Study of Sequential Systemic Therapy + Intraperitoneal Paclitaxel in Gastric/GEJ Peritoneal Carcinomatosis (STOPGAP)
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|ClinicalTrials.gov Identifier: NCT04762953|
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : March 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer Peritoneal Carcinomatosis Gastroesophageal Junction Adenocarcinoma||Drug: Paclitaxel Drug: Leucovorin Drug: Fluorouracil||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This clinical trial is a non-randomized, open label, single arm clinical trial.|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Sequential Systemic Therapy Plus Intraperitoneal Paclitaxel in Gastric/GEJ Cancer Peritoneal Carcinomatosis (STOPGAP)|
|Actual Study Start Date :||February 18, 2021|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||June 2025|
Experimental: SingleArm: Systemic therapy and IP Paclitaxel in Gastric/GEJ Cancer Peritoneal Carcinomatosis
Patients will receive sequential intraperitoneal paclitaxel along with intravenous paclitaxel, 5-FU, and leucovorin on Days 1 and 8 of every 21 day cycle for 3 months.
Other Name: 5-FU
- Participants with Progression Free Survival at 1-Year [ Time Frame: 1 year ]Progression-free survival is defined as the duration of time from start of systemic treatment to time of progression, death, or clinical deterioration attributed to disease progression as judged by the investigator. Radiographic progression is defined using the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) as a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm and/or appearance of new lesions.
- Incidence of Treatment-Emergent Adverse Events [Safety] [ Time Frame: From date of study treatment initiation to first date of disease progression, toxicity, delay of treatment, or withdrawal of treatment, assessed up to 12 months after the last patient is enrolled. ]To evaluate the safety of IP paclitaxel and IV paclitaxel, 5-FU, and leucovorin in patients with primary gastric/GEJ adenocarinoma with peritoneal carcinomatosis determined by the incidence of treatment-emergent adverse events. Adverse events are based on the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0.
- Overall Survival of Participants [ Time Frame: From initiation of systemic treatment to up to 12 months after last patient is enrolled or until death from any cause. ]To assess the overall survival of participants from the start of systemic treatment to the death from any cause.
- Patient Reported Quality of Life Outcomes [ Time Frame: From initiation of study treatment until patient is off study, assessed up to 12 months after the last patient has started treatment. ]To assess the quality of life of participants such as mobility, self-care, daily activities, pain/discomfort and anxiety/depression and a visual analog scale (VAS). VAS consists of endpoints labeled best imaginable health status at the top and worse imaginable health state at the bottom having numeric values of 100 and 0 respectively.
- Expression of Plasma and Ascites Exosomal Gene Signature (EXOSIG) [ Time Frame: From date of registration to up to 12 months after last patient is enrolled. ]To assess the expression of plasma and ascites exosomal gene signature (EXO SIG) in patients with gastric cancer peritoneal carcinomatosis compared to healthy controls.
- Correlation of Plasma and Ascite Exosomal Gene Signature (EXOSIG) to Treatment Response [ Time Frame: From date of registration to up to 12 months after last patient is enrolled. ]To assess the correlation of changes in exosomal gene signature to treatment response in patients with gastric cancer peritoneal carcinomatosis.
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): NCT04762953
|Contact: Chao Family Comprehensive Cancer Center University of California, Irvineemail@example.com|
|Contact: University of California, Irvine Medical Center|
|United States, California|
|Chao Family Comprehensive Cancer Center, University of California, Irvine||Recruiting|
|Orange, California, United States, 92868|
|Contact: Maheswari Senthil, MD 877-827-8839 firstname.lastname@example.org|
|Principal Investigator:||Maheswari Senthil, MD||Chao Family Comprehensive Cancer Center|