A Study of Intraperitoneal Paclitaxel in Combination With SOX Compared With SOX Alone in Gastric Cancer With Malignant Ascites

Fudan University

Status and phase: Unknown; Phase 3

Conditions: Gastric Cancer; Stomach Neoplasms

Treatments: Drug: S-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules); Drug: Paclitaxel; Drug: Oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT03475615

FDZL-SOXP

Details and patient eligibility

About

This study is designed to compare the efficacy of intraperitoneal paclitaxel in combination with SOX, with SOX alone in the first-line treatment of gastric cancer with malignant ascites

Enrollment: 215 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• had a histologically proven adenocarcinoma of the gastroesophageal junction, or stomach that was locally advanced (inoperable) or metastatic
• malignant ascites(over pelvic cavity in CT scan and confirmed by cytology)
• an Eastern Cooperative Oncology Group performance status of 0 to 2
• adequate renal, hepatic, and hematologic function

Exclusion criteria

• previous chemotherapy or radiotherapy (unless in the adjuvant setting)
• uncontrolled cardiac disease, or other clinically significant, uncontrolled
• coexisting illness or previous or concurrent cancer
• HER2 positive and willing to use trastuzumab

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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215 participants in 2 patient groups

SOXP

Experimental group

Treatment:

Drug: Oxaliplatin

Drug: Paclitaxel

Drug: S-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules)

SOX

Active Comparator group

Treatment:

Drug: Oxaliplatin

Drug: S-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules)