapy of Non-small Cell Lung Cancer: Accelerated vs. Conventional Fractionation

NCT02189967

Non-Small Cell Lung Cancer
COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study was conducted as a monocentric, retrospective study. Patients who underwent a mandibular reconstruction with a free fibula flap due to head and neck cancer through January 2014 to December 2019 at one single institution in Taiwan were identified. All charts including surgical records, progress notes, nursing records, clinic notes, imaging study after surgery were reviewed. Data extraction was performed for the following variables: Patient demographics, primary diagnosis, cancer location and staging, treatment prior to index surgery, postoperative hemoglobin and albumin, operating time, flap type, mandibular defect length, type of the defect according to Jewer's classification, ischemia time, number of fibula segments, plate type, re-exploration, time of hospitalization, postoperative radiotherapy and/or chemotherapy, ORN cases, identification time of ORN and management for ORN. The patients were then organized into two groups: ORN and non-ORN. This research was approved by the Institutional Review Board of our hospital (No. 201800172B0), which was available until 2022/02/28. The investigators completed data analysis before 2022/02/28 and then initiated manuscript preparing.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Head and Neck Cancer Fibula Flap Osteoradionecrosis Mandibulectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ORN

ORN in this study is defined as exposed irradiated bone tissue that fails to heal over a period of three months without residual or recurrent tumors.

Radiotherapy

Intervention Type RADIATION

Post-operative radiotherapy for head and neck cancer

non-ORN

Patients without ORN.

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Radiotherapy

Post-operative radiotherapy for head and neck cancer

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients who underwent a mandibular reconstruction with a free fibula flap due to head and neck cancer through January 2014 to December 2019.

Exclusion Criteria

* Cases with incomplete medical records.
* Patients who did not attend at least 6 months of follow ups.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Angela Chien-Yu Chen

Taoyuan District, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

No. 201800172B0

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Evaluation of Spinal Metastatic Tumour for Aggressive Spinal Sugery by Dual Energy CT
NCT03631095 COMPLETED
Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers
NCT06798922 RECRUITING PHASE3
De-Intensification of Postoperative Radiotherapy in Patients with Squamous Cell Carcinoma of the Head and Neck
NCT06030440 RECRUITING PHASE2/PHASE3
Prospective Trial of Serial CT Imaging for Evaluation of Dosimetric/Volumetric Changes During IMRT for Head/Neck Cancer
NCT02003482 COMPLETED
The Total Neoadjuvant Therapy for Soft Tissue Sarcoma of the Extremities
NCT06593899 RECRUITING PHASE2
Monitoring Chemotherapy Response of Soft Tissue Sarcomas and Osteosarcomas Using Diffuse Optical Spectroscopic Imaging
NCT01263405 COMPLETED
Effect of High Doses of Radiation on Bone Structure and Metabolism
NCT02323295 COMPLETED NA
Comparative Study of Chemoradiation and Sequential Chemoradiation About Lung Adenocarcinoma Patients With Postoperative in pN2
NCT02132143 UNKNOWN NA
Radiation Therapy Following Surgery in Treating Patients With Recurrent or Second Primary Cancer of the Head and Neck Following Previous Radiation Therapy
NCT00004226 UNKNOWN PHASE1/PHASE2
Retrospective Study on the Prediction of Radiation-induced Brain Injury in Patients With Nasopharyngeal Carcinoma
NCT06244394 COMPLETED
Monitoring Skeletal Muscle Mass Using CBCT in Patients With H&N Cancer Undergoing Chemoradiotherapy
NCT05126095 UNKNOWN
The Character of Perfusion Parameters Derived From MDCT Between Adenocarcinoma and Squamous Cell Carcinoma of Lung in the Treatment Course of Radiation Therapy
NCT00751543 UNKNOWN NA
Osteoradionecrosis Rate in Patients Undergoing Radiotherapy for Head and Neck Cancer Treatment.
NCT04009161 UNKNOWN
Preoperative Radiotherapy for Sarcomas of the Extremities With Intensity-Modulation, Image-Guidance and Small Safety-margins
NCT01552239 UNKNOWN PHASE2
Deep Learning-based sbORN Diagnostic Model
NCT06463392 RECRUITING
Telemonitoring After Surgery to Preserve Limb Function in Optimizing Mobility in Cancer Survivors With Skeletal Metastases
NCT02715856 TERMINATED NA
Post Operative RT for Limited Spine Metastases
NCT05495399 RECRUITING NA
Radio/Pathological Evaluation of Tongue Cancer Infiltration
NCT04821128 UNKNOWN
Efficacy and Toxicity of SCART
NCT06341257 WITHDRAWN NA
Individualized Elective Neck Irradiation in NPC Patients
NCT06241612 RECRUITING PHASE3
Local Treatment for Bone Metastases
NCT05665439 NOT_YET_RECRUITING NA
A Prospective Longitudinal Cohort Study Looking at the Difference in Carotid Intima-medial Thickness Between Irradiated and Unirradiated Carotid Arteries in Patients With Head and Neck Cancer
NCT02069964 UNKNOWN
Risk Factors of Radiation Pneumonitis
NCT00155909 UNKNOWN
Post-operative Radiotherapy in Poor Responders Ewing's Sarcoma Patients
NCT01734863 WITHDRAWN PHASE3
Optical Coherence Tomography in Patients With Radiotherapy for Head and Neck Cancer
NCT04610645 COMPLETED