| CTRI Number |
CTRI/2018/10/016221 [Registered on: 31/10/2018] Trial Registered Prospectively |
| Last Modified On: |
01/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to understand patient characteristics and treatment of stage III non-small-cell lung cancer patients |
|
Scientific Title of Study
|
A multi-country, multi-centre, observational, retrospective study to reveal
the patient characteristics, disease burden, treatment patterns and patient
journey of stage III non-small-cell lung cancer patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D133HR00004 Version 1.0, Date 24 August 2018 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kumar Prabhash |
| Designation |
National Coordinating Investigator |
| Affiliation |
Tata Memorial Centre,Mumbai |
| Address |
Tata Memorial Centre,
Dr E Borges Road,
Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9167760576 |
| Fax |
|
| Email |
kprabhash1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kirtan Bhatt |
| Designation |
Study Physician |
| Affiliation |
AstraZeneca Pharma India Ltd |
| Address |
Block N1 12th Floor Manyata Embassy Business Park Rachenahalli
Outer Ring Road
Bangalore
KARNATAKA
560045
India |
| Phone |
919886266442 |
| Fax |
|
| Email |
kirtan.bhatt@astrazeneca.com |
|
Details of Contact Person
Public Query
|
| Name |
Amit Kumar |
| Designation |
Project Delivery Lead |
| Affiliation |
AstraZeneca Pharma India Ltd |
| Address |
Block N1 12th Floor Manyata Embassy Business Park Rachenahalli
Outer Ring Road
Bangalore
KARNATAKA
560045
India |
| Phone |
9972365541 |
| Fax |
|
| Email |
amit.kumarak@astrazeneca.com |
|
|
Source of Monetary or Material Support
|
| AstraZeneca Pharma India Limited Block N1 12th Floor Manyata Embassy Business Park Rachenahalli
Outer Ring Road
Bangalore
KARNATAKA
560045
India |
|
|
Primary Sponsor
|
| Name |
AstraZeneca Pharma India Limited |
| Address |
Block N1 12th Floor Manyata Embassy Business Park Rachenahalli
Outer Ring Road Bangalore KARNATAKA 560045 India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Singapore
Indonesia
Australia
Egypt
India
Malaysia |
Sites of Study
Modification(s)
|
| No of Sites = 21 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr A K Anand |
Max Institute of Cancer Care |
2nd 26A Ring Rd Vikram Vihar Lajpat Nagar IV Lajpat Nagar 110024
New Delhi
DELHI |
9810398838
akanand@maxhealthcare.com |
| Dr Ajay Sharma |
Action Cancer Hospital |
A-4 Paschim Vihar, New Delhi - 110063
New Delhi
DELHI |
9999379838
ajaysharma04@rediffmail.com |
| Dr Prabhat Singh Malik |
All India Institute of Medical Science |
Dr B R Ambedkar Institute Rotary Censer Research Hospital Ansari Nagar Block C1 Ansari Nagar East-110029
New Delhi
DELHI |
968325318
drprabhatsm@gmail.com |
| Dr Rajnish V Nagarkar |
Curie Manavata Cancer Centre |
Opp Mahamarg Bus Stand Mumbai Naka
Nashik
MAHARASHTRA |
9823061929
drraj@manavatacancercentre.com |
| Dr Amit Aggarwal |
Dr. B L Kapur Hospital,Delhi |
Deparment Of Medical Oncology OPD-7 First Floor Pusa Road New Delhi-110005
New Delhi
DELHI |
9971611311
deepaliamit@hotmail.com |
| Dr Nirav Asarawala |
H M Patel Cancer Centre |
Gokal Nagar
Karamsad-388325
Anand
GUJARAT |
9825744593
asarawalanirav@gmail.com |
| Dr Shekar Patil |
HeathCare Global Enterprises Limited |
No 8 HCG Towers P Kalinga Rao Road Sampangi Ram Nagar 560027
Bangalore
KARNATAKA |
9341245961
spassociates6@gmail.com |
| Dr Sewanti Limaye |
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute |
Lokhandwala Complex Rd Mudran Press Colony Andheri West 400061
Mumbai
MAHARASHTRA |
9619607339
sewanti@yahoo.com |
| Dr Amit Rauthan |
Manipal Hospital |
Clinical Research Center, Ground Floor
98 HAL Airport Road 560017
Bangalore
KARNATAKA |
9880463958
amitrauthan@yahoo.com |
| Dr PK Jhulka |
Max Institute of Cancer Care |
2nd 26A Ring Rd Vikram Vihar Lajpat Nagar IV Lajpat Nagar 110024
New Delhi
DELHI |
9818825626
pkjulka18@hotmail.com |
| Dr Gautam Goyal |
Max Super Speciality Hospital |
Room No 143, Basement 2, Max Super Specialty Hospital, Phase 6, Sahibzada Ajit Singh Nagar,
Bathinda
PUNJAB |
8195849111
gautam3636@gmail.com |
| Dr Ranga Rao |
Max Super Speciality Hospital |
Shalimar Bagh
Max Super Speciality Hospita, C and D Block, Shalimar Place Site, Shalimar Bagh
New Delhi
DELHI |
9810297787
rangaraorr@gmail.com |
| Dr Chanchal Goswami |
Medica Superspecialty Hospital |
127 Mukundapur EM Bypass 700099
Kolkata
WEST BENGAL |
9830055035
drcgoswami@gmail.com |
| Dr Narayanankutty Warrier |
MVR Cancer Centre & Research Centre |
CP 13/516 B C
Vellalaserry NIT(via)
Poolacode
Choolur Kozhikode-673601
Kozhikode
KERALA |
9447154208
n_goray@rediffmail.com |
| Dr Ullas Batra |
Rajiv Gandhi Cancer Institute & Research Centre |
D 18, Sector V
Rohini New Delhi-110085
New Delhi
DELHI |
9911080001
ullasbatra@gmail.com |
| Dr Ranjan Mahapatra |
SIMS Hospital |
Next to Vadapalani Metro Station No1 Jawaharlal Nehru Salai 100 Feet Road Vadapalani 600026
Chennai
TAMIL NADU |
9840033512
realpv60@hotmail.com |
| Dr Gul Mohammad Bhat |
SKIMS Hospital |
Srinagar
Srinagar
JAMMU & KASHMIR |
9419023334
drgull81250@yahoo.com |
| Dr Ghanashwam Biswas |
sparsh hospitals and critical care |
bhubaneswar 751007
Khordha
ORISSA |
9937500878
drgbiswas@gmail.com |
| Dr S H Advani |
Sushrut Hospital |
365 Swastik Park Eastern Express Highway Chembur East
Ahmadabad
GUJARAT |
9821157706
shadvani2000@yahoo.com |
| Dr Moses Arun Singh |
Tata Medical Center |
14 Major Arterial Road( EW),
New Town
Kolkata
WEST BENGAL |
9007395797
moses.arunsingh@tmckolkata.com |
| Dr Kumar Prabhash |
Tata Memorial Center |
Department of Medical Oncology HBB Bock Room no 3043rd floor Dr E Borges road Parel
Mumbai
MAHARASHTRA |
9167760576
kprabhash1@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 19 |
| Name of Committee |
Approval Status |
| Action Cancer Hospital Ethics Committee |
Approved |
| Conscience Independent Ethics Committee (CIEC) |
Approved |
| Conscience Independent Etihics Committee (CIEC) |
Approved |
| Ethics committee of Manipal Hospitals |
Approved |
| HCG-Central Ethics Committee |
Approved |
| institutional Ethics Commitee AIIMS |
Approved |
| institutional Ethics Commitee Rajiv Gandhi Cancer Institute |
Approved |
| institutional Ethics Commitee Sparsh Hospital |
Approved |
| institutional Ethics Commitee Tata Medical Center |
Approved |
| institutional Ethics Commitee Tta Memorial Center |
Approved |
| Institutional Ethics Committee Dr. B.L Kapur Memorial Hospital |
Approved |
| Institutional Ethics Committee H M Patel Centre for Medical Care and Education |
Approved |
| Institutional Ethics Committee Max Super Speciality Hospital |
Approved |
| Institutional Ethics Committee Max Super Speciality Hospital |
Approved |
| Institutional Ethics Committee Max Super Speciality Hospital |
Approved |
| Institutional Ethics Committee Max Super Speciality Hospital |
Approved |
| Institutional Ethics Committee Sher-i-Kashmir Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee SIMS |
Approved |
| Manavata Clinical Research Institute Ehtics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C342||Malignant neoplasm of middle lobe,bronchus or lung, (2) ICD-10 Condition: C348||Malignant neoplasm of overlappingsites of bronchus and lung, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Provision of informed consent by the patient or next of kin/legal representative (for deceased patients at study entry, unless a waiver was granted), according to local regulations
2. Adult male or female (18 years old or according to age of majority as defined by local regulations)
3. First ever diagnosis of lung cancer (absence of previous diagnosis of lung cancer, including small cell lung cancer [SCLC] and NSCLC) in the patient’s medical records
4. Primary diagnosis of stage III NSCLC, confirmed by pathology, between 01 January 2013 and 31 December 2017
5. Available medical records at the participating site reflect at least 9 months of follow-up from the index date (unless patient died within the first 9 months of diagnosis) |
|
| ExclusionCriteria |
| Details |
1. Patients with a concomitant cancer at the time of diagnosis of stage III NSCLC, except for non-metastatic non-melanoma 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 initially diagnosed with stage I-II NSCLC who have progressed to stage III |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Overall survival (OS)
The length of time from stage
III NSCLC diagnosis (index
date) or time of therapy
initiation to death due to any
cause. |
9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Progression-free survival
(PFS)The length of time from time of
therapy initiation to
documented disease
progression (as available in
the medical record) or death
due to any cause, whichever
occurs first. |
9 months |
|
|
Target Sample Size
|
Total Sample Size="2000"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="494" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/11/2018 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
30/11/2018 |
| Date of Study Completion (Global) |
Date Missing |
|
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
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This large multinational, non-interventional study (NIS), will retrospectively collect data derived from established medical records over a period of up to approximately 6 years (2013 to 2018), building a platform to capture and consolidate information on treatment patterns, Overall Survival (OS) and treatment effectiveness outcomes in the real-world setting. |