Randomized Control Trial (RCT) of Transarterial Chemoembolization (TACE) Versus TACE and Oral Drug Therapy in the Treatment of Unresectable Hepatocellular Carcinoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified August 2007 by All India Institute of Medical Sciences, New Delhi.
Recruitment status was: Recruiting

Sponsor:

Collaborator:

Indian Council of Medical Research

Information provided by:

All India Institute of Medical Sciences, New Delhi

ClinicalTrials.gov Identifier:

NCT00522405

First received: August 27, 2007

Last updated: July 13, 2012

Last verified: August 2007

History of Changes

Purpose

Background Hepatocellular carcinoma, a malignant tumor of liver is one of the most common cancers worldwide. All India Institute Of Medical Sciences (AIIMS) being a tertiary care hospital receives about two to three cases of Hepatocellular carcinoma (HCC) each day in our Gastroenterology out patient department. Most of these patients present late when the disease is already advanced and no curative therapies can be offered. At this stage, palliative therapy forms the mainstay of treatment. This includes TACE or Oral chemotherapy. Whether oral chemotherapy administered along with TACE potentiates the effect and further prolongs survival, needs to be ascertained. No studies of this kind are available.

This prospective study is therefore designed to address this issue.

Condition	Intervention	Phase
Hepatocellular Carcinoma	Procedure: TACE	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment

Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:

Survival rate- calculated from the start of TACE

Secondary Outcome Measures:

a) Tumor response on dual phase CECT b) Patient tolerance c) Childs' status of cirrhosis- will be ascertained at one and two years of follow up depending upon the Childs' scoreScore <6- Childs'A, 7-9 Childs'B and >10 Childs'C


Study Start Date:	October 2007
Estimated Study Completion Date:	October 2014
Estimated Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Transarterial Chemoembolisation	Procedure: TACE Under local anesthesia, the Femoral artery would be punctured A catheter would be introduced and a flush aortogram, superior mesenteric arterioportography and the celiac artery run would be undertaken to define the size and location of the tumors, feeding vessels and to assess the portal vein patency Superselective catheterization of the hepatic artery feeding the tumor would be done By placing the catheter tip beyond the gastroduodenal artery, the chemotherapeutic drugs would be administered. Stable drug mixture would be prepared by using Doxorubicin 50mg, Cisplatin 100mg in combination with 10-15ml of ionic contrast media and 10-20ml of lipiodol by continuously agitating the mixture. The drug mixture would then be injected through the indwelling arterial catheter by continuously flushing alternately, repeatedly and rapidly between two-luer locks syringes connected across a three way. Gelfoam particles would be injected following this for embolization
Active Comparator: 2 TACE Plus oral chemotherapy	Procedure: TACE Under local anesthesia, the Femoral artery would be punctured A catheter would be introduced and a flush aortogram, superior mesenteric arterioportography and the celiac artery run would be undertaken to define the size and location of the tumors, feeding vessels and to assess the portal vein patency Superselective catheterization of the hepatic artery feeding the tumor would be done By placing the catheter tip beyond the gastroduodenal artery, the chemotherapeutic drugs would be administered. Stable drug mixture would be prepared by using Doxorubicin 50mg, Cisplatin 100mg in combination with 10-15ml of ionic contrast media and 10-20ml of lipiodol by continuously agitating the mixture. The drug mixture would then be injected through the indwelling arterial catheter by continuously flushing alternately, repeatedly and rapidly between two-luer locks syringes connected across a three way. Gelfoam particles would be injected following this for embolization

Arms

Assigned Interventions

Active Comparator: 1

Transarterial Chemoembolisation

Procedure: TACE

Under local anesthesia, the Femoral artery would be punctured
A catheter would be introduced and a flush aortogram, superior mesenteric arterioportography and the celiac artery run would be undertaken to define the size and location of the tumors, feeding vessels and to assess the portal vein patency
Superselective catheterization of the hepatic artery feeding the tumor would be done
By placing the catheter tip beyond the gastroduodenal artery, the chemotherapeutic drugs would be administered.
Stable drug mixture would be prepared by using Doxorubicin 50mg, Cisplatin 100mg in combination with 10-15ml of ionic contrast media and 10-20ml of lipiodol by continuously agitating the mixture.
The drug mixture would then be injected through the indwelling arterial catheter by continuously flushing alternately, repeatedly and rapidly between two-luer locks syringes connected across a three way.
Gelfoam particles would be injected following this for embolization

Active Comparator: 2

TACE Plus oral chemotherapy

Procedure: TACE

Under local anesthesia, the Femoral artery would be punctured
A catheter would be introduced and a flush aortogram, superior mesenteric arterioportography and the celiac artery run would be undertaken to define the size and location of the tumors, feeding vessels and to assess the portal vein patency
Superselective catheterization of the hepatic artery feeding the tumor would be done
By placing the catheter tip beyond the gastroduodenal artery, the chemotherapeutic drugs would be administered.
Stable drug mixture would be prepared by using Doxorubicin 50mg, Cisplatin 100mg in combination with 10-15ml of ionic contrast media and 10-20ml of lipiodol by continuously agitating the mixture.
The drug mixture would then be injected through the indwelling arterial catheter by continuously flushing alternately, repeatedly and rapidly between two-luer locks syringes connected across a three way.
Gelfoam particles would be injected following this for embolization

Show Detailed Description

Eligibility


Ages Eligible for Study:	12 Years to 80 Years (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients above 12 years of age with performance status (PST)score of 0-2
Unresectable HCC with underlying Child's A/B cirrhosis
Normal Main portal vein and its branches
Normal Inferior vena cava
No history of drug allergy
Informed written consent of patient.
Less than 50% involvement of liver by HCC

Exclusion Criteria:

Unresectable HCC with underlying Child's C cirrhosis
Performance status 3-5
Extrahepatic disease
Vascular involvement
Co-morbid illness like coronary artery disease, congestive heart failure, chronic renal failure etc
Previous history of encephalopathy/ upper gastrointestinal bleed in the last six months
HCC in a female of child bearing age

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00522405

Contacts


Contact: Subrat K Acharya, D.M	91-11-26588500 ext 4934	subratacharya2004@yahoo.com

Locations


India
All India Institute of Medical Sciences	Recruiting
New Delhi, Delhi, India, 110029
Sub-Investigator: Shashi B Paul, Ph.D
Sub-Investigator: Shivanand Gamanagatti, MD
Sub-Investigator: Kaushal Madan, DM
Sub-Investigator: Sreenivasa B Chalamalasetty, DM
Sub-Investigator: Sreenivas Vishnubhatla, Ph.D

Sponsors and Collaborators

All India Institute of Medical Sciences, New Delhi

Indian Council of Medical Research

Investigators


Principal Investigator:	Subrat K Acharya, DM	All India Institute of Medical Sciences, New Delhi, India

More Information

Additional Information:

All India Institute of Medical Sciences, New Delhi, India This link exits the ClinicalTrials.gov site


ClinicalTrials.gov Identifier:	NCT00522405 History of Changes
Other Study ID Numbers:	A-39/29.1.2007 ICMR No-5/8/7/26/99-ECD-I
Study First Received:	August 27, 2007
Last Updated:	July 13, 2012

Keywords provided by All India Institute of Medical Sciences, New Delhi:


Transarterial chemoembolisation Thalidomide Capecitabine Treatment

Additional relevant MeSH terms:


Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma	Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases

ClinicalTrials.gov processed this record on July 21, 2017

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