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

NCT00522405 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2012-07-16

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Indian Council of Medical Research

    collaborator OTHER_GOV

  • All India Institute of Medical Sciences

    lead OTHER

Principal Investigators

  • Subrat K Acharya, DM · All India Institute of Medical Sciences, New Delhi, India

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2014-08-31
Completion
2014-10-31

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00522405 on ClinicalTrials.gov