⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for Transarterial Chemoembolization Using Doxorubicin Beads With or Without Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Transarterial Chemoembolization Using Doxorubicin Beads With or Without Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery

Official Title: TACE-2: A Randomized Placebo-Controlled, Double Blinded, Phase III Trial of Sorafenib in Combination With Transarterial Chemoembolization in Hepatocellular Cancer

Study ID: NCT01324076

Conditions

Liver Cancer

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoembolization kills tumor cells by carrying drugs directly into the tumor and blocking the blood flow to the tumor. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether transarterial chemoembolization using doxorubicin-eluting beads is more effective when given with or without sorafenib tosylate in treating patients with liver cancer that cannot be removed by surgery. PURPOSE: This randomized phase III trial is studying giving transarterial chemoembolization using doxorubicin-eluting beads and sorafenib tosylate to see how well it works compared with giving transarterial chemoembolization using doxorubicin-eluting beads and a placebo in treating patients with liver cancer that cannot be removed by surgery.

Detailed Description: OBJECTIVES: Primary * To determine whether the addition of sorafenib tosylate to transarterial chemoembolization (TACE) with doxorubicin-eluting beads, compared to TACE alone, prolongs progression-free survival of patients with unresectable hepatocellular carcinoma. Secondary * To determine if adding sorafenib tosylate to TACE prolongs overall survival of these patients. * To determine if the sorafenib tosylate regimen prolongs time to progression in these patients. * To determine acceptable toxicity related to the sorafenib tosylate regimen in these patients. * To determine the effects of the sorafenib tosylate regimen on disease response, in terms of complete response, partial response, or stable disease, in these patients. * To determine the effects of the sorafenib tosylate regimen on quality of life of these patients. * To determine if treatment with the sorafenib tosylate regimen reduces the frequency for repeat TACE as measured by number of TACE procedures performed in 12 months. * To establish a blood sample bank linked to this study for biomarker research (proteomic and genomic analysis). OUTLINE: This is a multicenter study. Patients are stratified according to randomizing centers and serum alpha-fetoprotein levels (\< 400 ng/mL vs ≥ 400 ng/mL). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral sorafenib tosylate twice daily in the absence of disease progression or unacceptable toxicity. Beginning within 2-5 weeks after start of sorafenib tosylate, patients undergo transarterial chemoembolization (TACE) with doxorubicin-eluting beads. Patients may undergo additional sessions of TACE with doxorubicin-eluting beads, in the absence of complete devascularization of the tumor(s) (as assessed by follow-up contrast enhanced scan). * Arm II: Patients receive oral placebo twice daily in the absence of disease progression or unacceptable toxicity. Beginning within 2-5 weeks after start of placebo, patients undergo TACE with doxorubicin-eluting beads as in arm I. Patients with disease progression may cross over to the sorafenib tosylate arm at the discretion of the treating clinician and are followed for survival. Blood samples may be collected at baseline and periodically for pharmacogenetic and pharmacokinetic studies. Patients complete EORTC QoL questionnaire (QLQ-C30) version 3 and EORTC QLQ-HCC18 (a site-specific module for HCC) at baseline and periodically during the study. After completion of study therapy, patients are followed up periodically for 1 year. Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust, Birmingham, England, United Kingdom

Bristol Royal Infirmary, Bristol, England, United Kingdom

Aintree University Hospital, Liverpool, England, United Kingdom

Royal Free Hospital, London, England, United Kingdom

King's College Hospital, London, England, United Kingdom

Royal Marsden - London, London, England, United Kingdom

Queen's Medical Centre, Nottingham, England, United Kingdom

Southampton General Hospital, Southampton, England, United Kingdom

Contact Details

Name: Tim Meyer, MD, BSc, MRCP, PhD

Affiliation: Royal Free Hospital NHS Foundation Trust

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: