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A Randomized Phase II/III Trial of Intraperitoneal Paclitaxel Plus Systemic Treatment vs Systemic Treatment Alone in Gastric Carcinomatosis - STOPGAP II

Short Title: EA2234


Enrollment Status: Recruiting

NCT #: NCT07001748

Specialty Area: Oncology

Condition Studied: Gastric Carcinomatosis

Age Groups: Adult; Older Adult

Phase: II/III


Study Information

Summary / Purpose

The purpose of this study is to compare the usual treatment, systemic therapy (chemotherapy), to the study treatment, paclitaxel administered through a tube in your belly plus systemic therapy (chemotherapy).

Study Type: Interventional
Accepts Healthy Volunteers: No

Who Can Participate

Eligibility Criteria:
  • Adults 18+ years of age
  • Confirmed peritoneal carcinomatosis or gastric/gastroesophageal adenocarcinoma
  • Must have received between 3-6 months of first line systemic treatment
  • No evidence of bowel obstruction

What's Involved

Participation in the study will include:
  • A diagnostic laparoscopy, a minimally invasive surgery performed under general anesthesia, in which small incisions are made in the abdomen
  • Random assignment during the laparoscopy to receive either standard chemotherapy given intravenously (IV) alone, or standard IV chemotherapy plus paclitaxel delivered directly into the abdominal cavity
  • Placement of an intraperitoneal port, a small device placed under the skin of the upper abdomen with a tube into the abdomen, for participants assigned to that group
  • Imaging with computed tomography (CT), magnetic resonance imaging (MRI), or both
  • Blood sample collection
  • Additional diagnostic laparoscopies if needed

Principal Investigator

Additional Information

Location: Renown Health, Office of Clinical Research
Address:

1500 E 2nd St. Reno, NV 89502

General Research: 775-982-3646
Oncology Research: 775-982-5050
Email: Renown-CRD@renown.org

Disclaimer: This listing gives you general information about the study and isn't part of the official consent process. If you decide to learn more, the research team will talk with you and check if you meet any additional requirements to join the study.

ER Wait Times

How are wait times calculated?

Our estimated ER wait times reflect the average time from check-in to being seen by a medical professional during triage, where patients are prioritized based on the severity of their condition.