Intra-arterial Gemcitabine vs. IV Gemcitabine and Nab-Paclitaxel Following Radiotherapy for LAPC (TIGeR-PaC)
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|ClinicalTrials.gov Identifier: NCT03257033|
Recruitment Status : Recruiting
First Posted : August 22, 2017
Last Update Posted : September 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Locally Advanced Pancreatic Cancer||Drug: Gemcitabine Drug: nab-paclitaxel Device: RenovoCath||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||320 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Subjects with stable or responding disease after approximately four months of induction therapy, and who are not surgical candidates will then be randomized to be in either the test group or control group. Crossovers are not allowed.|
|Masking:||None (Open Label)|
|Official Title:||Targeted Intra-arterial Gemcitabine vs. Continuation of IV Gemcitabine Plus Nab-Paclitaxel Following Induction With Sequential IV Gemcitabine Plus Nab-Paclitaxel and Radiotherapy for Locally Advanced Pancreatic Cancer|
|Actual Study Start Date :||March 12, 2018|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||September 2023|
Experimental: IA Therapy
IA Treatments with 1,000 mg/m2 gemcitabine administered through RenovoCath every other week for a maximum of 8 treatments for approximately 16 weeks.
Other Name: Gemzar
Other Name: RenovoCath RC120
Active Comparator: IV Therapy
IV gemcitabine and nab-paclitaxel will be administered for 16 weeks on days 1, 8, and 15 of a 28 day cycle. Nab-paclitaxel will be administered intravenously following pre-medication at a dose of 125 mg/m2 over 30 minutes followed by an infusion of gemcitabine at a dose of 1000 mg/m2 over 30 minutes.
Other Name: Gemzar
Other Name: Abraxane
- Overall Survival [ Time Frame: 3 Years ]OS from time of randomization will be calculated using the Kaplan-Meier method and compared between the test and control groups using the stratified Log-Rank Test
- Overall Survival for treatment received and unresected populations [ Time Frame: 3 Years ]The primary endpoint analysis will be repeated for the Treatment Received and Unresected Subject populations.
- Progression Free Survival [ Time Frame: 3 Years ]To compare the Progression Free Survival of intra-arterial delivery of gemcitabine using the RenovoCath™ device vs. continuation of IV gemcitabine and nab-paclitaxel following induction therapy with gemcitabine and nab-paclitaxel and radiation treatment for locally advanced pancreatic adenocarcinoma. Disease response and progression will be assessed according to RECIST 1.1.
- Objective response rate and duration of response [ Time Frame: 3 Years ]Objective response is defined as a complete response, CR, or partial response, PR, determined by Investigator assessment and confirmed by repeat assessment ≥ 4 weeks after initial documentation.
- Health Related Quality of Life [ Time Frame: 3 Years ]The EORTC questionnaire will be used to assess health related quality of life. The summary scores for the EORTC questionnaire will be calculated at baseline and follow-up.
- Neuropathy Assessment [ Time Frame: 1 Year ]The degree of neuropathy will be measured by the FACT/GOG-NTX-4 (version 4). The results will be cross tabulated by randomized treatment group for each study visit.
- Frequency of neutropenia [ Time Frame: 1 Year ]Neutropenia with onset after randomization requiring the use of filgrastim or other medications for white blood cell stimulation will be compared between the test and control groups through progression of disease.
- Patient reported symptoms [ Time Frame: 3 years ]Symptoms reported by subjects using the PRO-CTCAE questionnaire will be compared between the test and control groups through progression of disease.
- Safety, defined as adverse event rate, and tolerability, defined as occurrence of treatment discontinuation [ Time Frame: 3 years ]Safety and tolerability will be assessed by the occurrence of treatment discontinuation and the presence of adverse events
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): NCT03257033
|Contact: Charles Liemail@example.com|
|Contact: Nicole G Lamafirstname.lastname@example.org|
|Study Chair:||Michael J Pishvaian||Johns Hopkins Kimmel Cancer Center|