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Trial Title:
Sentinel NOSE Study: Prospective Registration Study on the Sentinel Node Procedure for Bulky Squamous Cell Carcinoma of the Nasal Vestibule.
NCT ID:
NCT05637307
Condition:
Squamous Cell Carcinoma of the Nasal Vestibule
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Conditions: Keywords:
nasal vestibule, sentinel node, nodal metastases
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Sentinel node procedure
Description:
Injection of radio-active tracer in the tumor before brachytherapy treatment,
visualization of sentinel nodes by SPECT, and extirpation of sentinel nodes by surgery
Arm group label:
sentinel node procedure
Summary:
Management of the neck in Wang cT1-T2N0 nasal vestibule carcinoma (NVC) has been an
ongoing point of discussion. As the disease is rare publications are scarce and published
regional recurrence rates vary widely between 0% up to 23%. In general, literature
recommends adequate radiological neck staging followed by a watchful waiting policy, as
overall 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.
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: Single centre prospective registration study. To be extended with a second
centre.
Study population: Patients with Wang cT1-T2N0 squamous cell carcinoma of the nasal
vestibule, with tumor diameter ≥1.5 cm and/or tumor volume ≥1.5 cm3, with a WHO
performance score of 2 or lower and no history of previous surgery or radiotherapy of the
neck.
Interventions: 1. Subcutaneous peritumoral radioactive tracer injection followed by
lymphoscintigraphy and Single Photon Emission Computed Tomography (SPECT) imaging for
sentinel lymph node visualization.
2. Surgical sentinel node biopsy and histopathological examination of harvested nodes
following the abovementioned imaging.
Main study parameters/endpoints: 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..
Detailed description:
Management of the neck in Wang cT1-T2N0 nasal vestibule carcinoma (NVC) has been an
ongoing point of discussion. As the disease is rare publications are scarce and published
regional recurrence rates vary widely between 0% up to 23%. In general, literature
recommends adequate radiological neck staging followed by a watchful waiting policy, as
overall 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.
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: Single centre prospective registration study. To be extended with a second
centre.
Study population: Patients with Wang cT1-T2N0 squamous cell carcinoma of the nasal
vestibule, with tumor diameter ≥1.5 cm and/or tumor volume ≥1.5 cm3, with a WHO
performance score of 2 or lower and no history of previous surgery or radiotherapy of the
neck.
Interventions: 1. Subcutaneous peritumoral radioactive tracer injection followed by
lymphoscintigraphy and Single Photon Emission Computed Tomography (SPECT) imaging for
sentinel lymph node visualization.
2. Surgical sentinel node biopsy and histopathological examination of harvested nodes
following the abovementioned imaging.
Main study parameters/endpoints: 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..
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Aged 18 years or older.
- 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.
- Patient provided written informed consent
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.
- Unable to provide informed consent
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Anthoni van Leeuwenhoekhuis
Address:
City:
Amsterdam
Zip:
1086 CX
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
Abrahim Al-Mamgami, MD, PHD
Facility:
Name:
Radboud UMC
Address:
City:
Nijmegen
Zip:
6500 HB
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Michal Czerwinski, MD
Phone:
00623172667
Email:
michal.czerwinski@radboudumc.nl
Contact backup:
Last name:
Lia Verhoef, MD, PhD
Phone:
00611079633
Email:
lia.verhoef@radboudumc.nl
Start date:
November 15, 2020
Completion date:
December 1, 2023
Lead sponsor:
Agency:
Radboud University Medical Center
Agency class:
Other
Source:
Radboud University Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05637307
