Elective vs Therapeutic Neck Dissection in Treatment of Early Node Negative Squamous Carcinoma of Oral Cavity
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|ClinicalTrials.gov 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
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.
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.
- Does Ultrasound examination have any role in the routine initial workup of a node negative patient?
- How are patients ideally followed up -does sonography have a role or is clinical examination sufficient.
- Is assessment of tumor thickness by the surgeon at the time of initial surgery accurate -Is there a correlation
- 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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||710 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
- 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
- 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
- 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
- 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
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT00193765
|Tata Memorial Hospital|
|Mumbai, Maharashtra, India, 400012|
|Principal Investigator:||Anil K D'cruz, MS,DNB||Tata Memorial Hospital,Mumbai,India|