Survival Benefit of Elective Neck Dissection in T1 2N0M0 Oral Squamous Cell Carcinoma

  • STATUS
    Recruiting
  • End date
    Dec 21, 2021
  • participants needed
    448
  • sponsor
    Sun Yat-sen University
Updated on 21 January 2021

Summary

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.

Description

There are controversies on the benefits of elective neck dissection (END) for clinically negative neck in early stage oral squamous cell carcinoma. The aim of this study is to determine the need for a randomized controlled trial in order to evaluate the survival benefit of elective neck dissection on the prognosis of T1, 2 N0M0 patients with carcinoma of oral cavity. We initiate this multi-institutional study, expecting 448 primary oral cancer patients to be enrolled. And we are going to randomly divide these patients into two groups: END and "watch and wait". The END group will undergo one stage surgery of END and primary tumor excision, and the "watch and wait"group will be treated with primary tumor excision transorally as initial treatment, with rigorous postoperation consultation. All patients will be followed up with at least 5 years after initial treatment, and the survival rate and the recurrence rate between groups will be compared.

Details
Condition Oral Squamous Cell Carcinoma
Treatment elective neck dissection
Clinical Study IdentifierNCT01334320
SponsorSun Yat-sen University
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 20 yrs and 70 yrs?
Gender: Male or Female
Do you have Oral Squamous Cell Carcinoma?
Do you have any of these conditions: Do you have Oral Squamous Cell Carcinoma??
Age:20 to 70 years old, both male and female
Histologically proven T1 or T2 N0 M0 (clinical) squamous cell carcinoma of the oral tongue, buccal mucosa, gingiva, floor of mouth, and hard palate
The maximum diameter of the primary tumor is less than 4cm
Clinical nodal staging has been confirmed negative via both clinical examination and imaging (MRI or lateral and central neck ultrasound)
With at least 1-year's expected survival time
Willing to join the protocol and is able to give written informed consent

Exclusion Criteria

Patient with severe cardiac insufficiency, hepatic insufficiency, renal insufficiency, of systemic infection diseases
The patient is pregnant or lactating
Patients with a history of surgical treatment, radiotherapy, chemotherapy, biotherapy and targeted therapy, et al, before participating in the study
Patient is currently participating in another investigational drug study
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