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Observational Prospective Study on Chemoembolization With Doxorubicin for Unresectable Hepatocellular Carcinoma (DEBDOX)

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ClinicalTrials.gov Identifier: NCT01891539
Recruitment Status : Recruiting
First Posted : July 3, 2013
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Giammaria Fiorentini, International Group of Endovascular Oncology

Brief Summary:

Hepatocellular carcinoma (HCC) is the fifth most common type of cancer in men and the seventh in women and is the third most common cause of death from cancer worldwide. The overall incidence of HCC remains high in developing countries and is steadily rising in most industrialized countries.

TACE with Doxorubicin-eluting beads (DEB-TACE) has recently been developed as a novel therapy option for HCC. In order to maximize its therapeutic efficacy, doxorubicin-loaded beads were developed to deliver higher doses of the chemotherapeutic agent and to prolong its permanence within the tumor. The comparison of efficacy and safety of TACE with drug-eluting microspheres in comparison with conventional TACE (cTACE) showed that response and time to progression in the group was significantly higher than that of the cTACE group. TACE with drug-eluting microspheres thus appears to be a feasible and promising approach to the treatment of HCC.

This study's purpose is evaluating treatment efficacy, survival rate and safety of TACE using drug-eluting microspheres loaded with doxorubicin for unresectable hepatocellular carcinoma.


Condition or disease
Liver Cell Carcinoma Non-resectable

Detailed Description:

This study's purpose is to assess treatment efficacy, survival rate and safety of TACE using drug-eluting microspheres loaded with doxorubicin for unresectable hepatocellular carcinoma.

Study Design: Prospective observational study . Primary objective: To collect data on tumor response after administration of drug-eluting microspheres that were preloaded with doxorubicin.

Secondary objectives: To collect data on survival rate, time to progression, tolerability of treatment, number of treatment required to achieve objective response and improvement of quality of life.

Treatment method:

Day -1 Doxorubicin at a dose of 35/50 mg/m2 has been charged onto 2 ml of microspheres at Pharmacy. It is suggested to dissolve Doxorubicin powder with 2 ml of contrast medium. The charging time of microspheres is at least 30 minutes.

Day 0: prehydration, antibiotic prophylaxis and setting up of a therapeutic scheme appropriate for analgesic prophylaxis (3-day duration) as previously reported (17)

Day +1:

Upon admittance to the radiology room, 1 vial of tropisetron (diluted in 100ml of physiological solution) and 1 vial of morphine hydrochloride diluted in 100 ml i.v. are administered by slow drip.

One vial of morphine hydrochloride diluted in 100 ml i.v. to be repeated one hour after the procedure and if necessary also after 6 hours.

Tropisetron i.v. if needed. Intra-arterial premedication (optional) with 1 vial of verapamil diluted in 4 ml of normal saline solution followed by 4 ml of lidocaine.

Tumor Infusion (segment/s with dominant disease) of Doxorubicin at a dose of 35/50 mg/m2 preloaded into 2 ml of 70-150 µm M1 microspheres.

A second tumor infusion is allowed if other lesions are present (daughter tumor), using Doxorubicin at a dose of 35/50 mg/m2 preloaded into 2 ml of 70-150 µm M1 microspheres (following radiologist and oncologist ' s planning of cure).

Day +30: The above procedure is repeated. Day +90: In case of response, a third administration following the above procedures will be repeated

Evaluation of response Response is assessed at 30, 90 and 180 days after TACE, monitoring tumor dimension using Chest-abdomen CAT scan with and without contrast medium, and cancer markers (CEA, Carbohydrate Antigen (CA) 19.9) Tumor response is performed according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria.

Assessment of quality of life Assessment of quality of life with alliative Performance Scale PPSv2 is performed during the baseline visit and 30, 60 and 180 days after treatment.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Observational Prospective Study on Chemoembolization Using Doxorubicin Drug-eluting Bead in Patients With Unresectable Hepatocellular Carcinoma
Study Start Date : May 2013
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Group/Cohort
doxorubicin

Day +1:

Lobar Infusion ( lobe with dominant disease) of Doxorubicin preloaded into 2 ml of drug-eluting microspheres.

Second lobar infusion of Doxorubicin preloaded into 2 ml of drug eluting microspheres can be administered at the same time contralaterally or in a further TACE Day +30: The above procedure is repeated. Day +90: In case of response, a third administration following the above procedures will be repeated




Primary Outcome Measures :
  1. tumor response [ Time Frame: 4 months ]
    CT scan evaluation according to RECIST 1.1


Secondary Outcome Measures :
  1. survival rate [ Time Frame: one year ]
    patients alive after 12 months

  2. time to progression [ Time Frame: 1 year ]
    time from start of therapy to progression



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic
Criteria

Inclusion Criteria:

  1. Patients with confirmed diagnosis of HCC
  2. Patient with HCC not suitable for radical therapies such as resection, liver transplantation or percutaneous therapies or patient is indicated for these therapies but there is a contraindication for them or patient rejects the above treatments
  3. Multinodular or single nodular tumor more than 5cm
  4. Hypervascular lesion showing contrast enhancement in the early stage after contrast media injection during CT or MRI.
  5. At least one uni-dimensional lesion measurable according to the Modified RECIST criteria by CT-scan or MRI
  6. No invasion in the blood vessel (hepatic portal, hepatic vein) or bile duct
  7. Eastern Cooperative Oncology Group performance status is 0 - 1
  8. Proper blood, liver, renal, heart functionality
  9. more than 18 years old
  10. Expected survival more than 6 months
  11. Prior written consent

Exclusion Criteria:

  1. Extrahepatic metastasis (Any lymph nodes measuring ≥ 10mm along the short axis)
  2. Tumor burden involving more than 50% of the liver
  3. History of biliary tract repair or endoscopic biliary tract treatment
  4. Clinically important refractory ascites or pleural fluid
  5. Any contraindications for hepatic embolization procedures
  6. Any contraindication for doxorubicin administration
  7. Contrast media allergy contraindicating angiography
  8. Acute or active cardiac, hepatic or renal diseases
  9. Pregnant, nursing or childbearing age women and men who are sexually active and don't want to or can't do contraception

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01891539


Contacts
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Contact: Donatella Sarti, PhD +39072136 ext 4018 igevo.datamanager@libero.it

Locations
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Italy
Azienda Ospedaliera Ospedali Riuniti Marche Nord, Presidio Ospedaliero San Salvatore Recruiting
Pesaro, PU, Italy, 61122
Contact: Giammaria Fiorentini, MD    +390721364124    giammaria.fiorentini@ospedalimarchenord.it   
Principal Investigator: Giammaria Fiorentini, MD         
Sponsors and Collaborators
International Group of Endovascular Oncology
Investigators
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Principal Investigator: Giammaria Fiorentini, MD International Group of Endovascular Oncology
Additional Information:
Publications of Results:
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Responsible Party: Giammaria Fiorentini, Dr., International Group of Endovascular Oncology
ClinicalTrials.gov Identifier: NCT01891539    
Other Study ID Numbers: DEBDOX01
First Posted: July 3, 2013    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Giammaria Fiorentini, International Group of Endovascular Oncology:
Hepatocellular carcinoma, doxorubicin, chemoembolization
Additional relevant MeSH terms:
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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