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

Oral Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01334320
• Other study ID #: 2010018
• Status: Recruiting
• Phase: N/A
• First received: April 6, 2011
• Last updated: April 9, 2015
• Start date: April 2011
• Est. completion date: December 2021

Study information

• Verified date: April 2015
• Source: Sun Yat-sen University
• Contact: Guiqing Liao, MD, DDS
• Phone: 86-20-83862531
• Email: drliaoguiqing[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 448
• Est. completion date: December 2021
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Oral Squamous Cell Carcinoma

Intervention

Procedure:
• elective neck dissection
patient underwent elective neck dissection as initial treatment, along with the excision of the primary tumor

Locations

Country	Name	City	State
China	Cancer Center, Sun Yat-Sen University Cancer Center	Guangzhou	Guangdong
China	Hospital of Stomatology, Sun Yat-sen University	Guangzhou	Guangdong
China	Sun Yat-sen Memorial Hospital	Guangzhou	Guangdong
China	The First Affiliated Hospital, Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Sun Yat-sen University	First Affiliated Hospital, Sun Yat-Sen University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

References & Publications (3)

D'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. — View Citation

Rodrigo 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. Review. — View Citation

Yuen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whether elective neck dissection (END) has equal or higher survival rate to the wait and watch policy	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.	5 years	Yes
Secondary	Does END have the equal or lower recurrence rate to the wait and watch policy	The recurrence includes recurrence of the primary tumor and the neck, and it's measured by clinical examination, MRI examination and ultrasonic inspection.	5 years	Yes
Secondary	quality of life	The quality of life of patients after surgery is measured by UW-QOL.	5 years	Yes

External Links

•   citation 1
•   citation 2
•   citation 3