Study to Determine the Treatment Patterns and Outcomes in Patients With Resectable Early-stage (IA to IIIB) Non-small Cell LungCancer
Completed
- Conditions
- Malignant neoplasm of unspecifiedpart of bronchus or lung,
- Registration Number
- CTRI/2021/11/037936
- Lead Sponsor
- AstraZeneca Pharma India Ltd
- Brief Summary
To describe the treatment patterns and determine their associated 3-year survival outcome according to clinical and pathologic staging in patients with resectable early-stage (IA to IIIB) (as per American Joint Committee on Cancer [AJCC] seventh edition) NSCLC
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
- Adult female and male patients aged ≥18 years or adults according to age of majority as defined by the local regulations on index date 2.
- Patient or next of kin/legal representative (for deceased patients at study entry unless a waiver is granted) willing and able to provide written or electronic informed consent according to the local regulations, where applicable 3.
- Patients diagnosed with primary stage IA to IIIB NSCLC as per seventh edition AJCC whose tumour was deemed resectable between 01 January 2013 and 31 December 2017 and followed up until at least 31 December 2020 as per the medical records with availability of at least 12 months of follow-up data from the index date (date of diagnosis of early-stage [IA to stage IIIB] resectable NSCLC) unless patient died within 12 months of diagnosis.
Exclusion Criteria
- 1.Patients with a concomitant cancer at the time of diagnosis of NSCLC, except for nonmetastatic nonmelanoma skin cancers, or in situ or benign neoplasms; a cancer will be considered concomitant if it occurs within 5 years of NSCLC diagnosis 2.
- Patients diagnosed with stage IV NSCLC 3.
- Histology of the tumour is small cell lung cancer, neuroendocrine in origin, or a mixed histologic type with small cell and non-small cell lung cancers.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Proportion of patients overall and as per clinical and pathologic staging (seventh edition of the tumour nodes metastases [TNM] classification for lung cancer [AJCC]) who underwent either of the following treatment modalities: one-time o Surgery only one-time o Neo-adjuvant therapy (chemo+/-radiotherapy) only one-time o Adjuvant therapy (chemo+/-radiotherapy) only one-time o Neo-adjuvant and adjuvant therapies one-time 2. Duration of treatment for each treatment regimen in neo-adjuvant and adjuvant treatment settings, dose of each agent, and reason(s) for stopping treatment in each setting one-time 3. 3-year survival rate (overall, and as per clinical and pathologic staging) defined as percentage of patients confirmed to be alive at 3 years from the index date. one-time
- Secondary Outcome Measures
Name Time Method Demographic and clinical-pathological characteristics (overall and as per treatment modalities) Survival outcomes
Trial Locations
- Locations (8)
Asian Cancer Institute - Cumbala Hill Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Asian Institute of Medical Sciences
🇮🇳Faridabad, HARYANA, India
Dr. B.L. Kapur Memorial Hospital
🇮🇳Delhi, DELHI, India
Manipal Comprehensive Cancer Centre
🇮🇳Bangalore, KARNATAKA, India
Max Super Speciality Hospital
🇮🇳Delhi, DELHI, India
Narayana Superspeciality Hospital
🇮🇳Kolkata, WEST BENGAL, India
TATA Medical Center
🇮🇳Kolkata, WEST BENGAL, India
Tata Memorial Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Asian Cancer Institute - Cumbala Hill Hospital🇮🇳Mumbai, MAHARASHTRA, IndiaDr Ramakant DeshpandePrincipal investigator9820422222ramandeshpande@gmail.com