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

Sponsors and Collaborators:	All India Institute of Medical Sciences, New Delhi Indian Council of Medical Research
Information provided by:	All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:	NCT00522405

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 Treatment	Procedure: TACE	Phase II Phase III

MedlinePlus related topics: Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Cisplatin Thalidomide Capecitabine Lipiodol Ethiodized oil Chlorotrianisene

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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

Arms	Assigned Interventions
1: Active Comparator 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
2: Active Comparator 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

1: Active Comparator

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

2: Active Comparator

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
Genders Eligible for Study:	Both
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

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, Delhi
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

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

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:	March 17, 2008
ClinicalTrials.gov Identifier:	NCT00522405
Health Authority:	India: All India Institute of Medical Sciences, New Delhi

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

Transarterial chemoembolisation
Thalidomide
Capecitabine

Study placed in the following topic categories:

Capecitabine
Liver Diseases
Digestive System Neoplasms
Thalidomide
Carcinoma, Hepatocellular
Liver neoplasms
Gelatin Sponge, Absorbable
Doxorubicin
Carcinoma

Liver Neoplasms
Digestive System Diseases
Cisplatin
Ethiodized Oil
Gastrointestinal Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Hepatocellular carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009