Oral Chemotherapy Versus Supportive Therapy In The Treatment Of Unresectable Hepatocellular Carcinoma (OTCHCC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by All India Institute of Medical Sciences, New Delhi
Sponsor:
Information provided by (Responsible Party):
Subrat Kumar Acharya, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT01438450
First received: September 14, 2011
Last updated: July 12, 2012
Last verified: July 2012
  Purpose

Background Hepatocellular carcinoma, a malignant tumour 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 the investigators 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 transarterial chemoembolization (TACE) or Oral chemotherapy. Many patients also have involvement of branches of portal vein, which further limit therapeutic options. According to Barcelona Clinic Liver Cancer (BCLC) staging of liver cancer, involvement of portal vein precludes any standard form of therapy. These patients have been recommended for experimental therapies. Various forms of chemotherapy have been tried this group of patients. HCC is a vascular tumour and thalidomide is an anti-angiogenic drug and inhibits vascularity and has been used in the treatment of HCC. Capecitabine is a novel drug, which gives continuous delivery of 5-FU and has been used in patients with HCC and has been found to be safe.


Condition Intervention Phase
Hepatocellular Carcinoma
Drug: Oral
Other: Supportive
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: RCT Of Oral Thalidomide And Capecitabine Versus Supportive Therapy In The Treatment Of Unresectable Hepatocellular Carcinoma (BCLC D)

Resource links provided by NLM:


Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumour response [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Number of patients with side effects [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Patients developing various adverse events will be recorded

  • Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Change from baseline in Child status at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    Child status is calculated from the following 5 parameters

    1. Bilirubin < 2: 1, 2-3: 2 and > 3 : 3 points
    2. Albumin: > 3.5: 1, 2.8-3.5 : 2 and <2.8: 3 points
    3. Prothrombin time( seconds over control): 1-3: 1, 4-6: 2 and > 6: 3
    4. Encephalopathy: None: 1, (grade 1 and 2): 2 and (grade 3 and 4): 3
    5. Ascites: Absent: 1, slight: 2 and moderate: 3

    Child A: score 5-6, Child B: 7-9 and Child C: 10 or more



Estimated Enrollment: 74
Study Start Date: October 2007
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Supportive
Supportive therapy
Other: Supportive
No specific therapy will be given
Other Name: Supportive therapy
Active Comparator: Oral
Oral thalidomide and capecitabine
Drug: Oral

Capecitabine : 500 mg OD x 1 week 500 mg BD x 1 week 500 mg (2 morning, 1 evening) x 1 week After attaining the max dose of 1500 mg, a cycle of Capecitabine 1500mg every day for 2 weeks and 1 week off to be maintained.

Thalidomide: 50 mg OD x 1 week 100 mg OD x 1 week 200 mg OD x 1 week, 300 mg OD x 1 week

Other Name: Oral chemotherapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients above 12 years of age with
  • ECOG performance status (PST) score of 3 or above
  • Underlying Child's A and B cirrhosis
  • More than 50% involvement of liver by tumor
  • Thrombosed main portal vein
  • HV/IVC thrombosis
  • Extra hepatic disease
  • Metastatic disease
  • Informed written consent of patient

Exclusion Criteria:

  • History of drug allergy
  • Co-morbid illness like coronary artery disease, congestive heart failure, chronic renal failure etc
  • Pregnancy
  • Outstation patients from distant areas not in a position to follow up
  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: NCT01438450

Locations
India
All India Institute of Medical Sciences Recruiting
New Delhi, Delhi, India, 110029
Contact: Subrat K Acharya, DM    91-112658500 ext 4934    subratacharya2004@yahoo.com   
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
Principal Investigator: Subrat K Acharya, DM All India Institute of Medical Sciences, New Delhi
  More Information

No publications provided

Responsible Party: Subrat Kumar Acharya, Professor and Head, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT01438450     History of Changes
Other Study ID Numbers: ICMR- D.O No.5/8/7/26/99-ECD-1
Study First Received: September 14, 2011
Last Updated: July 12, 2012
Health Authority: India: Institutional Review Board

Keywords provided by All India Institute of Medical Sciences, New Delhi:
Thalidomide
Capecitabine
Advanced hepatocellular carcinoma
Therapy
Supportive care

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
Thalidomide
Capecitabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014