Registry to Collect Data on Patients Undergoing Segmental Mandibular Defect Reconstruction Following Oral Squamous Cell Carcinoma Resection

Mandibular Reconstruction Clinical Trial

Official title:

International, Multicenter, Prospective Registry to Collect Data on Patients Undergoing Segmental Mandibular Defect Reconstruction (SMDR) Following Oral Squamous Cell Carcinoma (OSSC) Resection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04098146
• Other study ID #: SMDR Registry
• Status: Recruiting
• Start date: September 12, 2022
• Est. completion date: December 31, 2028

Study information

• Verified date: December 2023
• Source: AO Innovation Translation Center
• Contact: Felix Thomas, PhD
• Phone: + 41 79 671 47 98
• Email: felix.thomas[@]aofoundation.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Prospective will be collected in a minimum of 300 patients presenting with an acquired segmental mandibular defect ≥ 4 cm secondary to OSSC removal and who require mandibular reconstruction.

Description:

Prospective data will be collected in a minimum of 300 patients presenting with an acquired segmental mandibular defect ≥ 4 cm secondary to OSSC removal and who require mandibular reconstruction.

The follow up (FU) will consist of standard of care (routine) procedures and data collection will be done at 3, 6, 12, 18 and up to 24 months after resection and/or reconstruction. The maximum FU for each patient within the registry will be 2 years after mandibular resection.

Data collection will include confounding baseline data, tumor characteristics, neurological function, patient reported outcomes, quality of life as well as anticipated procedure-related adverse events (AEs). Available images will be collected and evaluated centrally to determine the location, positioning, osseointegration, bone quantity and quality of the transplants.

Depending on the volume and quality of the collected data, different statistical analyses will be performed. Exploratory analyses will be conducted to find relationships between the different treatment modalities and their outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2028
• Est. primary completion date: January 31, 2027
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years and older

• Initial pathologically confirmed diagnosis of primary oral squamous cell carcinoma located in mucosa and/or mandible

• Undergoing primary curative treatment with segmental resection of the mandible =4 cm

• Intention to undergo mandibular reconstruction with autologous bone using a primary (one stage) or secondary (two stage) approach

• Informed consent obtained, ie:

• Ability to understand the content of the patient information/ICF

• Willingness and ability to participate in the clinical investigation according to the registry plan (RP)

• Signed and dated IRB/EC approved informed consent (ICF) OR

• Written consent provided according to the IRB/EC defined and approved procedures for patients who are not able to provide to provide independent written informed consent

Exclusion Criteria:

• Tumors affecting the condyle

• Distant OSCC metastasis

• Any other active concomitant malignancy within the last 5 years

• Patients who require neoadjuvant therapy

• Patients under palliative care

• Previous extensive mandibular surgeries (including reconstructions)

Intraoperative exclusion criteria:

• Nonsegmental mandibular defect (eg. box resection/partial resection)

• Segmental mandibular defect of less than 4 cm

• Mandibular defects extending beyond the sigmoid notch into the condyles

Additional exclusion criterion:

• No osseous reconstruction with autologous bone performed within 18 months from resection

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Mandibular Reconstruction
• Squamous Cell Carcinoma of Head and Neck

Intervention

Procedure:
• Surgical Resection and Reconstruction
One stage reconstruction: Osseous reconstruction is performed in the same surgery of the tumor/mandibular resection. It is also known as immediate or primary reconstruction. Second stage reconstruction: Osseous reconstruction is performed after the tumor/mandibular resection surgery as an independent surgery. After the mandibular resection a temporary alloplastic bridging might be put in place. It is also known as delayed or secondary reconstruction.

Locations

Country	Name	City	State
Germany	University Hospital RWTH Aachen	Aachen
Germany	University Hospital Charité	Berlin
Germany	Hannover Medical School	Hannover
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	University Hospital Leipzig	Leipzig
Germany	Klinikum der LMU München	Munich
Germany	Universitätsklinikum Tübingen	Tübingen	Baden-Württemberg
Netherlands	Erasmus University Medical Centre	Rotterdam
Spain	12 de Octubre	Madrid
Sweden	Uppsala University Hospital	Uppsala
Switzerland	University Hospital Basel	Basel
United States	John Peter Smith Health Network	Fort Worth	Texas
United States	University of Florida College of Medicine	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AO Innovation Translation Center

Countries where clinical trial is conducted

United States,  Germany,  Netherlands,  Spain,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographics	Demographics (year of birth, height in cm and weight in kilogram, race)	Baseline until resection surgery approximately 4 weeks
Primary	Comorbidities	Comorbidities assessed by Charlson Comorbidity Index (this score assesses the comorbidity level by considering both the number and severity of predefined comorbidity conditions. It provides a weighted score of a patient's comorbidities which can be used to predict mortality rates	Baseline until resection surgery approximately 4 weeks
Primary	Nicotine consumption	Current and previous nicotine use will be collected: Number of years; Time (years) since stopped using (if applicable); Amount of cigarettes/day	Baseline until resection surgery approximately 4 weeks
Primary	Patient reported outcome: Oral Health Impact Profile (OHIP)	Change in the OHIP over the follow-up period.; The Oral Health Impact Profile is providing a comprehensive measure of self-reported dysfunction, discomfort and disability attributed to oral conditions. The OHIP is concerned with impairment and three functional status dimensions (social, psychological, and physical). Respondents are asked to indicate on a five-point Likert scale how frequently they experienced each problem. Response categories for the five-point scale are: "Very often", "Fairly often", "Occasionally", "Hardly ever" and "Never". The OHIP consists of 14 questions in which higher scores indicate worse outcomes.	Baseline/ 3months/ 6 months/ 12 months/ 18 months/ 24 months
Primary	Difference of tumor locations of the oral squamous cell cancer	Oral squamous cell carcinoma locations acoording to follwoing regions: Anterior compartment which includes lower lip, buccal mucosa, anterior vestibule, anterior ridge and anterior floor mouth; Lateral compartment which includes posterior vestibule, posterior alveolar ridge, posterior (lateral) floor of mouth; Retromolar compartment which includes alveolar ridge posterior to last molar, region of wisdom teeth, retromolar triangle ie buccal cheek, soft palate (arch), tonsillar regions; Tongue which includes ventral tongue (undersurface of tongue), lateral rim of tongue, base of tongue	Baseline until resection surgery ( approximately 4 weeks)
Primary	Difference of tumor staging according to the TNM system	Oral squamous cell carcinoma staging according to TNM (Tumor, Node, Metastasis) system.; In the TNM system the "T" refers to the size and extent of the main tumor likert from T0 to T4 whereas T0 is the smallest and T4 the biggest size.; The main tumor is usually called the primary tumor. The "N" refers to the number of nearby lymph nodes that have cancer likert for N0 to N3 whereas N0 is the single nearby lymphnode and N3 multiple lymphnodes. The "M" refers to whether the cancer has metastasized likert from M0 to M1 whereas M0 is no distant metastasis and M1 is distant metastasis.	Baseline until resection surgery ( approximately 4 weeks)
Primary	Difference of surgical duration and hospital stay if resection and reconstruction was performed in one or two stages	Duration of surgery (skin to skin) in minutes; Length of hospital stay in days; Date of osseous reconstruction (if different from resection surgery) in days	Day of resection surgery until day of reconstruction surgery up to 18 months
Primary	Difference of surgical procedures of osseous reconstruction	Numers of Bone and soft tissue flaps to reconstruct the mandible: ie number of pieces in which the donor bone(s) is cut to shape the reconstructed mandible; Type of bone donor/ bone transfer site(s): Vascularized bone flap(s) or composite flaps (ie bone and adjacent soft tissue harvested within the same flap) and type(s)	Day of resection surgery until day of reconstruction surgery up to 18 months
Primary	Different surgical parameters of tumor and segmental mandibular resection if VSP planning was used	Use of virtual surgical planning (VSP) for resection: Yes/No.; Only virtual planning and simulation of resection (no 3D printing):Yes/No.; 3D-printed biomodels: Yes/No	Day of resection surgery until day of reconstruction surgery up to 18 months