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

Primary Purpose

Oral Squamous Cell Carcinoma

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

elective neck dissection

About this trial

This is an interventional treatment trial for Oral Squamous Cell Carcinoma focused on measuring oral squamous cell carcinoma, elective neck dissection, "watchful waiting", survival benefit, recurrence rate

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

Hospital of Stomatology, Sun Yat-sen UniversityRecruiting
Cancer Center, Sun Yat-Sen University Cancer Center
The First Affiliated Hospital, Sun Yat-Sen University
Sun Yat-sen Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

elective neck dissection

wait and see

Arm Description

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

patient underwent primary tumor excision transorally as initial treatment, and without a cervical intervention

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

quality of life

The quality of life of patients after surgery is measured by UW-QOL.

Full Information

NCT ID

NCT01334320

First Posted

April 6, 2011

Last Updated

April 9, 2015

Sponsor

Sun Yat-sen University

Collaborators

First Affiliated Hospital, Sun Yat-Sen University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

1. Study Identification

Unique Protocol Identification Number

NCT01334320

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Unknown status

Study Start Date

April 2011 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

Collaborators

First Affiliated Hospital, Sun Yat-Sen University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oral Squamous Cell Carcinoma

Keywords

oral squamous cell carcinoma, elective neck dissection, "watchful waiting", survival benefit, recurrence rate

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

448 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

elective neck dissection

Arm Type

Experimental

Arm Description

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

Arm Title

wait and see

Arm Type

No Intervention

Arm Description

patient underwent primary tumor excision transorally as initial treatment, and without a cervical intervention

Intervention Type

Procedure

Intervention Name(s)

elective neck dissection

Other Intervention Name(s)

superior omohyoid neck dissection, SOHND

Intervention Description

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

Primary Outcome Measure Information:

Title

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

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.

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Does END have the equal or lower recurrence rate to the wait and watch policy

Description

The recurrence includes recurrence of the primary tumor and the neck, and it's measured by clinical examination, MRI examination and ultrasonic inspection.

Time Frame

5 years

Title

quality of life

Description

The quality of life of patients after surgery is measured by UW-QOL.

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Guiqing Liao, MD, DDS

Phone

86-20-83862531

drliaoguiqing@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guiqing Liao, MD, DDS

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital of Stomatology, Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510055

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guiqing Liao, MD,DDS

Phone

86-20-83862531

drliaoguiqing@hotmail.com

First Name & Middle Initial & Last Name & Degree

Guiqing Liao, MD,DDS

First Name & Middle Initial & Last Name & Degree

Yuantao Hao, PhD

First Name & Middle Initial & Last Name & Degree

Yuxiong Su, MD,DDS

Facility Name

Cancer Center, Sun Yat-Sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhuming Guo, MD

Phone

86-20-33181550

guozhm@mail.sysu.edu.cn

First Name & Middle Initial & Last Name & Degree

Zhuming Guo, MD

Facility Name

The First Affiliated Hospital, Sun Yat-Sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510080

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chongjin Feng, PhD

Phone

86-20-87332200

Ext

8414

drfcj@yahoo.com.cn

First Name & Middle Initial & Last Name & Degree

Chongjin Feng, MD,DDS

Facility Name

Sun Yat-sen Memorial Hospital

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510120

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jinsong Li, PhD

Phone

86-20-81332429

lijinsong1967@163.com

First Name & Middle Initial & Last Name & Degree

Jinsong Li, MD,DDS

12. IPD Sharing Statement

Citations:

PubMed Identifier

19408291

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.

Results Reference

background

PubMed Identifier

19132717

Citation

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.

Results Reference

background

PubMed Identifier

21755564

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.

Results Reference

background

Links:

URL

http://www.ncbi.nlm.nih.gov/pubmed/?term=Management+of+the+clinically+negative+neck+in+early-stage+head+and+neck+cancers+after+transoral+resection

Description

citation 3

URL

http://www.ncbi.nlm.nih.gov/pubmed/?term=Elective+neck+dissection+for+the+management+of+the+N0+neck+in+early+cancer+of+the+oral+tongue%3A+need+for+a+randomized+controlled+trial

Description

citation 2

URL

http://www.ncbi.nlm.nih.gov/pubmed/?term=Prospective+randomized+study+of+selective+neck+dissection+versus+observation+for+N0+neck+of+early+tongue+carcinoma.

Description

citation 1

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

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