To prospectively evaluate the oncologic safety of selective SPECT/CT-guided ENI in a larger cohort of HNSCC patients
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cumulative incidence of contralateral regional metastasis at 1 year after
treatment
Secondary outcome
Toxicity
Quality of Life
Prevalence of metastatic disease in contralateral sentinel nodes removed based
on lymph drainage mapping using SPECT/CT at baseline
Background summary
Most patients with head and neck squamous cell carcinoma (HNSCC) receive
electively nodal irradiation (ENI) to both sides of the neck in order to reduce
the risk of contralateral regional failure (cRF). However, there is increasing
evidence that the incidence of cRF in lateralized HNSCC is very low (<10%).
Bilateral ENI, as compared to unilateral ENI, is associated with higher
incidence of acute and late radiation-induced toxicity with subsequent
deterioration of quality-of-life (QoL). One way to reduce the incidence,
duration and severity of these toxicities is by implementation of unilateral
ENI, in patients where this can be justified.
The first SUSPECT study (N14SUS) investigated whether lymph drainage mapping
(LDM) using Single Photon Emission Computed Tomography/Computed Tomography
(SPECT/CT) was a safe and feasible method to exclude the contralateral neck
from irradiation, or, in case of contralateral lymph drainage, to tailor the
contralateral ENI field to the level containing the tracer accumulation (*hot
spot*). Large dose reductions to most organs at risk were realized, as well as
significant reductions of both short term (mucositis, dysphagia) and long term
(xerostomia, dysphagia) toxicities (to be published).
The SUSPECT-2 study aims to further reduce the proportion of patients that
undergoes conventional bilateral ENI, by performing a contralateral sentinel
node procedure (SNP) in case of contralateral lymph drainage; and to expand the
inclusion criteria of the SUSPECT-1 study.
Study objective
To prospectively evaluate the oncologic safety of selective SPECT/CT-guided ENI
in a larger cohort of HNSCC patients
Study design
Prospective multicentre phase II trial
Intervention
Injection of radioactive tracer submucosally around and in the tumor;
subsequently lymph drainage mapping using SPECT/CT and contralateral sentinel
node procedure (in case of contralateral lymph drainage). Unilateral or
bilateral elective nodal irradiation based on results SPECT/CT and sentinel
node procedure.
Study burden and risks
Subjects in this study will undergo a lymph drainage mapping using SPECT/CT,
which will have the advantage of sparing about 80% of the patients from
contralateral elective nodal irradiation altogether. The remaining 20% will
undergo removal of the contralateral sentinel node by means of a minimally
invasive procedure, but the majority of those patients will need no further
treatment of the contralateral neck, instead of being treated with
contralateral ENI and risking its associated short and long term toxicity.
Plesmanlaan 121
AMSTERDAM 1066CX
NL
Plesmanlaan 121
AMSTERDAM 1066CX
NL
Listed location countries
Age
Inclusion criteria
• Newly diagnosed and histopathologically proven lateralized primary HNSCC,
T1-4N0-2b without midline involvement, originating at one side of the oral
cavity, oropharynx, larynx (except T1 glottic), and hypopharynx, and planned
for treatment with primary radiotherapy, chemo-radiotherapy or
immuno-radiotherapy in curative setting
• Age >= 18 years
• WHO performance status 0 or 1
• Signed written informed consent
Exclusion criteria
• Distant metastatic spread at the time of inclusion
• Chemotherapy or surgery (for the present tumor), prior to inclusion
• Previous radiation treatment in the head and neck region, for any reason
• Previous neck dissection
• Recurrent or second primary tumor in the head and neck region
• Head and neck malignancies arising from skin, lip, nose, sinuses,
nasopharynx, salivary glands, thyroid gland or esophagus
• Pregnancy or no active contraception for pre-menopausal women
• Known hypersensitivity to iodine or nanocolloid injection
• Having any condition (physical, mental, sociological) that interferes with
the informed consent procedure and follow-up schedules
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 | NL68958.031.19 |