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Sponsors and Collaborators: |
All India Institute of Medical Sciences, New Delhi Indian Council of Medical Research |
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Information provided by: | All India Institute of Medical Sciences, New Delhi |
ClinicalTrials.gov Identifier: | NCT00522405 |
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 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Transarterial Chemoembolisation
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Procedure: TACE
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2: Active Comparator
TACE Plus oral chemotherapy
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Procedure: TACE
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Ages Eligible for Study: | 12 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Subrat K Acharya, D.M | 91-11-26588500 ext 4934 | subratacharya2004@yahoo.com |
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 |
Principal Investigator: | Subrat K Acharya, DM | All India Institute of Medical Sciences, New Delhi, India |
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 |
Transarterial chemoembolisation Thalidomide Capecitabine |
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 |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |