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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00193765
Recruitment Status : Unknown
Verified June 2017 by A K D'Cruz, Tata Memorial Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 19, 2005
Last Update Posted : June 16, 2017
Information provided by (Responsible Party):
A K D'Cruz, Tata Memorial Hospital

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. 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.

Condition or disease Intervention/treatment Phase
Oral Cancer Procedure: Elective neck dissection in early oral cancer Procedure: Therapeutic Neck Dissection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 710 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Elective Versus Therapeutic Neck Dissection in the Treatment of Early Node Negative Squamous Cell Carcinoma of the Oral Cavity
Study Start Date : January 2004
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oral Cancer

Arm Intervention/treatment
Active Comparator: Wait and Watch
Therapeutic neck dissection on developing nodal relapse
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
Other Name: Wait & Watch

Experimental: Elective Neck dissection
Elective neck dissection in early oral cancer at the time of primary surgery
Procedure: Elective neck dissection in early oral cancer
Elective neck dissection in early node negative oral cancers at the time of primary surgery
Other Names:
  • Early oral cancer
  • Node negative neck

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 5 years ]
    survival would be calculated as time period between date of randomization and date of death from any cause or last follow up

Secondary Outcome Measures :
  1. Disease free survival [ Time Frame: 5 years ]
    the interval between the date of randomization and the date of the first documented evidence of relapse at any site (local, regional, metastatic, or second primary) or death from any cause, whichever came first

  2. Role of ultrasound examination in routine initial workup of a node negative patient. [ Time Frame: 5 years ]
    to see that the addition of USG to routine initial work up helps in detection of cervical metastasis better

  3. Role of ultrasonogrphy vs clinical examination in ideal follow up of patient. [ Time Frame: 5 years ]
    to see if the addition of USG to routione clinical examination helps in early detection of the cervical metastasis and hence improves survival

  4. Correlation between the tumour thickness assessment by surgeon on table , on frozen section and final histopathology. [ Time Frame: Within 2 weeks after surgery ]
    to assess the concordance between the assessment on table by surgeon, pathologist at frozen section and histopathology taking histopathology as gold standard

  5. Identify histological prognostic factors in primary that may help identify a sub-set of patients at an increased risk of cervical metastasis. [ Time Frame: upto 5 years ]
    statistical analysis to identify the factors predicting cervical metastasis

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  1. Prior radiotherapy or surgery for malignancy in the head and neck region.
  2. Non squamous cell carcinomas of the oral cavity.
  3. Upper alveolus and palatal lesions where there is a possibility of retropharyngeal node involvement.
  4. Per-oral excision of tumor will compromise margins in the opinion of the treating surgeon.
  5. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00193765

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Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012
Sponsors and Collaborators
Tata Memorial Hospital
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Principal Investigator: Anil K D'cruz, MS,DNB Tata Memorial Hospital,Mumbai,India
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: A K D'Cruz, MS, DNB, FRCS (Hon.), Tata Memorial Hospital Identifier: NCT00193765    
Other Study ID Numbers: TMH/131/2003
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by A K D'Cruz, Tata Memorial Hospital:
neck dissection
early oral cancer
Early oral cavity squamous cancer with node negative neck
Additional relevant MeSH terms:
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Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases