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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Hepatocellular Carcinoma	Procedure: TACE	Phase 2; Phase 3

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Study Design

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Study Type :	Interventional (Clinical Trial)
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Study Start Date :	October 2007
Estimated Primary Completion Date :	August 2014
Estimated Study Completion Date :	October 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Survival rate- calculated from the start of TACE

Secondary Outcome Measures :

1. 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

Eligibility Criteria

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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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

All India Institute of Medical Sciences, New Delhi, India 

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
First Posted:	August 29, 2007
Last Update Posted:	July 16, 2012
Last Verified:	August 2007

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