Clinical trial · Interventional
Survival Benefit of Elective Neck Dissection in T1,2N0M0 Oral Squamous Cell Carcinoma
Survival Benefit of Elective Neck Dissection for Patients With T1,2N0M0 Oral Squamous Cell Carcinoma-A Prospective Multicenter Randomized Controlled Study
- 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)
Controversy over surgical treatment of clinically negative neck in early stage oral squamous cell carcinoma revolves around the uncertainty of its impact on patient prognosis. The efficacy of elective neck dissection on prognosis in T1, 2 N0M0 patients continues to be the subject of clinical debate. Currently the clinically negative patients are treated by one of the two main policies: one is elective neck dissection; the other is "watchful waiting". The objective of this multi-institutional prospective randomized controlled study is to evaluate the survival benefit of elective neck dissection on the prognosis of T1, 2 N0M0 patients with carcinoma of oral cavity. The enrolled patients with T1, 2 N0M0 oral cancer will be randomized into two groups: elective neck dissection versus watch and wait. The survival rate and the recurrence rate between two groups will be compared. The result of the study will give surgeons evidence-based instructions for the management of clinically negative neck in patients with cancer of oral cavity.
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 |
|---|---|---|---|
| Oral Squamous Cell Carcinoma | Oral Cavity Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| elective neck dissection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- elective neck dissection
- description
- patient underwent elective neck dissection as initial treatment, along with the excision of the primary tumor
- interventionNames
- Procedure: elective neck dissection
- type
- NO_INTERVENTION
- label
- wait and see
- description
- patient underwent primary tumor excision transorally as initial treatment, and without a cervical intervention
Primary outcomes (1)
- measure
- Whether elective neck dissection (END) has equal or higher survival rate to the wait and watch policy
- timeFrame
- 5 years
- description
- The 5-year's survival and the disease free survival of the two group of patients are being measured and compared with one and other, so the survival benefit of the two policy is evaluated.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age:20 to 70 years old, both male and female 2. Histologically proven T1 or T2 N0 M0 (clinical) squamous cell carcinoma of the oral tongue, buccal mucosa, gingiva, floor of mouth, and hard palate 3. The maximum diameter of the primary tumor is less than 4cm 4. Clinical nodal staging has been confirmed negative via both clinical examination and imaging (MRI or lateral and central neck ultrasound) 5. With at least 1-year's expected survival time 6. Willing to join the protocol and is able to give written informed consent Exclusion Criteria: 1. Patient with severe cardiac insufficiency, hepatic insufficiency, renal insufficiency, of systemic infection diseases 2. The patient is pregnant or lactating 3. Patients with a history of surgical treatment, radiotherapy, chemotherapy, biotherapy and targeted therapy, et al, before participating in the study 4. Patient is currently participating in another investigational drug study
References
Publications (4)
- BACKGROUNDYuen AP, Ho CM, Chow TL, Tang LC, Cheung WY, Ng RW, Wei WI, Kong CK, Book KS, Yuen WC, Lam AK, Yuen NW, Trendell-Smith NJ, Chan YW, Wong BY, Li GK, Ho AC, Ho WK, Wong SY, Yao TJ. Prospective randomized study of selective neck dissection versus observation for N0 neck of early tongue carcinoma. Head Neck. 2009 Jun;31(6):765-72. doi: 10.1002/hed.21033. PMID 19408291
- BACKGROUNDD'Cruz AK, Siddachari RC, Walvekar RR, Pantvaidya GH, Chaukar DA, Deshpande MS, Pai PS, Chaturvedi P. Elective neck dissection for the management of the N0 neck in early cancer of the oral tongue: need for a randomized controlled trial. Head Neck. 2009 May;31(5):618-24. doi: 10.1002/hed.20988. PMID 19132717
- BACKGROUNDRodrigo JP, Shah JP, Silver CE, Medina JE, Takes RP, Robbins KT, Rinaldo A, Werner JA, Ferlito A. Management of the clinically negative neck in early-stage head and neck cancers after transoral resection. Head Neck. 2011 Aug;33(8):1210-9. doi: 10.1002/hed.21505. Epub 2010 Dec 6. PMID 21755564
- DERIVEDWorthington HV, Bulsara VM, Glenny AM, Clarkson JE, Conway DI, Macluskey M. Interventions for the treatment of oral cavity and oropharyngeal cancers: surgical treatment. Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD006205. doi: 10.1002/14651858.CD006205.pub5. PMID 37650478