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

This study is currently recruiting participants.
Verified June 2012 by Tata Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
A K D'Cruz, Tata Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00193765
First received: September 13, 2005
Last updated: June 1, 2012
Last verified: June 2012
History of Changes
  Purpose

Cervical 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 between tumor thickness as measured grossly by the surgeon, at frozen section versus final histopathology.
  4. Identify histological prognostic factors in the primary that may help identify a sub-set of patients at an increased risk of cervical metastasis.

Condition Intervention Phase
Oral Cancer
 Procedure: Elective Vs Therapeutic neck dissection in early oral cancer
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Oral Cancer
U.S. FDA Resources

Further study details as provided by Tata Memorial Hospital:

Primary Outcome Measures:
  • Survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Does Ultrasound examination have any role in the routine initial workup of a node negative patient? [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • How are patients ideally followed up -does sonography have a role or is clinical examination sufficient. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Is assessment of tumor thickness by the surgeon at the time of initial surgery accurate -Is there a correlation [ Time Frame: Within 2 weeks after surgery ] [ Designated as safety issue: No ]
  • Identify histological prognostic factors in the primary that may help identify a sub-set of patients at an increased [ Time Frame: upto 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 710
Study Start Date: January 2004
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Elective Neck dissection
 Procedure: Elective Vs Therapeutic neck dissection in early oral cancer
Elective neck dissection in early node negative oral cancers
Other Names:
  • Early oral cancer
  • Node negative neck
Experimental: 2
Wait and Watch
 Procedure: Elective Vs Therapeutic neck dissection in early oral cancer
Elective neck dissection in early node negative oral cancers
Other Names:
  • Early oral cancer
  • Node negative neck

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00193765

Contacts
Contact: Anil K Dcruz, MS,DNB 91-22-2417-7000 ext 7278 adcruz@vsnl.com
Contact: Rohini W Hawaldar, B.Sc,DCM 91-22-2416-8601 tmhcrs@vsnl.com

Locations
India
Tata Memorial Hospital Recruiting
Mumbai, Maharashtra, India, 400012
Contact: Anil K D'cruz, MS,DNB     91-22-2417-7000 ext 7278     adcruz@vsnl.com    
Contact: Devendra A Chaukar, MS,DNB     91-22-2417-7000 ext 7238     dchaukar@rediffmail.com    
Principal Investigator: Anil K D'cruz, MS,DNB            
Sub-Investigator: Devendra A Chaukar, MS,DNB            
Sponsors and Collaborators
Tata Memorial Hospital
Investigators
Principal Investigator: Anil K D'cruz, MS,DNB Tata Memorial Hospital,Mumbai,India
  More Information

No publications provided

Responsible Party: A K D'Cruz, MS, DNB, Tata Memorial Hospital
ClinicalTrials.gov Identifier: NCT00193765     History of Changes
Other Study ID Numbers: TMH/131/2003
Study First Received: September 13, 2005
Last Updated: June 1, 2012
Health Authority: India: Department of Atomic Energy

Keywords provided by Tata Memorial Hospital:
neck dissection
survival
early oral cancer
Early oral cavity squamous cancer with node negative neck

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Mouth Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 16, 2013