| CTRI Number |
CTRI/2023/07/055558 [Registered on: 24/07/2023] Trial Registered Prospectively |
| Last Modified On: |
01/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Real World data collection |
| Study Design |
Other |
|
Public Title of Study
|
Real World Data Collection of Nimotuzumab in Cisplatin ineligible Locally Advanced Head & Neck Cancer |
|
Scientific Title of Study
|
An Observational Real World Data Collection to Assess Effectiveness & Safety of Nimotuzumab in Cisplatin ineligible Locally Advanced Head and Neck Cancer |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akhil Kapoor |
| Designation |
Associate Professor |
| Affiliation |
Mahamana Pandit Madan Mohan Malaviya Cancer Center |
| Address |
Mahamana Pandit Madan Mohan Malaviya Cancer Center ,BHU Campus , Sunder Bagiya , Sunderpur , Varanasi UP -221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7597364554 |
| Fax |
|
| Email |
kapoorakhil1987@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neera Gupta |
| Designation |
Senior Director |
| Affiliation |
Biocon Biologics Limited |
| Address |
Biocon Biologics Limited
Biocon House, Semicon Park
Electronics City, Phase – II, Hosur Road
Bengaluru 560100, Karnataka, India
Bangalore
KARNATAKA
560100
India |
| Phone |
9986433312 |
| Fax |
|
| Email |
neera.gupta101@biocon.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Yashwant Jadhav |
| Designation |
Associate Manager |
| Affiliation |
Biocon Biologics Limited |
| Address |
Biocon Biologics Limited
Biocon House, Semicon Park
Electronics City, Phase – II, Hosur Road
Bengaluru 560100, Karnataka, India
Bangalore
KARNATAKA
560100
India |
| Phone |
8177835253 |
| Fax |
|
| Email |
amit.jadhav@biocon.com |
|
|
Source of Monetary or Material Support
|
| Biocon Biologics Limited
Biocon Biologics Limited
Biocon House, Semicon Park
Electronics City, Phase – II, Hosur Road
Bengaluru 560100, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Biocon Biologics Limited |
| Address |
Biocon Biologics Limited
Biocon House, Semicon Park
Electronics City, Phase – II, Hosur Road
Bengaluru 560100, Karnataka, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Akhil Kapoor |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre |
Department of Medical Oncology Mahamana Pandit Madan Mohan Malaviya Cancer Centre Sundar Bagiya Near Nariya Gate
Banaras Hindu University Campus
Varanasi (U.P.) 221005 India
Varanasi
UTTAR PRADESH |
7597364554
kapoorakhil1987@gmail.com |
| Dr A K Vaid |
Medanta Cancer Institute |
Department of Medical Oncology Medanta Cancer Institute Medanta The Medicity CH Baktawar Singh Road Sector 38 Gurugram Haryana 122001
Gurgaon
HARYANA |
9810212235
akvaid@yahoo.com |
| Dr N K Warrier |
MVR Cancer Centre and Research Institute |
Department of Medical Oncology MVR Cancer Centre and Research Institute Cp 13 516 B C Vellalasseri Nit(Via)
Poolacode Kozhikode Kerala 673601
Kozhikode
KERALA |
9495617585
enkwarrier@gmail.com |
| Dr Chandrakanth M V |
NARAYANA SUPERSPECIALITY HOSPITAL |
Department of Medical Oncology NARAYANA SUPERSPECIALITY HOSPITAL 120/1, ANDUL ROAD, NEAR NABANNA,
HOWRAH-711103
Kolkata
WEST BENGAL |
7738519198
drmvch@gmail.com |
| Dr B V Ravishankar |
Omega Cancer Hospitals Cancer Treatment Hospital |
Department of Medical Oncology Omega Cancer Hospitals Cancer Treatment Hospital Chinna Gadhili Hanumanthavaka Visakhapatnam Andhra Pradesh 530040
Visakhapatnam
ANDHRA PRADESH |
9849123256
ravi_bellala@yahoo.co.in |
| Dr Rajat Saha |
Rajiv Gandhi Cancer Institute & Research Centre |
Department of Medical Oncology Rajiv Gandhi Cancer Institute & Research Centre Sir Chotu Ram Marg Sector 5 Rohini Institutional Area Rohini New Delhi Delhi 110085 India
New Delhi
DELHI |
9350220257
drrajatsaha78@gmail.com |
| Dr Ghanashyam Biswas |
Sparsh-AOI |
Department of Medical Oncology Sparsh-AOI At Sparsh Hospitals and Critical Care, A/407, Sahid Nagar, Bhubaneswar, Odisha 751007
Cuttack
ORISSA |
9937500878
drgbiswas@gmail.com |
| Dr Vanita Noronha |
Tata Memorial Hospital |
Department of Medical Oncology TATA MEMORIAL CENTRE, Tata Memorial Hospital (TMH) and
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) at
Dr. E. Borges Road, Parel, Mumbai- 400 012
Mumbai
MAHARASHTRA |
9769328047
vanita.noronha@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Tata Memorial Hospital Mumbai |
Submittted/Under Review |
| Medanta Institutional Ethics Committee (MIEC) |
Submittted/Under Review |
| MPMMCC Varanasi |
Submittted/Under Review |
| MVR Cancer Centre and Research Institute |
Approved |
| NSH Ethics Committee |
Approved |
| Omega Cancer Hospitals Cancer Treatment Hospital |
Approved |
| RGCIRC |
Approved |
| Sparsh Hospitals and Critical Care Private Limited |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C109||Malignant neoplasm of oropharynx,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Histologically and cytologically confirmed diagnosis of locally advanced head and neck squamous cell carcinoma (LAHNSCC)
Adults of either sex, between 18 years or above who have been prescribed Nimotuzumab in routine clinical practice
Patients with Renal dysfunction, Hearing impairment, Neuropathy, or patients unfit for cisplatin therapy as per physician’s discretion
Patients with Marrow, Respiratory, Cardiovascular, and Hepatic dysfunctions
|
|
| ExclusionCriteria |
| Details |
Patients will not be eligible if known or suspected hypersensitivity to compounds with similarity to Nimotuzumab or Pregnant or lactating women or Patients who decline consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Overall response rate |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Overall response rate |
12 months |
| Disease control rate |
12 months |
| Progression-free survival |
12 months |
| Overall Survival |
12 months |
| Impact of assessment of personalized cancer care on quality of life using FACT-HN Score |
6 months |
| Frequency, incidence, & severity of adverse events (AEs) |
6 & 12 months |
FACT-HN
|
0 months & 6 months |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
01/08/2023 |
| 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="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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 - NO
|
Brief Summary
Modification(s)
|
Many patients may be ineligible for cisplatin due to age or medical comorbidities, develop intolerance necessitating treatment breaks, or survive with chronic adverse effects. Considering the increased rates of significant adverse effects of concurrent chemotherapy and radiation therapy (CRT), the MACH-NC study found a decreasing benefit of systemic therapy with increasing age. Efficacy and tolerability of nimotuzumab plus Chemotherapy (Carboplatin/docetaxel/5FU) plus RT or Nimotuzumab plus RT in patients with LAHNSCC who are ineligible for cisplatin treatment have limited evidence in Indian settings. So, we aimed this real-world observational data collection, prospectively, to observe clinical outcomes and safety of "Nimotuzumab plus RT, or Nimotuzumab plus Chemotherapy (Carboplatin/docetaxel/5FU) plus RT" in patients with LAHNSCC who are ineligible for cisplatin treatment. Also, the impact of personalized cancer care on patients’ quality of life will be evaluated. |