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Sentinel Node Biopsy in Early Oral Cancers a Tertiary Cancer Centre Experience

Primary Purpose

Oral Cavity Squamous Cell Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Sentinel node biopsy
Sponsored by
Tata Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Cavity Squamous Cell Carcinoma focused on measuring oral neoplasm, sentinel node biopsy, node negative

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age between 18 to 75 years of age, Biopsy-proven invasive squamous cell carcinoma involving site among tongue and buccal mucosa T1 and T2 lesions as per AJCC TNM classification Clinicoradiologically node negative Amenable to per oral excision Exclusion Criteria: Upper alveolar or palatal lesions Large heterogeneous leukoplakia or other premalignant lesion T3/T4 lesions Lesions requiring raising of cheek flap to access for excision

Sites / Locations

  • Tata Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

sentinel node biopsy

Arm Description

All patients have undergone completion neck dissection following SNB in the process of standardization. The SNB was localized by peritumoral infiltration of the nano colloid, followed by dynamic planar imaging for 30 minutes, and then SPECT was performed. The surgery was performed on the same day within 6 hours of localisation, and intraoperatively, either methylene blue or indocyanine green was used as an adjunct. Appropriately labelled sentinel nodes were assessed on the frozen section, which was then sectioned into 2-3mm slices perpendicular to the longest axis of the node and submitted entirely for microscopic evaluation. A minimum of 2 sections were evaluated, one stained with Toluidine blue and the other with rapid Haematoxylin and Eosin (HE) stain. The nodes were subsequently subjected to histopathological processing.

Outcomes

Primary Outcome Measures

Diagnostic accuracy of the SNB
Sensitivity, specificity, negative predictive value, positive predictive value, False negative rate, SNB identification rate

Secondary Outcome Measures

To study the pattern of metastasis in sentinel and non-sentinel nodes
Level-wise frequency of SN metastasis, Frequency of metastasis in the SN basin, Frequency of metastasis to extra sentinel nodal basin

Full Information

First Posted
July 7, 2023
Last Updated
July 15, 2023
Sponsor
Tata Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05950737
Brief Title
Sentinel Node Biopsy in Early Oral Cancers a Tertiary Cancer Centre Experience
Official Title
Sentinel Node Biopsy in Early Oral Cancers a Tertiary Cancer Centre Experience
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
July 15, 2023 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tata Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Sentinel node biopsy is a suitable alternative to END and is recommended in standard guidelines. Investigators have been doing SNB in their department to standardize the process for the last two years. This study aims to analyze the diagnostic accuracy of the SNB performed to standardize the procedure at their institute.
Detailed Description
Elective neck dissection (END) is the standard of care in node-negative early oral cancers. However, it is associated with morbidity predominantly of shoulder dysfunction. Moreover, nearly 55-70% are true node-negative and are over-treated with this approach. Attempts have been made to overcome this limitation and to identify true node-negative patients. Sentinel node biopsy has shown the highest diagnostic accuracy among all other options. The SN is the first echelon node that drains directly through the lymphatics from the primary tumour. The principle of SNB is based on the fact that since it is the first echelon node, it would be the first site of regional metastasis. Therefore, the metastasis is unlikely to involve other nodal levels if the SNB is negative. It is the standard of care in breast cancers and melanoma. The concept made its way into oral cavity tumours and has been explored for over a decade in this setting. The results of the multi-institutional trial by Civantos et al. reported a high NPV of 94% of this procedure in early oral cancers that were node negative. Since then, various meta-analyses have shown that SNB has a high NPV making it a strong diagnostic modality. Schilling et al. reported the 3-year results of SNB in oral cancers in a multicentric study comprising 415 patients. The authors successfully identified the SN in 99.5% of cases and reported an FNR of 14%, which was high. Despite this, the study showed a high 3-year-disease-specific survival of 94%. Recently published Phase III Randomized controlled trials have shown that the overall survival of sentinel node biopsy is comparable to END with lesser morbidity in shoulder dysfunction. The advantage of the procedure is that only 25-30% of the patients who are SNB positive need to undergo neck dissection, and it spares unnecessary neck clearance and hence limits the morbidity in the remaining 70-75% of cases. SNB is a suitable alternative to END and is recommended in standard guidelines. However, SNB has a learning curve, it is recommended that the process be standardized, and the team should perform adequate SNB, followed by the completion of neck dissection before sparing the neck based on SNB. Investigators have been doing SNB in their department to standardize the process following the publication of level I evidence. This study aims to analyze the diagnostic accuracy of the SNB performed to standardize the procedure at the investigator's institute.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Cavity Squamous Cell Carcinoma
Keywords
oral neoplasm, sentinel node biopsy, node negative

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sentinel node biopsy
Arm Type
Experimental
Arm Description
All patients have undergone completion neck dissection following SNB in the process of standardization. The SNB was localized by peritumoral infiltration of the nano colloid, followed by dynamic planar imaging for 30 minutes, and then SPECT was performed. The surgery was performed on the same day within 6 hours of localisation, and intraoperatively, either methylene blue or indocyanine green was used as an adjunct. Appropriately labelled sentinel nodes were assessed on the frozen section, which was then sectioned into 2-3mm slices perpendicular to the longest axis of the node and submitted entirely for microscopic evaluation. A minimum of 2 sections were evaluated, one stained with Toluidine blue and the other with rapid Haematoxylin and Eosin (HE) stain. The nodes were subsequently subjected to histopathological processing.
Intervention Type
Procedure
Intervention Name(s)
Sentinel node biopsy
Intervention Description
All patients have undergone completion neck dissection following SNB in the process of standardization.
Primary Outcome Measure Information:
Title
Diagnostic accuracy of the SNB
Description
Sensitivity, specificity, negative predictive value, positive predictive value, False negative rate, SNB identification rate
Time Frame
Through study completion, an average of 2 year
Secondary Outcome Measure Information:
Title
To study the pattern of metastasis in sentinel and non-sentinel nodes
Description
Level-wise frequency of SN metastasis, Frequency of metastasis in the SN basin, Frequency of metastasis to extra sentinel nodal basin
Time Frame
Through study completion, an average of 2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18 to 75 years of age, Biopsy-proven invasive squamous cell carcinoma involving site among tongue and buccal mucosa T1 and T2 lesions as per AJCC TNM classification Clinicoradiologically node negative Amenable to per oral excision Exclusion Criteria: Upper alveolar or palatal lesions Large heterogeneous leukoplakia or other premalignant lesion T3/T4 lesions Lesions requiring raising of cheek flap to access for excision
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richa Vaish, MS, M.Ch
Phone
24177000
Ext
7238
Email
drvaishricha@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richa Vaish, MS. M.Ch
Organizational Affiliation
Tata Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tata Memorial Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richa Vaish, MS. M.Ch

12. IPD Sharing Statement

Citations:
PubMed Identifier
26027881
Citation
D'Cruz AK, Vaish R, Kapre N, Dandekar M, Gupta S, Hawaldar R, Agarwal JP, Pantvaidya G, Chaukar D, Deshmukh A, Kane S, Arya S, Ghosh-Laskar S, Chaturvedi P, Pai P, Nair S, Nair D, Badwe R; Head and Neck Disease Management Group. Elective versus Therapeutic Neck Dissection in Node-Negative Oral Cancer. N Engl J Med. 2015 Aug 6;373(6):521-9. doi: 10.1056/NEJMoa1506007. Epub 2015 May 31.
Results Reference
background
PubMed Identifier
20142602
Citation
Civantos FJ, Zitsch RP, Schuller DE, Agrawal A, Smith RB, Nason R, Petruzelli G, Gourin CG, Wong RJ, Ferris RL, El Naggar A, Ridge JA, Paniello RC, Owzar K, McCall L, Chepeha DB, Yarbrough WG, Myers JN. Sentinel lymph node biopsy accurately stages the regional lymph nodes for T1-T2 oral squamous cell carcinomas: results of a prospective multi-institutional trial. J Clin Oncol. 2010 Mar 10;28(8):1395-400. doi: 10.1200/JCO.2008.20.8777. Epub 2010 Feb 8.
Results Reference
background
PubMed Identifier
23263205
Citation
Thompson CF, St John MA, Lawson G, Grogan T, Elashoff D, Mendelsohn AH. Diagnostic value of sentinel lymph node biopsy in head and neck cancer: a meta-analysis. Eur Arch Otorhinolaryngol. 2013 Jul;270(7):2115-22. doi: 10.1007/s00405-012-2320-0. Epub 2012 Dec 22.
Results Reference
background
PubMed Identifier
33602650
Citation
Mallo Magarinos M, Suarez Ajuria M, Marichalar Mendia X, Alvarez-Calderon Iglesias O, Chamorro Petronacci CM, Garcia Garcia A, Perez Sayans M. Diagnostic yield of sentinel lymph node biopsy in oral squamous cell carcinoma T1/T2-N0: systematic review and meta-analysis. Int J Oral Maxillofac Surg. 2021 Oct;50(10):1271-1279. doi: 10.1016/j.ijom.2021.01.020. Epub 2021 Feb 16.
Results Reference
background
PubMed Identifier
28900723
Citation
Yang Y, Zhou J, Wu H. Diagnostic value of sentinel lymph node biopsy for cT1/T2N0 tongue squamous cell carcinoma: a meta-analysis. Eur Arch Otorhinolaryngol. 2017 Nov;274(11):3843-3852. doi: 10.1007/s00405-017-4740-3. Epub 2017 Sep 12.
Results Reference
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PubMed Identifier
26597442
Citation
Schilling C, Stoeckli SJ, Haerle SK, Broglie MA, Huber GF, Sorensen JA, Bakholdt V, Krogdahl A, von Buchwald C, Bilde A, Sebbesen LR, Odell E, Gurney B, O'Doherty M, de Bree R, Bloemena E, Flach GB, Villarreal PM, Fresno Forcelledo MF, Junquera Gutierrez LM, Amezaga JA, Barbier L, Santamaria-Zuazua J, Moreira A, Jacome M, Vigili MG, Rahimi S, Tartaglione G, Lawson G, Nollevaux MC, Grandi C, Donner D, Bragantini E, Dequanter D, Lothaire P, Poli T, Silini EM, Sesenna E, Dolivet G, Mastronicola R, Leroux A, Sassoon I, Sloan P, McGurk M. Sentinel European Node Trial (SENT): 3-year results of sentinel node biopsy in oral cancer. Eur J Cancer. 2015 Dec;51(18):2777-84. doi: 10.1016/j.ejca.2015.08.023. Epub 2015 Nov 18.
Results Reference
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PubMed Identifier
33052754
Citation
Garrel R, Poissonnet G, Moya Plana A, Fakhry N, Dolivet G, Lallemant B, Sarini J, Vergez S, Guelfucci B, Choussy O, Bastit V, Richard F, Costes V, Landais P, Perriard F, Daures JP, de Verbizier D, Favier V, de Boutray M. Equivalence Randomized Trial to Compare Treatment on the Basis of Sentinel Node Biopsy Versus Neck Node Dissection in Operable T1-T2N0 Oral and Oropharyngeal Cancer. J Clin Oncol. 2020 Dec 1;38(34):4010-4018. doi: 10.1200/JCO.20.01661. Epub 2020 Oct 14.
Results Reference
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PubMed Identifier
33877855
Citation
Hasegawa Y, Tsukahara K, Yoshimoto S, Miura K, Yokoyama J, Hirano S, Uemura H, Sugasawa M, Yoshizaki T, Homma A, Chikamatsu K, Suzuki M, Shiotani A, Matsuzuka T, Kohno N, Miyazaki M, Oze I, Matsuo K, Kosuda S, Yatabe Y; HNCMM Research Group. Neck Dissections Based on Sentinel Lymph Node Navigation Versus Elective Neck Dissections in Early Oral Cancers: A Randomized, Multicenter, and Noninferiority Trial. J Clin Oncol. 2021 Jun 20;39(18):2025-2036. doi: 10.1200/JCO.20.03637. Epub 2021 Apr 20.
Results Reference
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PubMed Identifier
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Citation
Vaish R, Mittal N, Mahajan A, Rane SU, Agrawal A, D'Cruz AK. Sentinel node biopsy in node negative early oral cancers: Solution to the conundrum! Oral Oncol. 2022 Nov;134:106070. doi: 10.1016/j.oraloncology.2022.106070. Epub 2022 Aug 18.
Results Reference
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Citation
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Results Reference
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Sentinel Node Biopsy in Early Oral Cancers a Tertiary Cancer Centre Experience

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