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

NCT00522405 | Unknown Phase 2 DMC

• 2 other identifiers: A-39/29.1.2007ICMR No-5/8/7/26/99-ECD-I
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Transarterial chemoembolisation; Thalidomide; Capecitabine; Treatment

Outcome Measures

Primary Outcomes (1)

• Survival rate- calculated from the start of TACE

Secondary Outcomes (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

Study Arms (2)

1

ACTIVE COMPARATOR

Transarterial Chemoembolisation

Procedure: TACE

2

ACTIVE COMPARATOR

TACE Plus oral chemotherapy

Procedure: TACE

Interventions

TACE PROCEDURE

* 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

1; 2

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead
• Indian Council of Medical Research: collaborator

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

RECRUITING

Related Links

• All India Institute of Medical Sciences, New Delhi, India

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

• Subrat K Acharya, DM

  All India Institute of Medical Sciences, New Delhi, India

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Subrat K Acharya, D.M

CONTACT

91-11-26588500; subratacharya2004@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 27, 2007
• First Posted: August 29, 2007
• Study Start: October 1, 2007
• Primary Completion: August 1, 2014
• Study Completion: October 1, 2014
• Last Updated: July 16, 2012

Record last verified: 2007-08

Locations

IN (1)