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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2007 by All India Institute of Medical Sciences, New Delhi
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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


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

  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
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:
No publications provided

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
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
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 29, 2014