NCT00193765

Brief Summary

Cervical nodal metastasis is the single most important prognostic factor in head and neck cancers. Appropriate management of the neck is therefore of paramount importance in the treatment of these cancers. While it is obvious that the positive neck must be treated, controversy has always surrounded the clinically node negative neck with respect to the ideal treatment policy.The situation is difficult with regards to early cancers of the oral cavity (T1/T2). These cancers are usually treated with surgery where excision is through the per-oral route. Elective neck dissection in such a situation is an additional surgical procedure with its associated costs, prolonged hospitalization and may be unnecessary in as high as 80% of patients who finally turn out to be pathologically node negative. Should the neck be electively treated or there be a wait and watch policy? Current practice is that the neck is always addressed whenever there is an increased propensity to cervical metastasis or when patient follow-up is unreliable. There is clearly a need therefore for a large randomized trial that will resolve the issue either way once and for all. Primary Objective: To demonstrate whether elective neck dissection (END) is equal or superior to the wait and watch policy i.e. therapeutic neck dissection (TND) in the management of the clinically No neck in early T1 /T2 cancers of the oral cavity. Secondary Objective:

  1. 1.Does Ultrasound examination have any role in the routine initial workup of a node negative patient?
  2. 2.How are patients ideally followed up -does sonography have a role or is clinical examination sufficient.
  3. 3.Is assessment of tumor thickness by the surgeon at the time of initial surgery accurate -Is there a correlation
  4. 4.Identify histological prognostic factors in the primary that may help identify a sub-set of patients at an increased risk for cervical metastasis.

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
710

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
13.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

June 16, 2017

Status Verified

June 1, 2017

Enrollment Period

15.4 years

First QC Date

September 13, 2005

Last Update Submit

June 15, 2017

Conditions

Oral Cancer

Keywords

neck dissectionsurvivalearly oral cancerEarly oral cavity squamous cancer with node negative neck

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    survival would be calculated as time period between date of randomization and date of death from any cause or last follow up

    5 years

Secondary Outcomes (5)

  • Disease free survival

    5 years

  • Role of ultrasound examination in routine initial workup of a node negative patient.

    5 years

  • Role of ultrasonogrphy vs clinical examination in ideal follow up of patient.

    5 years

  • Correlation between the tumour thickness assessment by surgeon on table , on frozen section and final histopathology.

    Within 2 weeks after surgery

  • Identify histological prognostic factors in primary that may help identify a sub-set of patients at an increased risk of cervical metastasis.

    upto 5 years

Study Arms (2)

Wait and Watch

ACTIVE COMPARATOR

Therapeutic neck dissection on developing nodal relapse

Procedure: Therapeutic Neck Dissection

Elective Neck dissection

EXPERIMENTAL

Elective neck dissection in early oral cancer at the time of primary surgery

Procedure: Elective neck dissection in early oral cancer

Interventions

Elective neck dissection in early oral cancerPROCEDURE

Elective neck dissection in early node negative oral cancers at the time of primary surgery

Also known as: Early oral cancer, Node negative neck
Elective Neck dissection
Therapeutic Neck DissectionPROCEDURE

There is no active intervention for the neck at the time of primary surgery. Therapeutic Neck Dissection at the time of nodal relapse

Also known as: Wait & Watch
Wait and Watch

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven T1 or T2 N0 M0 (clinical) squamous cell carcinoma of the buccal mucosa, lower alveolus, oral tongue and floor of mouth.
  • Surgery is the preferred treatment and the primary tumor can be excised with clear margins via the per-oral route.
  • No history of a prior malignancy in the head and neck region.
  • No prior malignancy outside the head and neck region in the preceding 5 years.
  • Patient will be reliable for follow-up
  • Age\> 18 years and \< 75 years.
  • No significant co-morbid conditions - ASA grade II and I.
  • Understands the protocol and is able to give informed consent.

You may not qualify if:

  • Prior radiotherapy or surgery for malignancy in the head and neck region.
  • Non squamous cell carcinomas of the oral cavity.
  • Upper alveolus and palatal lesions where there is a possibility of retropharyngeal node involvement.
  • Per-oral excision of tumor will compromise margins in the opinion of the treating surgeon.
  • Significant co-existing pre-malignant conditions like erytho-leucoplakia and oral sub mucous fibrosis that in the opinion of the clinician would interfere in the planned treatment management of the patient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

Location

Related Publications (2)

  • 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

  • D'Cruz AK, Vaish R, Kapre N, Dandekar M, Gupta S, Hawaldar R, Agarwal JP, Pantvaidya G, Chaukar D, Deshmukh A, Kane S, Arya S, Ghosh-Laskar S, Chaturvedi P, Pai P, Nair S, Nair D, Badwe R; Head and Neck Disease Management Group. Elective versus Therapeutic Neck Dissection in Node-Negative Oral Cancer. N Engl J Med. 2015 Aug 6;373(6):521-9. doi: 10.1056/NEJMoa1506007. Epub 2015 May 31.

    PMID: 26027881DERIVED

MeSH Terms

Conditions

Mouth Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic Diseases

Study Officials

  • Anil K D'cruz, MS,DNB

    Tata Memorial Hospital,Mumbai,India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MS, DNB, FRCS (Hon.)

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

January 1, 2004

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

June 16, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)