Active — Not RecruitingPhase 2

Study of Sequential Systemic Therapy + Intraperitoneal Paclitaxel in Gastric/GEJ Peritoneal Carcinomatosis

United States40 participantsStarted 2021-02-18

Plain-language summary

This is a phase II clinical trial assessing the safety and efficacy of sequential systemic and intraperitoneal (IP) chemotherapy in patients with primary gastric/gastroesophageal junction cancer with cytology positive peritoneal lavage and/or peritoneal carcinomatosis.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Leukocytes: ≥ 2,000/mcL
✓. Absolute Neutrophil Count: ≥ 1,500/mcL
✓. Platelets: ≥ 80,000/mcL
✓. Total Bilirubin: within normal institutional limits
✓. AST(SGOT)/ALT(SPGT): ≤5 X institutional upper limit of normal
✓. Creatinine: \< 1.5 X institutional upper limit of normal
✓. Hemoglobin: \> 8.0 g/dL (may be transfused)
✓. Serum albumin: ≥ g/dL

Exclusion criteria

✕. Ongoing or active infection
✕. Symptomatic congestive heart failure
✕. Stroke (including transient ischemic attack \[TIA\]), myocardial infarction (MI), or other ischemic event,) within 3 months before initiation of treatment
✕. Unstable angina pectoris
✕. Cardiac arrhythmia

What they're measuring

Participants with Progression Free Survival at 1-Year

Timeframe: 1 year

Incidence of Treatment-Emergent Adverse Events [Safety]

Timeframe: 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.

Trial details

NCT IDNCT04762953

SponsorUniversity of California, Irvine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

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