| CTRI Number |
CTRI/2024/02/062655 [Registered on: 14/02/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
CASE SERIES |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate effect of immunotherapy . |
|
Scientific Title of Study
|
To evaluate effect of immunotherapy on clinical parameters using PET CT Scan in patients diagnosed with metastatic or recurrent unresectable head and neck cancer-a retrospective observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SO-01,Version 1.0,Dated 06/Dec/2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nidhi Hari |
| Designation |
FELLOW |
| Affiliation |
HCG-NCHRI Cancer Centre |
| Address |
Room Number 1, Ground Floor
Department Of Surgical Oncology, HCG NCHRI Cancer Centre, Khasra No. 50,51
Mouja Wanjri, Bande Nawaz Nagar, Near Automative Square
Kalamna Ring Road,
Nagpur
Nagpur MAHARASHTRA 440026 India |
| Phone |
8197647491 |
| Fax |
|
| Email |
drnidhihariomfs@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nidhi Hari |
| Designation |
FELLOW |
| Affiliation |
HCG-NCHRI Cancer Centre |
| Address |
Room Number 1, Ground Floor
Department Of Surgical Oncology, HCG NCHRI Cancer Centre, Khasra No. 50,51
Mouja Wanjri, Bande Nawaz Nagar, Near Automative Square
Kalamna Ring Road,
Nagpur
Nagpur MAHARASHTRA 440026 India |
| Phone |
8197647491 |
| Fax |
|
| Email |
drnidhihariomfs@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Nidhi Hari |
| Designation |
FELLOW |
| Affiliation |
HCG-NCHRI Cancer Centre |
| Address |
Room Number 1, Ground Floor
Department Of Surgical Oncology, HCG NCHRI Cancer Centre, Khasra No. 50,51
Mouja Wanjri, Bande Nawaz Nagar, Near Automative Square
Kalamna Ring Road,
Nagpur
Nagpur MAHARASHTRA 440026 India |
| Phone |
8197647491 |
| Fax |
|
| Email |
drnidhihariomfs@gmail.com |
|
|
Source of Monetary or Material Support
|
| HCG NCHRI CANCER CENTRE,NAGPUR |
|
|
Primary Sponsor
|
| Name |
HCG NCHRI Cancer Centre |
| Address |
HCG NCHRI CANCER CENTRE NAGPUR |
| 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 NIDHI HARI |
HCG-NCHRI CANCER CENTRE,NAGPUR |
Room Number 1, Ground Floor
Department Of Surgical Oncology, HCG NCHRI Cancer Centre, Khasra No. 50,51
Mouja Wanjri, Bande Nawaz Nagar, Near Automative Square
Kalamna Ring Road,
Nagpur
Nagpur MAHARASHTRA |
8197647491
drnidhihariomfs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HCG NCHRI CANCER CENTRE INSTITUTIONAL ETHICS CIMMITTEE |
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 |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Recurrent and Metastatic head and neck cancer patients who received Immunotherapy from September 2022 to September 2023 |
|
| ExclusionCriteria |
| Details |
study does not have exclusion criteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to measure overall survival rate, duration of response and progression free survival |
After starting immunotherapy, every three weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NOT APPLICABLE |
NOT APPLICABLE |
|
|
Target Sample Size
|
Total Sample Size="10" Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/02/2024 |
| Date of Study Completion (India) |
20/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Head and Neck cancers accounts for the sixth most common cancer worldwide with 8 lakh new cancer cases and 4.5 lakhs deaths worldwide.50-60%patients treated for HNC have a tendency for loco-regional recurrence within 2 years and 20-30% patients develop distant metastasis. despite the development in chemotherapy targeted radiotherapy and surgery the estimated survival of HNSCC remains approximately 50%. For second line treatment options for patients refractory to platinum based chemotherapy cetuximab/taxanes/methotrexate has become the standard therapy with recurrent and or metastatic local disease,resulting in progression free survival of only 2-3 months with a response rate of 4-14%. for patients who develop unresectable or metastatic recurrence systemic therapy depends upon platinum sensitivity as well as biological factord such as PDL1 receptor status .Sytemic therapy includes platinum based chemotherapy combination with or without Immune check point inhibitors. Tumour cells assume particular characteristics that allow them to evade the immune system by activating co-inhibitory pathways ,thereby inducing immune tolerance and tumour progression the use of anti-PD-1/PD-L1 has shown to restore T-cell mediated anti-tumour immunity Pembrolimuzumab and Nivolumabv have been approved for patients with metastatic,recurrent and unresectable HNSCC
We evaluate the OVERALL RESPONSE RATE,DURATION OF RESPONSE AND PROGRESSION FREE SURVIVAL using PET-CT Scan of patients who are undergoing Immunotherapy |