This study aims to explore the rate of contralateral lymphatic drainage and occult contralateral metastases in patients with lateralized OSCC, a clinically negative contralateral neck and clinical ipsilateral lymph node metastases metastases or a…
ID
Source
Brief title
Condition
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The rate of contralateral lymphatic drainage and occult CLNM in patients with
lateralized OSCC, a clinically negative contralateral neck and a clinically
ipsilateral positive neck metastases or a clinically negative ipsilateral neck
in advanced stage OSCC.
Secondary outcome
Not applicable
Background summary
In oral squamous cell carcinoma (OSCC), contralateral lymph node metastases
(CLNM) strongly correlates with poor prognosis. Numerous studies have shown
survival benefit of elective neck dissection (END), as compared to therapeutic
neck dissection in clinically node-negative (cN0) OSCC patients. However, in
regard of the clinically negative contralateral neck in OSCC patients, there is
an ongoing discussion concerning the benefit of elective treatment. This debate
is sustained by the varying incidence of CLNM in OSCC among institutions
(0.9%-36%). Because of confusing guidelines and the relatively low incidence of
CLNM, many patients will receive unnecessary treatment of the contralateral
clinically negative neck. Whereas neck dissection and irradiation of the neck
are associated with significant morbidity. Sentinel lymph node biopsy (SLNB)
might offer a solution to the dilemma that arises in the clinically negative
contralateral neck in patients with lateralized OSCC and ipsilateral lymph node
metastases. Since SLNB would enable to accurately select those that are
eligible for treatment of the contralateral neck. Thus, avoiding overtreatment
of the contralateral neck, since only those with positive contralateral
sentinel lymph nodes (SLN) will be eligible for additional treatment of the
contralateral neck.
Study objective
This study aims to explore the rate of contralateral lymphatic drainage and
occult contralateral metastases in patients with lateralized OSCC, a clinically
negative contralateral neck and clinical ipsilateral lymph node metastases
metastases or a clinically negative ipsilateral neck in advanced stage OSCC,
with SLNB. Secondly, we aim to investigate whether a full-sized study (n=180)
regarding the incidence of (occult) contralateral metastases in patients
lateralized OSCC, a clinically negative contralateral neck and clinical
ipsilateral lymph node metastases or a clinically negative ipsilateral neck in
advanced stage OSCC, by means of SLNB, is eligible.
Study design
The proposed study is designed as a prospective single-center pilot study and
will be conducted in the UMC Utrecht.
Intervention
All patients will undergo additional lymphoscintigraphy. In those with
contralateral lymphatic drainage, additional SLNB of the contralateral neck
will be performed simultaneous to standard surgery (i.e. tumor resection and
ipsilateral neck dissection).
Study burden and risks
Extra burden for patients concerns additional lymphoscintigraphy and any
additional dissection of SLN(s) in the contralateral neck. Complications after
SLNB are uncommon and there is substantial experience in the UMC Utrecht
regarding lymphoscintigraphy and SLNB. Besides, patients may also benefit from
the study, as occult contralateral cervical metastases can be detected and
treated at an early stage, which implies better oncological outcome. Therefore,
the risks of participation in this study are considered acceptable for the
subjects.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
1. The patient has provided written informed consent authorization before
participating in the study.
2. The patient has a diagnosis of primary lateralized oral squamous cell
carcinoma, that does not involve the midline and is anatomically located in:
mucosal lip, buccal mucosa, lower alveolar ridge, upper alveolar ridge,
retromolar gingiva (retromolar trigone), floor-of-the-mouth, hard palate or
oral (mobile) tongue.
3. Clinical nodal staging of the positive ipsilateral neck (N1-N3) or a
negative ipsilaterale neck (N0) in case of T3-T4 primary lateralized oral
squamous cell carcinoma, has been confirmed by ultrasound, MRI and/or fine
needle aspiration cytology within 30 days of the SLN procedure.
4. Clinical nodal staging of the negative contralateral neck (N0) has been
confirmed by neg-ative results from ultrasound, MRI and/or fine needle
aspiration cytology within 30 days of the SLN procedure.
5. The patient is a candidate for surgical tumor resection and ipsilateral neck
dissection.
6. Patients with prior malignancy in the head and neck area are allowed,
provided the patient meets both of the following criteria:
• Underwent potentially curative therapy for all prior head and neck
malignancies and is deemed low risk for recurrence; and
• No head and neck malignancy for the past five years (except effectively
treated basal cell or squamous cell skin cancer) and no evidence of recurrence.
7. The patient is >=18 years of age at the time of consent.
8. The patient has an ECOG status of Grade 0-2.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
1. The patient has a diagnosis of squamous cell carcinoma of the head and neck
in the fol-lowing anatomical areas: non-mobile base of the tongue, oropharynx,
nasopharynx, hy-popharynx, and larynx.
2. The patient is incapacitated.
3. The patient has had a previous allergic reaction after administration of a
radionuclide tracer.
4. The patient has had other nuclear imaging studies, conducted within 2 days
(48 hours) of injection.
5. The patient has a history of neck dissection, or gross injury to the neck
that would pre-clude reasonable surgical dissection for this trial, or
radiotherapy to the neck.
6. The patient is actively receiving systemic cytotoxic chemotherapy.
7. The patient is on immunosuppressive, anti-monocyte, or immunomodulatory
therapy.
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 | NL71228.041.19 |