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Trial Title:
Sentinel Node Biopsy Versus Limited Elective Neck Dissection in Early Cancers of Oral Cavity NoDe Negative
NCT ID:
NCT05774483
Condition:
Mouth Neoplasms
Conditions: Official terms:
Mouth Neoplasms
Conditions: Keywords:
mouth neoplasms
neck dissection
sentinel lymph node biopsy
survival
morbidity
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Sentinel Node Biopsy
Description:
The Sentinel node will be localized after injecting peritumoral nano colloid followed by
dynamic lymphoscintigraphy and SPECT localization. Methylene blue or indocyanine green
may be used but not mandatory as an adjunct for lymphoscintigraphy for node localization.
Intraoperatively the node will be identified using a hand-held gamma probe. The sentinel
node will be processed on a frozen section, histopathological processing with serial step
sectioning, and immunohistochemistry. If reported as metastatic, then a single-stage or
second-stage completion neck dissection will be performed.
Arm group label:
Sentinel node biopsy
Intervention type:
Procedure
Intervention name:
Limited Elective Neck Dissection
Description:
Patients who are allocated to the limited END arm will undergo dissection of level I, IIa
and III/IV nodes sparing level IIb. Level IIa will be subjected to a frozen section and
if reported as metastatic will mandate clearance of level IIb.
Arm group label:
Limited elective neck dissection
Summary:
The goal of this clinical trial is to compare the survival outcomes, morbidity and
cost-effectiveness of sentinel node biopsy versus limited elective neck dissection in
node-negative early oral cancers.
The main questions it aims to answer are:
- Survival outcomes
- Morbidity outcomes
- Cost-effectiveness
Participants will either undergo sentinel node biopsy followed by completion neck
dissection if sentinel node is reported to be metastatic (SNB) or limited elective neck
dissection where level IIb will be cleared only if level IIa is metastatic (limited END).
The study will compare the outcomes in the two cohorts.
Detailed description:
Based on the current literature, we know that elective neck dissection (END) is mandatory
in clinically node-negative early oral cancers. However, this leads to overtreatment and
morbidity in about 55-80% of patients. The emergence of recent level I evidence makes SNB
the standard of care in this setting. However, its limitation of being a two-staged
procedure, steep learning curve, the burden on resources, lack of infrastructure,
short-lasting decrease in morbidity and lack of cost-effectiveness data limits its wide
applicability. It is our routine departmental practice of performing limited neck
dissection clearing level I-III/IV sparing level IIb which is cleared only if level IIa
is metastatic. It is hypothesized that limited END would limit the morbidity of shoulder
dysfunction and be a more feasible and cost-effective treatment option which could be a
suitable alternative to SNB in this setting without compromising the survival outcomes.
With this background, we propose to embark upon a phase III RCT comparing the oncologic
outcomes and morbidity of SNB versus limited END. We hypothesize that limited END would
have survival outcomes non-inferior, morbidity similar to SNB with higher
cost-effectiveness.
Aims and objectives:
Aim To compare the survival outcomes, morbidity and cost-effectiveness of SNB versus
limited END in node-negative early oral cancers
Primary objective
1) Overall survival
Secondary objectives
1. Shoulder morbidity (key secondary endpoint) longitudinally up to 2 years
2. Disease-free survival
3. Neck nodal recurrence-free survival
4. Other side effects (chyle leak, hematoma, lymphoedema)
5. Longitudinal Quality of life up to 2 years
6. Cost-effective analysis
Exploratory objectives Blood and tumour tissue will be collected and banked for biomarker
studies. Exploratory analyses will be conducted at a later date. Efforts may be directed
to identify the biomarkers to predict nodal metastasis.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age >18 years of age
2. Biopsy-proven invasive squamous cell carcinoma involving the site tongue and buccal
mucosa
3. T1 and T2 lesions as per AJCC TNM 8 edition
4. Clinicoradiologically node negative
5. Amenable to per oral excision
6. Treatment naïve
7. No other site of malignancy
Exclusion Criteria:
1. Previous surgery in the head and neck region,
2. Upper alveolar or palatal lesions
3. Large heterogeneous leukoplakia or other premalignant lesions
4. Previous malignancy in the head and neck region
5. Patients requiring the free flap reconstruction
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tata Memorial Hospital
Address:
City:
Mumbai
Zip:
400012
Country:
India
Status:
Recruiting
Contact:
Last name:
Richa Vaish, MS, M.Ch
Phone:
022-24177000
Phone ext:
7238
Email:
drvaishricha@gmail.com
Facility:
Name:
ACTREC
Address:
City:
Navi Mumbai
Country:
India
Status:
Not yet recruiting
Contact:
Last name:
Richa Vaish, MS, M.Ch
Phone:
022-24177000
Email:
drvaishricha@gmail.com
Start date:
November 2024
Completion date:
April 2034
Lead sponsor:
Agency:
Tata Memorial Hospital
Agency class:
Other
Collaborator:
Agency:
Tata Memorial Centre
Agency class:
Other
Source:
Tata Memorial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05774483
