Evaluation and comparison of SNB and USgFNAC in the management of clinical negative neck in patients planned for transoral excision of oral and oropharyngeal squamous cell carcinoma.
ID
Source
Brief title
Condition
- Metastases
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is neck recurrence-free rate 3 years after registration in the
cohort of patients who are SNB negative at registration.
Secondary outcome
Secondary endpoints also include diagnostic value of SNB compared with USgFNAC.
Background summary
The management of the clinically negative (N0) neck in small oral and
oropharyngeal cancer is controversial issue. When there is merely a high
likelihood of occult lymph node metastases, the choice is between elective
treatment and watchful waiting. Because of the risk for under- and
overtreatment a sensitive and specific diagnostic technique is warranted. At
the VUmc US-guided fine needle aspiration cytology (USgFNAC) is routinely used
for the detection of occult lymph node metastases. The technique of sentinel
node biopsy (SNB) is a promising diagnostic technique which is nowadays
routinely used in other tumor types.
Study objective
Evaluation and comparison of SNB and USgFNAC in the management of clinical
negative neck in patients planned for transoral excision of oral and
oropharyngeal squamous cell carcinoma.
Study design
This is an observational non-randomized multicenter trial approved by EORTC. No
randomization is performed, because a randomized trial would have to test a
non-inferiority hypothesis and would require over 1000 patients. In the VU
medical center USgFNAC is added for comparison.
Intervention
Sentinel node biopsy procedure which includes injection of
radiolabeled-colloid, lymphoscintigraphy using a gamma camera and surgical
excision of the sentinel lymph node(s) during anesthesia for panendoscopy
Study burden and risks
In current clinical practice these patients undergo USgFNAC and/or further
imaging like CT, MRI or PET. Lymphoscintigraphy and sentinel node biopsy are
procedures which are used routinely in other tumor types. In the literature on
head and neck cancer no serious adverse events have been reported using these
techniques. Through a more extensive diagnostic work-up for staging the neck
the chance of missing occult lymph node metastases is decreased.
De Boelelaan 1117
1081 HV Amsterdam
Nederland
De Boelelaan 1117
1081 HV Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
oral / oropharyngeal squamous cell carcinoma
suitable for transoral excision
clinically negative neck (no lymph node metastases)
Exclusion criteria
previous treatment of the neck
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL13122.029.06 |