NCT01334320

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
448

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 13, 2011

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

April 10, 2015

Status Verified

April 1, 2015

Enrollment Period

4.7 years

First QC Date

April 6, 2011

Last Update Submit

April 9, 2015

Conditions

Oral Squamous Cell Carcinoma

Keywords

oral squamous cell carcinomaelective neck dissection"watchful waiting"survival benefitrecurrence rate

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

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

    5 years

  • quality of life

    5 years

Study Arms (2)

elective neck dissection

EXPERIMENTAL

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

Procedure: elective neck dissection

wait and see

NO INTERVENTION

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

Interventions

elective neck dissectionPROCEDURE

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

Also known as: superior omohyoid neck dissection, SOHND
elective neck dissection

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital of Stomatology, Sun Yat-sen University

Guangzhou, Guangdong, 510055, China

RECRUITING

Cancer Center, Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

NOT YET RECRUITING

The First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

NOT YET RECRUITING

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, 510120, China

NOT YET RECRUITING

Related Publications (4)

  • 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.

    PMID: 19408291BACKGROUND

  • 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.

    PMID: 19132717BACKGROUND

  • 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.

    PMID: 21755564BACKGROUND

  • Worthington 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: 37650478DERIVED

Related Links

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Study Officials

  • Guiqing Liao, MD, DDS

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guiqing Liao, MD, DDS

CONTACT

86-20-83862531drliaoguiqing@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Guanghua School of Stomatology, Hospital of Stomatology

Study Record Dates

First Submitted

April 6, 2011

First Posted

April 13, 2011

Study Start

April 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2021

Last Updated

April 10, 2015

Record last verified: 2015-04

Locations

CN(4)