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Survival Benefit of Elective Neck Dissection for Patients With T1,2N0M0 Oral Squamous Cell Carcinoma—A Prospective Multicenter Randomized Controlled Study


N/A
20 Years
70 Years
Open (Enrolling)
Both
Oral Squamous Cell Carcinoma

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Trial Information

Survival Benefit of Elective Neck Dissection for Patients With T1,2N0M0 Oral Squamous Cell Carcinoma—A Prospective Multicenter Randomized Controlled Study


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Whether elective neck dissection (END) has equal or higher survival rate to the wait and watch policy

Outcome 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.

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Guiqing Liao, MD, DDS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sun Yat-sen University

Authority:

China: Ethics Committee

Study ID:

2010018

NCT ID:

NCT01334320

Start Date:

April 2011

Completion Date:

December 2021

Related Keywords:

  • Oral Squamous Cell Carcinoma
  • oral squamous cell carcinoma
  • elective neck dissection
  • "watchful waiting"
  • survival benefit
  • recurrence rate
  • Carcinoma
  • Carcinoma, Squamous Cell

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