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Elective vs Therapeutic Neck Dissection in Treatment of Early Node Negative Squamous Carcinoma of Oral Cavity

NCT00193765 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 710

Last updated 2017-06-16

No results posted yet for this study

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

Conditions

  • Oral Cancer

Interventions

PROCEDURE

Elective neck dissection in early oral cancer

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

PROCEDURE

Therapeutic Neck Dissection

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

Sponsors & Collaborators

  • Tata Memorial Hospital

    lead OTHER_GOV

Principal Investigators

  • Anil K D'cruz, MS,DNB · Tata Memorial Hospital,Mumbai,India

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2019-06-30
Completion
2019-06-30

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00193765 on ClinicalTrials.gov