To prospectively document the introduction of the sentinel node procedure for bulky cT1-T2N0 nasal vestibule carcinoma in patients at risk of nodal involvement.
ID
Source
Brief title
Condition
- Other condition
- Skin neoplasms malignant and unspecified
Synonym
Health condition
hoofd hals maligniteiten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this study will be successful identification of
sentinel nodes on lymphoscintigraphy and SPECT imaging. The procedure will be
considered feasible when one or more sentinel nodes can be identified and
localized in at least 7 out of the 10 patients.
Secondary outcome
The secondary outcomes will be: yield of at least one lymph node after biopsy,
incidence of surgical complications and pain score during and after peritumoral
tracer injection and tracer.
Background summary
Management of the neck in Wang cT1-T2N0 nasal vestibule carcinoma (NVC) has
been an ongoing point of discussion. Due to the rarity of this disease,
regional recurrence rates vary widely between 0% up to 23%. In general,
literature recommends adequate neck staging followed by a watchful waiting
policy, as average regional recurrence rates are low (5-10%).
However, according to recent findings, a subset of patients with large or
voluminous cT1-T2N0 NVC is deemed at high risk of nodal involvement (20-40%
regional recurrence) but receive no elective treatment, although it is well
known that presence of nodal metastases impacts the prognosis of head and neck
cancer (HNC) dramatically. Whereas elective neck dissection may be too
aggressive, sentinel node biopsy (SNB) has been proven a reliable and safe
alternative to bridge the gap between imaging and neck dissection.
SNB is currently routinely employed in most HNC centres in the Netherlands and
is considered state of the art care, but its application in HNC is limited to
oral cavity carcinoma and squamous cell carcinoma of the skin. Following the
observation of increased risk of (occult) nodal metastases and regional
recurrence in bulky tumors, the sentinel node procedure seems ideally suited
for cT1-T2N0 NVC patients. Its superficial tumor localization is easily
accessible for peritumoral Tc-99m-nanocolloid-ICG tracer injection. The purpose
of this prospective registration study is to document the clinical introduction
of the sentinel node procedure for bulky nasal vestibule carcinoma in our
centre by protocol, and to identify and address possible unexpected
difficulties specific for this tumor site. Ultimately, the goal will be routine
and wide implementation of SNB in the NVC subgroup known to be at risk of nodal
involvement, as a means to improve regional disease staging and control.
Study objective
To prospectively document the introduction of the sentinel node procedure for
bulky cT1-T2N0 nasal vestibule carcinoma in patients at risk of nodal
involvement.
Study design
Prospective registration study.
Study burden and risks
The sentinel node procedure is considered state of the art care, but implies
additional invasive procedures for the patient. Therefore, proper introduction
by protocol and proper documentation are necessary. Prior to radiotherapy, 4
subcutaneous peritumoral injection with radioactive Tc-99m-nanocolloid-ICG will
be given at the Nuclear Medicine department, followed by SPECT imaging. Pain
may be experienced during tracer injection, which will be scored as one of the
study outcomes to assess tolerability. After tracer injection, patients will
undergo sentinel lymph node biopsy. They will be at low risk of minor surgical
complications such as postoperative hematoma or infection. This is offset by
possible earlier detection of otherwise occult nodal metastases and a
corresponding higher chance of curation by adequate neck treatment. The
sentinel node procedure will become the recommended neck staging tool, however,
patients will have the option to opt-out of the procedure and hence this study.
Geert Grooteplein Zuid 32
Nijmegen 6525GA
NL
Geert Grooteplein Zuid 32
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
* WHO performance score of 0, 1 or 2.
* Newly diagnosed T1 or T2 squamous cell carcinoma of the nasal vestibule.
* Tumor diameter *1.5 cm and/or tumor volume *1.5cm3
* Clinically negative neck (N0).
* Patients planned to undergo curative treatment.
Exclusion criteria
* Prior allergic reaction to either indocyanide green, 99m-Technetium
nanocolloid or human colloidal albumin.
* Pregnancy.
* Previous surgery or radiotherapy of the neck.
* Concurrent secondary head-and-neck tumor.
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 | NL70706.091.20 |