| CTRI Number |
CTRI/2021/11/037936 [Registered on: 11/11/2021] Trial Registered Prospectively |
| Last Modified On: |
15/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective study |
| Study Design |
Other |
|
Public Title of Study
|
Study to Determine the Treatment Patterns and Outcomes in Patients With Resectable Early-stage (IA to IIIB) Non-small Cell Lung
Cancer |
|
Scientific Title of Study
|
A Multicountry, Multicentre, Non-interventional, Retrospective Study to
Determine the Real-world Treatment Patterns and Associated Outcomes in
Patients With Resectable Early-stage (IA to IIIB) Non-small Cell Lung
Cancer |
| Trial Acronym |
THASSOS-International |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D133FR00169 Version 2.0 Dated 13 Aug 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Somashekhar S |
| Designation |
Consultant Surgical Oncologist |
| Affiliation |
Manipal Comprehensive Cancer Centre Manipal Hospital Bangalore |
| Address |
Manipal Comprehensive Cancer Centre Manipal Hospitals #98 Rustom Bagh Airport Road Bengaluru-560017 Karnataka
Manipal Comprehensive Cancer Centre Manipal Hospitals #98 Rustom Bagh Airport Road Bengaluru-560017 Karnataka
Bangalore
KARNATAKA
560017
India |
| Phone |
|
| Fax |
|
| Email |
somusp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankush Gaikwad |
| Designation |
Medical Affairs Manager |
| Affiliation |
AstraZeneca Pharma India Ltd |
| Address |
AstraZeneca Pharma India Ltd Block N1 12th Floor
ManyataEmbassy Business Park Rachenahalli Outer Ring Road
Bangalore 560045
Bangalore
KARNATAKA
560045
India |
| Phone |
|
| Fax |
|
| Email |
ankush.vikasgaikwad@astrazeneca.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Amit Kumar |
| Designation |
Project Delivery Lead |
| Affiliation |
AstraZeneca Pharma India Ltd |
| Address |
AstraZeneca Pharma India Ltd Block N1 12th Floor
ManyataEmbassy Business Park Rachenahalli Outer Ring Road
Bangalore 560045
Bangalore
KARNATAKA
560045
India |
| Phone |
|
| Fax |
|
| Email |
Amit.KumarAK@astrazeneca.com |
|
|
Source of Monetary or Material Support
|
| AstraZeneca Pharma India Ltd |
|
|
Primary Sponsor
|
| Name |
AstraZeneca Pharma India Ltd |
| Address |
AstraZeneca Pharma India Ltd Block N1 12th Floor Manyata Embassy Business Park Rachenahalli Outer Ring Road Bangalore-560045 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Australia
Brazil
Egypt
Hong Kong
India
Kuwait
Qatar
Saudi Arabia
Turkey
United Arab Emirates |
Sites of Study
Modification(s)
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramakant Deshpande |
Asian Cancer Institute - Cumbala Hill Hospital |
ACI-Cumbala Hill Hospital, 93/95, August Kranti Marg, Kemps corner, Mumbai - 400036
Mumbai
MAHARASHTRA |
9820422222
ramandeshpande@gmail.com |
| Dr Praveen Bansal |
Asian Institute of Medical Sciences |
Asian Institute of Medical Sciences,
Badkal Flyover, Sector - 21A,
Faridabad, Haryana - 121001
Faridabad
HARYANA |
9971635572
drpraveenkb@yahoo.com |
| Dr Sajjan Rajputohit |
Dr. B.L. Kapur Memorial Hospital |
Dr. B.L. Kapur Memorial Hospital
Pusa Rd, Radha Soami Satsang, Rajendra Place, New Delhi, Delhi 110005
New Delhi
DELHI |
9999660200
sajjanrajpurohit@yahoo.com |
| Dr Amit Rauthan |
Manipal Comprehensive Cancer Centre |
Manipal Comprehensive Cancer Centre, Manipal Hospitals,#98, Rustom Bagh, Airport Road Bangalore-560017,Karnataka
Bangalore
KARNATAKA |
9880463958
amitrauthan@yahoo.com |
| Dr Devavrat Arya |
Max Super Speciality Hospital |
Max Super Speciality Hospital (A Unit Of Devki Devi Foundation), East Block, 2, Press Enclave Road, Saket, New Delhi-110017
New Delhi
DELHI |
9711400908
devavrat200@gmail.com |
| Dr Vivek Agarwala |
Narayana Superspeciality Hospital |
Narayana Superspeciality Hospital
120/1, Andul Road, Near Nabanna, Shibpur, Howrah- 711103, Kolkata, WEST BENGAL
Kolkata
WEST BENGAL |
8879222875
drvivekagarwala@gmail.com |
| Dr Bivas Biswas |
TATA Medical Center |
TATA Medical Center, 14 Mar (EW), Newtown, Rajarhat, Kolkatta - 700160
Kolkata
WEST BENGAL |
9830922005
bivas.biswas@tmckolkatta.com |
| Dr Vijay Patil |
Tata Memorial Hospital |
Tata Memorial Hospital,Dr. E Borges Road,Parel-400012,Mumbai Maharashtra
Mumbai
MAHARASHTRA |
9136129135
vijaypgi@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| "Asian Institute of Oncology Pvt.Ltd, Institutional Ethics Committee " |
Approved |
| Dr. B. L. Kapur Memorial Hospital Ethics Committee |
Approved |
| Ethics committee of Manipal Hospitals |
Approved |
| Institution Review Board, Tata Medical Center |
Approved |
| Institutional Ethics Committee Devki Devi Foundation |
Approved |
| Institutional Ethics Committee, Tata Memorial Hospital |
Approved |
| Institutional Ethics Committee-Asian Institute of Medical Sciences |
Approved |
| NSH Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. 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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
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:
o Surgery only
o Neo-adjuvant therapy (chemo+/-radiotherapy) only
o Adjuvant therapy (chemo+/-radiotherapy) only
o Neo-adjuvant and adjuvant therapies
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
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
|
| Outcome |
TimePoints |
Demographic and clinical-pathological characteristics (overall and as per treatment modalities)
Survival outcomes
Prevalence of EGFR mutations and PD-L1 expression
Real-world OS within the following subgroups:
o Age (60 years, ≥60 to 80 years, and ≥80 years)
o Clinico-pathologic stage of NSCLC as per seventh edition AJCC (IA, IB, IIA, IIB, IIIA, IIIB) with lymph node metastasis status (N0, N1, and N2)
o EGFR mutation status (positive/negative)
o PD-L1 status (1%, ≥1% to 25%, ≥25% to 50%, and ≥50%)
Proportion of patients biomarker testing strategies
Proportion of patients receiving neo-adjuvant and/or adjuvant treatments
Proportion of patients undergoing each type of surgery and associated outcomes
Compliance to neo-adjuvant and/adjuvant treatment |
one-time |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
15/12/2021 |
| Date of Study Completion (India) |
31/01/2024 |
| Date of First Enrollment (Global) |
03/11/2021 |
| Date of Study Completion (Global) |
31/01/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 |