| CTRI Number |
CTRI/2014/12/005310 [Registered on: 17/12/2014] Trial Registered Prospectively |
| Last Modified On: |
01/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Study to Collect more detailed
information concerning TACE treatment followed by Sorafenib for hepatocellular
carcinoma (HCC) or without sorafenib after TACE enabling us to evaluate the
time to meet criteria for TACE non-eligibility |
|
Scientific Title of Study
|
Outcomes of HCC Patients Treated With TACE Followed or Not Followed by Sorafenib and the Influence of Timing to Initiate Sorafenib |
| Trial Acronym |
OPTMIS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 16560 |
Other |
| NCT01933945 |
ClinicalTrials.gov |
| NX1301/Ver 2.1/4 July 2013 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rahul Rathod |
| Designation |
Head- Medical Affairs |
| Affiliation |
Bayer Zydus Pharma Pvt Ltd |
| Address |
Kolshet road, Thane
Thane
MAHARASHTRA
400607
India |
| Phone |
912225311431 |
| Fax |
|
| Email |
rahul.rathod@bayerzyduspharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rahul Rathod |
| Designation |
Head- Medical Affairs |
| Affiliation |
Bayer Zydus Pharma Pvt Ltd |
| Address |
Kolshet road, Thane
Thane
MAHARASHTRA
400607
India |
| Phone |
912225311431 |
| Fax |
|
| Email |
rahul.rathod@bayerzyduspharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Rahul Rathod |
| Designation |
Head- Medical Affairs |
| Affiliation |
Bayer Zydus Pharma Pvt Ltd |
| Address |
Kolshet road, Thane
Thane
MAHARASHTRA
400607
India |
| Phone |
912225311431 |
| Fax |
|
| Email |
rahul.rathod@bayerzyduspharma.com |
|
|
Source of Monetary or Material Support
|
| Bayer Pharmaceuticals Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
Bayer pharmaceuticals Pvt Ltd |
| Address |
Kolshet Road, Thane (West)-400607 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Viet Nam
Slovakia
Spain
Sweden
Switzerland
Taiwan
Thailand
Turkey
Austria
Brazil
China
Denmark
Egypt
France
Greece
Hong Kong
Hungary
India
Indonesia
Israel
Japan
Kazakhstan
Mexico
New Zealand
Pakistan
Poland
Republic of Korea
Russian Federation
Singapore
Canada |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Joy Varghese |
Global Hospitals and Health City |
Senior Consultant, Dept of Hepatology and Liver Transplantation, Global Hopsitals and Health city,, 439, Cheran Nagar, Perumbakkam Chennai, Tamil Nadu 600100
Chennai
TAMIL NADU |
9566062200
joyvargese@gmail.com |
| Dr Shekhar Patil |
HCG Bangalore Institute of Oncology |
Consultant Medical Oncologist, HCG Bangalore Institute of Oncology, HCG Towers | Tower - IV | Room No.8 | P Kalinga Rao
Road | Sampangiram Nagar | Bangalore - 560027
Bangalore
KARNATAKA |
9341245961
spassociates6@gmail.com |
| DrNeeraj Saraf |
Medanta - The Medicity |
Medanta Medicity,Sec- 38, Gurgaon, HaryanaÂ
Gurgaon
HARYANA |
9899077795
neerajsaraf@hotmail.com |
| Ajay Duseja |
PGIMER |
"Associate Professor, PGI
Depatment of HEPATOLOGY
PGIMER
Chandigarh-160012
Chandigarh
CHANDIGARH |
01722759336
ajayduseja@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Global Hospital and Health City |
Approved |
| HCG Central Ethics committee |
Approved |
| Medanta Institutional Ethics Committee |
Approved |
| The Institutional Ethics Committee of PGIMER |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Carcinoma, Hepatocellular, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Procedure: TACE (transarterial chemoembolization)
Drug: Sorafenib (Nexavar, BAY43-9006) |
Its a prospective, open-label, multi-center, non-interventional study.Dose, frequency duration are based on the investigators’ treatment decisions. Route of administration - Oral (Sorafenib). Total duration of therapy - as per physician discretion. As per protocol, patient will be followed up till 18 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with histologically/cytologically documented or radiographically diagnosed HCC. Radiographic diagnosis needs typical findings of HCC by radiographic method i.e. on multi-dimensional dynamic CT, CT hepatic arteriography (CTHA)/CT arterial portography (CTAP) or MRI.
Patients with BCLC (Barcelona clinic liver cancer staging) stage B or higher.
Patients in whom a decision to treat with TACE has been made at time of study enrollment. Patients that have received one TACE in the past also can be enrolled, if the TACE was done at the same site and all required data about such previous TACEs are available. TACE includes both conventional TACE with lipidiol (or similar agents) and chemotherapeutic agent(s) and TACE with DC Beads excluding TAE without chemotherapeutic agent.
Patients with unresectable HCC (incurable with curative treatments including resection or ablation or not eligible for resection or local ablation)
Patients must have signed an informed consent form
Patients must have a life expectancy of at least 8 weeks
|
|
| ExclusionCriteria |
| Details |
Patients who have received TACE in the past but the data about TACE required in this protocol are not available
Patients who received any systemic anti-cancer therapy prior to the first TACE
Patients who are treated according to a trial protocol for intervention including a locoregional therapy or systemic therapy
Hospice patients
All contra-indications according to the local marketing authorization should be considered.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Overall survival |
Time Frame: Up to 3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Overall survival from initial TACE |
Time Frame: Up to 3 years |
| Progression-free survival from initial TACE |
Time Frame: Up to 3 years |
| Time to progression from initial TACE |
Time Frame: Up to 3 years |
| Tumor response according to mRECIST criteria |
Time Frame: Up to 3 years |
| Duration of treatment |
Time Frame: Up to 3 years |
| Number of patients with TEAEs (treatment emergent adverse events) |
Time Frame: Up to 3 years
|
|
|
Target Sample Size
|
Total Sample Size="1670"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="55" |
|
Phase of Trial
|
Post Marketing Surveillance |
Date of First Enrollment (India)
Modification(s)
|
28/05/2015 |
| Date of Study Completion (India) |
22/07/2017 |
| Date of First Enrollment (Global) |
07/10/2013 |
| Date of Study Completion (Global) |
22/07/2017 |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
The results of this study are intended to be published in a peer-reviewed journal and as
abstracts/presentations at medical congresses under the oversight of the sponsor. Current guidelines
and recommendation on good publication practice will be followed (e.g. GPP2 Guidelines35,
STROBE36). No individual investigator may publish on the results of this study, or their own patients,
without prior approval from the sponsor. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study will collect data of patients who are treated
with TACE followed by sorafenib for hepatocellular
carcinoma (HCC) or without sorafenib after TACE. In
contrast to a prior observational study on sorafenib
(GIDEON study, Marrero et al., ASCO 2011), where
pre-treatment with TACE was documented
retrospectively, this study will collect more detailed
information concerning TACE treatments in a
prospective manner. This will enable us to evaluate the
time to meet criteria for TACE non-eligibility. Outcome
of patients will be analyzed in relation to the timing of
initiation of sorafenib. It is planned to compare outcome
of patients with early start of Sorafenib treatment to
those without early start of sorafenib treatment after
TACE. In addition, practice patterns of the physicians involved in the care of patients with HCC under real-life
conditions will be evaluated.
|