| CTRI Number |
CTRI/2024/10/075043 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
09/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Does oral cancer spread to opposite side of neck in advanced stage |
|
Scientific Title of Study
|
Incidence of contralateral neck node metastasis in locally advanced, resectable, lateralized oral squamous cell carcinoma—a prospective interventional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jino JL |
| Designation |
Senior Resident |
| Affiliation |
Christian Medical College and Hospital, Vellore |
| Address |
Room No. 1204, Second Floor, Paul brand building, Christian Medical College, Vellore, Tamil Nadu
IDA Scudder Rd, Vellore, Vellore, Tamil Nadu 632004, India
Vellore
TAMIL NADU
632004
India |
| Phone |
9483950065 |
| Fax |
|
| Email |
jinolalith93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Konduru Vidya |
| Designation |
Associate Professor |
| Affiliation |
Christian medical college and hospital |
| Address |
Room No. 1204, Second Floor, Paul brand building, Christian Medical College, Vellore, Tamil Nadu
IDA Scudder Rd, Vellore, Vellore, Tamil Nadu 632004, India
Vellore
TAMIL NADU
632004
India |
| Phone |
9585222696 |
| Fax |
|
| Email |
vidya5feb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jino JL |
| Designation |
Senior Resident |
| Affiliation |
Christian Medical College and Hospital, Vellore |
| Address |
Room No. 1204, Second Floor, Paul brand building, Christian Medical College, Vellore, Tamil Nadu
IDA Scudder Rd, Vellore, Vellore, Tamil Nadu 632004, India
Vellore
TAMIL NADU
632004
India |
| Phone |
9483950065 |
| Fax |
|
| Email |
jinolalith93@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of head and neck surgery unit-2,Room No. 1204, Paul brand building, Christian Medical College, Vellore, IDA Scudder Rd, Vellore, Vellore, Tamil Nadu 632004, India |
|
|
Primary Sponsor
|
| Name |
Dr.Jino JL |
| Address |
Room No. 1204, Second Floor, Paulbrand Building, Christian Medical College, Vellore, Tamil Nadu, India. |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jino JL |
Christian Medical College Vellore |
Room. No -1204, Second floor, Paul brand building, Department of Head and Neck Surgery, Unit - 2, Christian Medical College, Vellore, Ida Scudder Road, Vellore-632004, Tamil Nadu, India.
Vellore
TAMIL NADU |
9791087808
jinolalith93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, Christian Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Contralateral neck dissection (levels 1b and 2a) |
In patients undergoing surgery for oral cancers from November 01,2024 till October 31 2026, those who fit the inclusion criteria will be subjected to contralateral neck dissection (which involves levels 1b and 2a) in a single setting when the primary surgery is done. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1) Resectable, locally advanced oral SCC (AJCC 8th Edition TNM Stage IVA and IVB), which does not involve or cross the midline—clinical tumor stage T4a or T4b disease in the gingivobuccal complex and T3 tumors of the tongue and floor of the mouth.
2) Ipsilateral nodal involvement with extra-nodal extension (N3b)
3) Biopsy: Poorly differentiated tumor grade
4) No clinical or radiological evidence of contralateral nodal metastasis
|
|
| ExclusionCriteria |
| Details |
1) Past history of treatment for head and neck cancer
2) Borderline resectable, unresectable, inoperable or metastatic disease at presentation
3) Clinical or radiological evidence of contralateral nodal metastasis
4) Recurrent oral cancer planned for salvage surgery
5) Tumor involving or crossing the midline
6) T1, T2 disease
7) Multiple or synchronous primary tumors in the head and neck
8) Under 18 years of age or over 90 years of age, or who are pregnant or otherwise vulnerable
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of contralateral nodal metastasis in histopathological specimen |
Post surgery, second week - when the histopathological report comes, Post surgery follow-up at 3months, 6months. 9 months and one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To correlate the incidence of contralateral nodal metastasis with other clinicopathological adverse prognostic factors in oral squamous cell carcinoma.
2)To develop a statistical model incorporating predictive factors for contralateral nodal metastasis to guide the need for contralateral neck dissection for oral squamous cell carcinoma.
|
Post operative period |
| Contralateral nodal recurrence rate |
one year |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [jinolalith93@gmail.com].
- For how long will this data be available start date provided 07-05-2027 and end date provided 07-05-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The incidence of contralateral lymph node
metastasis in lateralized oral cancer varies from 0.9% to 36% in previous
studies. However, in those studies, the data is heterogeneous; most of those studies have included patients with
midline disease, and many have included cases which have received treatment for
the contralateral neck. No conclusions have been derived which could change
management guidelines, except for identification of selected risk factors for
contralateral neck metastases, like tumor stage, grade, ipsilateral neck
metastases and extranodal extension. In this study, we propose to perform contralateral
elective, superselective neck dissection of levels 1b and 2a for patients with
locally advanced, resectable, lateralized OSCC not crossing the midline. We aim
to study the incidence of contralateral lymph node metastases and to correlate
this to other clinicopathological adverse prognostic factors of OSCC. We hope
to develop statistical models encompassing the factors predictive for
occurrence of such metastases and to form a rational basis for elective contralateral
neck management. |