Locally Advanced Head and Neck Treatment Patterns Evaluation through Retrospective medical Records in a Non interventional Study India

MSD Pharmaceuticals Pvt Ltd7 个研究点分布在 1 个国家目标入组 500 人开始时间: 2025年6月16日最近更新: 2025年5月29日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 500
试验地点: 7
主要终点: Distribution of 1st treatments

研究概览入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Observational

入排标准

年龄范围: 18.00 Year(s) 至 99.00 Year(s)（—）
性别: All

入选标准

•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.

排除标准

•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.
•7.Patients who received immune checkpoint inhibitors for LA HNSCC disease.