Clinical trial · Interventional
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
NCT06169605CI-TRIAL-00077558unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tongue Neoplasms | Tongue Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| removal of primary tumor, neck dissection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with squamous cell carcinoma of the tongue and floor of the mouth
- description
- Intervention group
- interventionNames
- Procedure: removal of primary tumor, neck dissection
Primary outcomes (2)
- measure
- tumor thickness in mellimeters
- timeFrame
- one week: specimens are submitted immediately after surgery
- description
- histological assessment of tumor thickness of the resected tumor and assessment of level IV lymph nodes
- measure
- Number of affected level IV cervical lymph nodes
- timeFrame
- One week : submitted immediately after surgery
- description
- In each case the specimen will be assessed for level IV lymph nodes affection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with squamous cell carcinoma of the tongue and floor of the mouth. * Age group: from 15 to 60 years old * No sex predilection Exclusion Criteria: * Patients with recurrent squamous cell carcinoma of the tongue and floor of the mouth. * Irradiated patients or those taking chemotherapy.
References
Publications (6)
- BACKGROUNDFakih 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
- BACKGROUNDKligerman 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
- BACKGROUNDHutchison 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
- BACKGROUNDShah 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
- BACKGROUNDDias 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
- BACKGROUNDMatos 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.