| CTRI Number |
CTRI/2024/06/069588 [Registered on: 27/06/2024] Trial Registered Prospectively |
| Last Modified On: |
26/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Impact of NACT on surgical decision and peri-operative outcome in patients with very advanced buccal cancer |
|
Scientific Title of Study
|
Impact of Neo adjuvant chemotherapy on surgical decision and peri-operative outcome in patients with very advanced buccal cancers |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akash Mishra |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of ENT
All India Institute of Medical Sciences, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9599312536 |
| Fax |
|
| Email |
akash39246@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Kapil Sikka |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of ENT
All India Institute of Medical Sciences, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9810423088 |
| Fax |
|
| Email |
kapil_sikka@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akash Mishra |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
ENT Department
All India Institute of Medical Sciences, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9599312536 |
| Fax |
|
| Email |
akash39246@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS, New Delhi |
| Address |
All India Institute of Medical Sciences, Ansari nagar , New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 AKASH MISHRA |
AIIMS, DELHI |
DEPARTMENT OF OTORHINOLARYNGOLOGY, ROOM NO 4057
New Delhi
DELHI |
9599312536
akash39246@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
. All patients age 18 years and above with the confirmed diagnosis of locally advanced non metastatic carcinoma- buccal mucosa who were deemed as borderline resectable on multi-disciplinary team discussion and received neo-adjuvant chemotherapy before definitive surgery from January 1 , 2019 to Feb 2023 at both the centres( retrospective study) .
2. For prospective part of study, all newly diagnosed locally advanced- non metastatic carcinoma buccal mucosa patients who will be fulfilling below mentioned criteria for borderline resectability will be included.
a. Gingivo- buccal complex cancers with extensive skin involvement.
b. Skin edema reaching upto the level of zygoma.
c. Lateral pterygoid muscle, temporalis insertion or retroantral fat involvement.
3. Performance status: 0-1
4. Medically fit for definitive surgery
|
|
| ExclusionCriteria |
| Details |
All patients with disease extension to infra-notch area and pterygo-maxillary fissure involvement will not be included in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Surgical conversion Rate
3. Clinical and radiological factors associated with operability and chemotherapy effectiveness:
4. To evaluate surgical margins in patients who received neo-adjuvant chemotherapy before surgery:
5. Surgical outcomes |
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Total Duration of hospital stay after surgery:
a. For calculation of number of days, day will be calculated from date of surgery to day of discharge.
2. Radiological assessment of tumor response post neo-adjuvant chemotherapy in prospectively involved patients:
a. Response will be assessed as per RECIST guidelines
|
3 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
08/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
08/07/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title: Impact of NACT on surgical decision and perioperative outcome in patient with very advance buccal cancer Objective: primary: 1.
Surgical conversion Rate:
2.
Data will be analysed to see how many patients who received
neo-adjuvant chemotherapy as a primary treatment undergo surgery. Clinical and
radiological data will also be recorded to identify the factors associated with
non-operability decisions. All patients with involvement of masticator space
will also be stratified as per classification system given by Mahajan et al.
and data will be recorded to see which category of patients undergoing surgery.
3.
Clinical and radiological factors associated with operability and
chemotherapy effectiveness:
a.
Patients undergoing surgery after neo-adjuvant will be identified and
clinical and radiological data will be recorded to see which subset of
populations respond better to chemotherapy. Data will also be recorded
regarding chemotherapy regimen used.
Clinical and radiological factors which will be recorded includes: skin
involvement, infratemporal fossa involvement, soft tissue swelling upto zygoma.
4.
To evaluate surgical margins in patients who received neo-adjuvant
chemotherapy before surgery:
a.
Data regarding surgical margins will be assessed from the pathological
reports. Surgical margins will be classified as free, close and involved.
5.
Surgical outcomes:
a.
Surgical outcomes will be recorded as per classification system given
by Clavein and Dindo secondary: 1. Total Duration of hospital
stay after surgery: a. For calculation of number of
days, day will be calculated from date of surgery to day of discharge. 2. Radiological assessment of
tumor response post neo-adjuvant chemotherapy in prospectively involved patients:
Response will be assessed as per RECIST guidelines To achieve my objectives: 1. Patients post NACT radiological imaging ill will compared with pre-NACT imaging. 2. Response will be assesed 3. Any complication occured will be assessed
|