Selective Internal Radiation Therapy (SIRT) Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients (DOORwaY90)
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ClinicalTrials.gov Identifier: NCT04736121 |
Recruitment Status :
Recruiting
First Posted : February 3, 2021
Last Update Posted : March 20, 2024
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Tracking Information | |||||||
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First Submitted Date ICMJE | January 27, 2021 | ||||||
First Posted Date ICMJE | February 3, 2021 | ||||||
Last Update Posted Date | March 20, 2024 | ||||||
Actual Study Start Date ICMJE | May 28, 2021 | ||||||
Estimated Primary Completion Date | June 2024 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Selective Internal Radiation Therapy (SIRT) Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients | ||||||
Official Title ICMJE | A Prospective, Multicenter, Open-label Single Arm Study Evaluating the Safety & Efficacy of Selective Internal Radiation Therapy Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients | ||||||
Brief Summary | The objective of this pivotal study is to evaluate the safety and effectiveness of SIRT using SIR-Spheres Y-90 resin microspheres as first-line treatment for local control of HCC in patients with Barcelona Clinic Liver Cancer (BCLC) stage A, B1, B2, and C. SIR-Spheres consist of biocompatible resin microspheres containing yttrium-90 (Y-90), with a size between 20 and 60 microns in diameter. Y-90 is a high-energy pure beta-emitting isotope with no primary gamma emission. SIR-Spheres are indicated for the local tumor control of unresectable hepatocellular carcinoma (HCC) in patients with Barcelona Clinic Liver Cancer (BCLC) stage A, B1 and B2, maximal single lesion size of 8 cm, no macrovascular invasion, well-compensated liver function and good performance status. It is also indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy (IHAC) of Floxuridine (FUDR). |
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Detailed Description | The investigation is a pivotal, prospective, multicenter, open-label single arm study evaluating treatment with hepatic arterial injection of SIR-Spheres. Up to 100 subjects will be treated (up to 150 consented) at up to 30 clinical sites in the United States. The population for this study includes patients diagnosed with HCC BCLC stage A, B1, B2, and C with maximal single lesion size of ≤ 8cm and who are not considered suitable for treatment by resection or eligible for ablation at time of study entry. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: A pivotal, prospective, multicenter, open-label single arm study Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Device: Resin microspheres containing yttrium-90 (Y-90)
Biocompatible resin microspheres are an injectable permanent implant and preferentially placed into the distal microvascular supply of tumors to provide direct irradiation of tissue and destruction of the microvascular bed. Spheres contain yttrium-90 (Y-90) and are a size between 20 and 60 microns in diameter.
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Study Arms ICMJE | Experimental: Open-label Single Arm
Open-label single arm study evaluating treatment with hepatic arterial injection of SIR-Spheres.
Intervention: Device: Resin microspheres containing yttrium-90 (Y-90)
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Publications * | Mahvash A, Chartier S, Turco M, Habib P, Griffith S, Brown S, Kappadath SC. A prospective, multicenter, open-label, single-arm clinical trial design to evaluate the safety and efficacy of 90Y resin microspheres for the treatment of unresectable HCC: the DOORwaY90 (Duration Of Objective Response with arterial Ytrrium-90) study. BMC Gastroenterol. 2022 Mar 28;22(1):151. doi: 10.1186/s12876-022-02204-1. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
100 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | June 2025 | ||||||
Estimated Primary Completion Date | June 2024 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||
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Administrative Information | |||||||
NCT Number ICMJE | NCT04736121 | ||||||
Other Study ID Numbers ICMJE | STX2001 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Sirtex Medical | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Sirtex Medical | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Bright Research Partners | ||||||
Investigators ICMJE |
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PRS Account | Sirtex Medical | ||||||
Verification Date | March 2024 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |