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
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|
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.
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)
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|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|
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
- tumor response [ Time Frame: 4 months ]CT scan evaluation according to RECIST 1.1
- survival rate [ Time Frame: one year ]patients alive after 12 months
- time to progression [ Time Frame: 1 year ]time from start of therapy to progression
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
|Contact: Donatella Sarti, PhD||+39072136 ext email@example.com|
|Azienda Ospedaliera Ospedali Riuniti Marche Nord, Presidio Ospedaliero San Salvatore||Recruiting|
|Pesaro, PU, Italy, 61122|
|Contact: Giammaria Fiorentini, MD +390721364124 firstname.lastname@example.org|
|Principal Investigator: Giammaria Fiorentini, MD|
|Principal Investigator:||Giammaria Fiorentini, MD||International Group of Endovascular Oncology|