NCT00847717

Brief Summary

The treatment of clinically N0 neck in malignancies of oral cavity is controversial. The options include the policy of "wait and watch"(close observation and follow-up), elective irradiation of the neck, elective surgery of the neck (neck dissection). In elective neck dissections, the procedures commonly performed are modified radical neck dissection-III (functional neck dissection) and selective (supraomohyoid) neck dissection depending on the site of the primary lesion within the oral cavity. There are no trials of IIb preserving neck dissection in cancers of the oral cavity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2007

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

July 17, 2018

Status Verified

July 1, 2018

Enrollment Period

2 years

First QC Date

February 18, 2009

Last Update Submit

July 14, 2018

Conditions

Oral Cancer

Keywords

Oralcancersurgeryneck dissectionspinal accessory nerve

Outcome Measures

Primary Outcomes (1)

  • Spinal accessary nerve function

    2 years

Secondary Outcomes (1)

  • neck Node failure

    2 years

Study Arms (2)

1

EXPERIMENTAL

IIb preserving neck dissection

Procedure: Selective neck dissection

2

OTHER

Conventional neck dissection

Procedure: Conventional Neck dissection

Interventions

Selective neck dissectionPROCEDURE

Level IIb preserving neck dissection

1
Conventional Neck dissectionPROCEDURE

Conventional neck dissection (MRND type III or Supraomohyoid)

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients \>18yrs of age.
  • histologically proven squamous cell carcinoma
  • clinical and radiological N0 neck

You may not qualify if:

  • Pregnant and lactating women
  • Patients with synchronous primaries
  • H/o previous malignancy except BCC
  • Previous surgeries on neck
  • Post radiotherapy recurrence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Banaras Hindu University

Varanasi, Uttar Pradesh, 221005, India

Location

Related Publications (6)

  • Coskun HH, Erisen L, Basut O. Selective neck dissection for clinically N0 neck in laryngeal cancer: is dissection of level IIb necessary? Otolaryngol Head Neck Surg. 2004 Nov;131(5):655-9. doi: 10.1016/j.otohns.2004.04.014.

    PMID: 15523444BACKGROUND

  • Robbins KT, Doweck I, Samant S, Vieira F. Effectiveness of superselective and selective neck dissection for advanced nodal metastases after chemoradiation. Arch Otolaryngol Head Neck Surg. 2005 Nov;131(11):965-9. doi: 10.1001/archotol.131.11.965.

    PMID: 16301367BACKGROUND

  • Orhan KS, Demirel T, Baslo B, Orhan EK, Yucel EA, Guldiken Y, Deger K. Spinal accessory nerve function after neck dissections. J Laryngol Otol. 2007 Jan;121(1):44-8. doi: 10.1017/S0022215106002052. Epub 2006 Jul 3.

    PMID: 17040583BACKGROUND

  • van Wilgen CP, Dijkstra PU, Nauta JM, Vermey A, Roodenburg JL. Shoulder pain and disability in daily life, following supraomohyoid neck dissection: a pilot study. J Craniomaxillofac Surg. 2003 Jun;31(3):183-6. doi: 10.1016/s1010-5182(03)00030-1.

    PMID: 12818606BACKGROUND

  • Taylor RJ, Chepeha JC, Teknos TN, Bradford CR, Sharma PK, Terrell JE, Hogikyan ND, Wolf GT, Chepeha DB. Development and validation of the neck dissection impairment index: a quality of life measure. Arch Otolaryngol Head Neck Surg. 2002 Jan;128(1):44-9. doi: 10.1001/archotol.128.1.44.

    PMID: 11784253BACKGROUND

  • Pandey M, Karthikeyan S, Joshi D, Kumar M, Shukla M. Results of a randomized controlled trial of level IIb preserving neck dissection in clinically node-negative squamous carcinoma of the oral cavity. World J Surg Oncol. 2018 Nov 8;16(1):219. doi: 10.1186/s12957-018-1518-z.

    PMID: 30409212DERIVED

MeSH Terms

Conditions

Mouth NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteMouth DiseasesStomatognathic Diseases

Study Officials

  • Manoj Pandey, MS

    Banaras Hindu University

    PRINCIPAL INVESTIGATOR

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
Professor, Surgical Oncology

Study Record Dates

First Submitted

February 18, 2009

First Posted

February 19, 2009

Study Start

August 1, 2007

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

July 17, 2018

Record last verified: 2018-07

Locations

IN(1)