B.L. Kapur Memorial Hospital (A unit of Lahore Hospital Society)
Clinical Research Unit -II Academic Affairs Research and Continuing Education, Medical Oncology Department, Pusa Rd, New Delhi,
Delhi, 110005
New Delhi DELHI
9958450124
drchandragoudetrials@gmail.com
Dr Rakesh Pinninti
Basavatarakam Indo American Cancer Hospital & Research Institute
Medical Oncology Department, Room no 118, Block 1, First floor, Road No 10, Banjara Hills Hyderabad, Telangana, India 500034 Hyderabad TELANGANA
7021538508
pinninti.rakesh@gmail.com
Dr Bipinesh Sansar
Mahamana Pandit Madan Mohan Malviya Cancer Centre
Consultation room, Ground floor, Oncology division, Dept of Medical Oncology, MPMMCC, Banaras Hindu University, Campus, Sundar Bagiya Colony, Sundarpur, Varanasi, Uttar Pradesh 221005 Varanasi UTTAR PRADESH
8002583913
bipinesh04@yahoo.co.in
Dr Rohit Nayyar
Max Super Speciality Hospital, Saket (A Unit of Devki Devi Foundation)
1st Floor, Oncology division, Medical Oncology Department.
2, Press Enclave Road, Saket, New Delhi- 110017
South DELHI
9810757607
Rohit.Nayyar@maxhealthcare.com
Dr Sajeevan K V
MVR Cancer Centre & Research Centre
Room no. 10, Ground floor, Oncology division, Department of medical oncology, MVR Cancer Centre and Research Institute, CP 13/516 B.C. Vellalasseri, REC (via) Poolacode, Kozhikode, Kerala-673601 Kozhikode KERALA
9496126713
drsajeevan@mvrccri.co
Dr Chandrakanth MV
Narayana Super Speciality Hospital
Room No 18, Oncology division, Department of Medical Oncology, Ground floor, 120/1, Andul Road, Howrah-711103, West Bengal, India Haora WEST BENGAL
7738519198
drmvch@gmail.com
Dr Vijay Patil
SUNACT Cancer Institute Pvt.Ltd
Consultation room, 4th floor, Tieten Medicity Hospital, Oncology division, Department of Medical Oncology, Ghodbunder Rd, Kasarvadavali, Thane West, Thane, Maharashtra 400615
Thane MAHARASHTRA
9136129135
vijaypgi@gmail.com
Dr Kumar Prabhash
Tata Memorial Hospital
Room No 204, Oncology division, Dept of medical Oncology 2nd floor, Homi Bhabha Block Tata Memorial Hospital Dr E Borges Road Parel Dr E Borges Road Parel (east) Mumbai MAHARASHTRA 400012 India Mumbai (Suburban) MAHARASHTRA
Basavatarakam Indo American Cancer Hospital & Research Institute Institutional Ethics Committee
Approved
Dr B L Kapur Memorial Hospital Ethics Committee
Approved
IEC, MPMMCC and HBCH Varanasi Mahamana Pandit Madan Mohan Malaviya Cancer Centre
Approved
Institutional Ethics Committee
Approved
Institutional Ethics Committee
Approved
Institutional Ethics Committee, Devki Devi Foundation
Approved
NSH Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Notified
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
Nil
Nil
Comparator Agent
Nil
Nil
Intervention
Nil
Nil
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1.Patients aged greater than or equal to 18 years of age at the time of LA HNSCC diagnosis.
2.Patients of either sex with histopathological confirmed diagnosis (biopsy-proven) of HNSCC involving all types of oral cancers (including lip & oral, base of tongue and others), laryngeal, oropharyngeal, and hypopharyngeal cancers.
3.Patients diagnosed with LA HNSCC (Stage III to Stage IVB lip & oral, HPV negative laryngeal, oropharyngeal, and hypopharyngeal cancers or Stage III HPV positive HNSCC (excluding nasopharyngeal cancers) between January 01, 2018, and December 31, 2022 (patient identification period).
4.Patients prescribed with first therapy for the treatment of treatment naïve LA HNSCC.
5.Patients with availability of minimum one year follow-up data post initiation of first therapy for LA HNSCC management
6.Patients with greater than or equal to 5 visits at the selected sites for enrollment.
ExclusionCriteria
Details
1.Patient with nasopharyngeal cancers of any etiology.
2.Patients with malignancies involving paranasal sinuses, salivary glands, or thyroid.
3.Patient who has participated in any interventional clinical trials, for the management of LA HNSCC during the study period.
4.Patients who did not receive any definitive treatment after diagnosis due to refusal of treatment plan.
5.Patients with malignant diseases other than LA HNSCC, diagnosed within 5 years prior to the diagnosis of LA HNSCC.
6.Patients who received treatment indicated for another primary cancer between January 01,2018 and December 31, 2022.
7.Patients who received immune checkpoint inhibitors for LA HNSCC disease.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Distribution of 1st treatments
- Time from initial LA HNSCC diagnosis to 1st treatment initiation
- Percentage of patients treated with next treatment
- Surgery rate
- Percentage of patients with induction chemotherapy, induction drugs used, schemes of induction drugs
-Percentage of patients with neoadjuvant chemotherapy, neoadjuvant drugs used, schemes of neoadjuvant drugs
-Percentage of patients with concurrent pharmacological treatment, concurrent drugs used, schemes of concurrent drugs
-Percentage of patients in each of the different treatment sequences found
From site initiation to end of follow up (approximately 2 years)
Secondary Outcome
Outcome
TimePoints
-Proportion of patients being tested for HPV status, proportion of patients positive for HPV
-Proportion of patients being tested for PD-L1 status, proportion of patients positive for PD-L1
-Percentage of cases evaluated in tumor board
From site initiation to end of follow up (approximately 2 years)
Target Sample Size
Total Sample Size="500" Sample Size from India="500" Final Enrollment numbers achieved (Total)= "500" Final Enrollment numbers achieved (India)="500"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Rationale:
Among the therapies for locally advanced head and neck squamous cell carcinoma (LA HNSCC), surgery is the mainstay of management, and there are differences between Indian management and JCAP (Japan, China & Asia-Pacific) practices for the same especially with respect to surgeries and the use of newer modalities. This study will help us understand the lacunae in the treatment management patterns, which can be addressed using newer regimens, thereby effectively improving patient care experience.
Primary Objective:
To understand the management of patients diagnosed with LA HNSCC, in terms of:
o Patient profile, clinical, tumor, and provider characteristics, treatment patterns (including sequencing), among patients diagnosed with locally advanced head and neck squamous cell carcinoma (LA HNSCC) [overall], in a cohort of patients [deemed operable] and in a cohort of patients [deemed inoperable].
o Clinical outcomes – Real-world Time to Treatment, Time of Treatment Discontinuation, and Time to Next Treatment for LA HNSCC treatments in sequence and additional outcomes based on datasets captured.
Study Design:
This is a retrospective non-interventional observational study to evaluate patient profiles, treatment patterns, and clinical characteristics among patients diagnosed with LA HNSCC between January 01, 2018 and December 31, 2022. Patients who meet the study eligibility criteria will be followed longitudinally until the date of first treatment with palliative intent OR the date of diagnosis of metastatic HNSCC OR the date of last patient record OR the date of end of study period, whichever occurs first. Maximum follow-up data of these patients will be collected until December 31, 2024
Study Population:
The study population will consist of patients diagnosed with LA HNSCC (Stage III to Stage IVB per AJCC [American Joint Committee on Cancer] 8th edition), between January 01, 2018, and December 31, 2022, with follow-up until December 31, 2024. Sample size for the study would be 500 patients.