Assessment of the Effect of Tumor Thickness and Site on Level IV Cervical Lymph Nodes in Squamous Cell Carcinoma of the Tongue and Floor of the Mouth: A Case Series Study

NCT06169605 | Recruiting

• 1 other identifier: Cairo uni PhD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Regarding oral cavity cancer, the high incidence of neck metastasis along with its impact on survival and prognosis are in favor of elective neck dissection. Moreover, occult metastases could develop at lower levels in the neck (levels IV-V) Regarding the tongue, the rate of skip (occult) metastasis involving unremoved level IV cervical lymph nodes in squamous cell carcinoma of the tongue ranges from 0 % - 11.4 %. However, no data is available or a correlation between the risk of level IV involvement and the affection of specific tongue subsites or a certain cutoff value of tumor thickness.

Conditions

Tongue Neoplasms

Outcome Measures

Primary Outcomes (2)

• tumor thickness in mellimeters

  histological assessment of tumor thickness of the resected tumor and assessment of level IV lymph nodes

  one week: specimens are submitted immediately after surgery

• Number of affected level IV cervical lymph nodes

  In each case the specimen will be assessed for level IV lymph nodes affection

  One week : submitted immediately after surgery

Secondary Outcomes (1)

• affected tongue site in relation to level IV cervical lymph nodes

  One week

Study Arms (1)

Patients with squamous cell carcinoma of the tongue and floor of the mouth

EXPERIMENTAL

Intervention group

Procedure: removal of primary tumor, neck dissection

Interventions

removal of primary tumor, neck dissection PROCEDURE

removal of the primary tumor with safety margins and removal of the neck lymph node levels I, II, III and IV. histological assessment of tumor thickness and whether it is associated with positive nodes in level IV or not.

Patients with squamous cell carcinoma of the tongue and floor of the mouth

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with squamous cell carcinoma of the tongue and floor of the mouth.
• Age group: from 15 to 60 years old
• No sex predilection

You may not qualify if:

• Patients with recurrent squamous cell carcinoma of the tongue and floor of the mouth.
• Irradiated patients or those taking chemotherapy.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

RECRUITING

Related Publications (6)

• Fakih AR, Rao RS, Borges AM, Patel AR. Elective versus therapeutic neck dissection in early carcinoma of the oral tongue. Am J Surg. 1989 Oct;158(4):309-13. doi: 10.1016/0002-9610(89)90122-0.

  PMID: 2802032 BACKGROUND

• Kligerman J, Lima RA, Soares JR, Prado L, Dias FL, Freitas EQ, Olivatto LO. Supraomohyoid neck dissection in the treatment of T1/T2 squamous cell carcinoma of oral cavity. Am J Surg. 1994 Nov;168(5):391-4. doi: 10.1016/s0002-9610(05)80082-0.

  PMID: 7977957 BACKGROUND

• Hutchison IL, Ridout F, Cheung SMY, Shah N, Hardee P, Surwald C, Thiruchelvam J, Cheng L, Mellor TK, Brennan PA, Baldwin AJ, Shaw RJ, Halfpenny W, Danford M, Whitley S, Smith G, Bailey MW, Woodwards B, Patel M, McManners J, Chan CH, Burns A, Praveen P, Camilleri AC, Avery C, Putnam G, Jones K, Webster K, Smith WP, Edge C, McVicar I, Grew N, Hislop S, Kalavrezos N, Martin IC, Hackshaw A. Nationwide randomised trial evaluating elective neck dissection for early stage oral cancer (SEND study) with meta-analysis and concurrent real-world cohort. Br J Cancer. 2019 Nov;121(10):827-836. doi: 10.1038/s41416-019-0587-2. Epub 2019 Oct 15.

  PMID: 31611612 BACKGROUND

• Shah JP, Candela FC, Poddar AK. The patterns of cervical lymph node metastases from squamous carcinoma of the oral cavity. Cancer. 1990 Jul 1;66(1):109-13. doi: 10.1002/1097-0142(19900701)66:13.0.co;2-a.

  PMID: 2354399 BACKGROUND

• Dias FL, Lima RA, Kligerman J, Farias TP, Soares JR, Manfro G, Sa GM. Relevance of skip metastases for squamous cell carcinoma of the oral tongue and the floor of the mouth. Otolaryngol Head Neck Surg. 2006 Mar;134(3):460-5. doi: 10.1016/j.otohns.2005.09.025.

  PMID: 16500445 BACKGROUND

• Matos LL, Manfro G, Santos RV, Stabenow E, Mello ES, Alves VA, Pinto FR, Kulcsar MA, Brandao LG, Cernea CR. Tumor thickness as a predictive factor of lymph node metastasis and disease recurrence in T1N0 and T2N0 squamous cell carcinoma of the oral tongue. Oral Surg Oral Med Oral Pathol Oral Radiol. 2014 Aug;118(2):209-17. doi: 10.1016/j.oooo.2014.03.023. Epub 2014 Apr 12.

  PMID: 24906946 BACKGROUND

MeSH Terms

Conditions

Tongue Neoplasms

Interventions

Neck Dissection

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Tongue Diseases

Intervention Hierarchy (Ancestors)

Lymph Node Excision; Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures

Study Officials

• Mohamed Shawky, MSc

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Shawky, MSc

CONTACT

+201223933897; m.shawky1993@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: December 3, 2023
• First Posted: December 13, 2023
• Study Start: April 1, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After study completion
• Access Criteria: From Corresponding author

Locations

EG (1)