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Intraperitoneal Paclitaxel With XELOX in Gastric Cancer With Peritoneal Metastasis

NCT04943653 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2021-07-06

No results posted yet for this study

Summary

IPXELOX will investigate the safety, tolerability, and antitumor activity of intraperitoneal paclitaxel in combination with chemotherapy in patients with advanced gastric cancer with peritoneal metastasis.

Study hypotheses: Intraperitoneal paclitaxel administered to subjects at the recommended phase 2 dose will show manageable safety and tolerability and anti-tumor efficacy with systemic capecitabine and oxaliplatin in advanced gastric cancer with peritoneal metastasis.

Conditions

  • Stomach Neoplasms
  • Paclitaxel
  • Peritoneal Metastases

Interventions

DRUG

Paclitaxel

intraperitoneal paclitaxel 20mg/BSA(Body Surface Area), 40mg/BSA, 60mg/BSA (phase I) recommended dose (phase II)

Sponsors & Collaborators

  • Seoul St. Mary's Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-08
Primary Completion
2023-12-31
Completion
2025-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04943653 on ClinicalTrials.gov