| CTRI Number |
CTRI/2016/08/007161 [Registered on: 05/08/2016] Trial Registered Retrospectively |
| Last Modified On: |
05/08/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare cause specific survival in control transarterial chemotherapy and transarterial chemotherapy Plus stereotactic body radiation therapy in Hepatocelluar carcinoma |
|
Scientific Title of Study
|
Randomized controlled trial of drug eluting beads based transarterial chemotherapy (TACE) with or without stereotactic body radiation therapy (SBRT) in patients with nonmetastatic unresectable hepatocellular carcinoma.(TACS-RT Study) |
| Trial Acronym |
TACE-SBRT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TMC IRB Project no 91 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Supriya Chopra |
| Designation |
Associate Professor and Radiation Oncologist |
| Affiliation |
Tata Memorial Centre ACTREC |
| Address |
Dept of Radiation Oncology Tata Memorial Centre TMC
Advanced Centre for Treatment Research & Education in Cancer ACTREC Kharghar Mumbai
Tata Memorial Centre TMC
Advanced Centre for Treatment Research & Education in Cancer ACTREC Kharghar Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
912227405113 |
| Fax |
912227405061 |
| Email |
schopra@actrec.gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Supriya Chopra |
| Designation |
Associate Professor and Radiation Oncologist |
| Affiliation |
Tata Memorial Centre ACTREC |
| Address |
Dept of Radiation Oncology Tata Memorial Centre TMC
Advanced Centre for Treatment Research & Education in Cancer ACTREC Kharghar Mumbai
Tata Memorial Centre TMC
Advanced Centre for Treatment Research & Education in Cancer ACTREC Kharghar Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
912227405113 |
| Fax |
912227405061 |
| Email |
schopra@actrec.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Supriya Chopra |
| Designation |
Associate Professor and Radiation Oncologist |
| Affiliation |
Tata Memorial Centre ACTREC |
| Address |
Dept of Radiation Oncology Tata Memorial Centre TMC
Advanced Centre for Treatment Research & Education in Cancer ACTREC Kharghar Mumbai
Tata Memorial Centre TMC
Advanced Centre for Treatment Research & Education in Cancer ACTREC Kharghar Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
912227405113 |
| Fax |
912227405061 |
| Email |
schopra@actrec.gov.in |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Centre, Parel Mumbai 12 Maharashtra |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre Tata Memorial Hospital |
| Address |
Tata Memorial Centre Tata Memorial Hospital Parel Mumbai 400012 Maharashtra India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Supriya Chopra |
ACTREC Tata Memorial Centre Kharghar |
1.Advanced Centre for Treatment Research & Education in Cancer ACTREC Tata Memorial Centre TMC Kharghar 410210
Mumbai
MAHARASHTRA
2. Tata Memorial Hospital Tata Memorial Centre Parel Mumbai 400012
Raigarh
MAHARASHTRA |
91-22-27405113
91-22-27405061
schopra@actrec.gov.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TMC- HEC Review Board, Institutional Review Board Parel, Mumbai 400012 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Liver Cancer, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arm 1.
DEB TACE
|
Patient randomized to DEB TACE arm will receive 3 cycles of DEB TACE. This will involve catheterization of the feeding vessels and injecting 100 mg of doxorubicin drug eluting beads. DEBTACE will be repeated after 4-6-weeks.Sorafenib will be omitted on the day of TACE and will be reinitiated 3-5 days after the TACE procedure |
| Comparator Agent |
Arm 2.
DEB TACE/SBRT
|
Patient randomized to the DEB TACE/SBRT arm will undergo 3 cycles of TACE and will concurrently receive sorafenib as in standard arm. SBRT will be initiated 4-6 weeks after last TACE procedure. During this period patients will stop sorafenib. SBRT once initiated will continue for 2-2.5 weeks. Sorafenib will be reinitiated 4 weeks after SBRT completion and will continue to be administered till progression or 12 months whichever is earlier. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion
Diagnosis of HCC
Age more than 18yrs
Barcelona Stage B Barcelona A not deemed suitable for surgery or refuse surgery.
Child pugh A Child pugh B score 7 out of 10
ECOG 0 to 1
Total number of measurable target lesion 2 or less than 2
Optimal predicted liver volume reserve more than 700 cc No contraindication for TACE.
Willing for molecular banking of tumour tissue. |
|
| ExclusionCriteria |
| Details |
Exclusion
Metastatic or nodal disease on staging investigations
Child C Cirrhosis or previous history of liver failure
Expected life span more than 6 months
Active variceal bleding or orther signs of hepatic decompensation
Portal venous thrombosis rendering patients unsuitable for TACE
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To campare two years overall survival OAS and one year infield progression free survival PFS in control TACE and interventional TACE plus SBRT arm |
two years for overall survival OAS and one year for infield progression free survival PFS respectively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare cause specific survival in control and intervention |
At study completion |
| To evaluate functional imaging MRI and PET characteristics predictive of therapeutic response and overall survival in patients with HCC |
At study completion |
| To compare quality of life QOL in control and intervention arm |
At study completion |
|
|
Target Sample Size
|
Total Sample Size="386"
Sample Size from India="386"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
11/12/2013 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="9"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a Phase II/III Randomized controlled trial of drug eluting beads based transarterial chemotherapy (TACE) and sorafenib with or without stereotactic body radiation therapy (SBRT) in patients with nonmetastatic unresectable hepatocellular carcinoma (TACS-RT)among 386 liver cancer patients. The primary aim of the study is 1 To compare overall survival OAS in control TACE and intervention arm TACE plus SBRT The secondary aims of the trial is 1 To compare cause specific survival in control and intervention. 2 To evaluate functional imaging (MRI& PET) characteristics predictive of therapeutic response and overall survival in patients with HCC. 3 To compare quality of life (QOL) in control and intervention arm. |