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

NCT03475615 | Unknown Phase 3

• 1 other identifier: FDZL-SOXP
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastric Cancer; Stomach Neoplasms

Outcome Measures

Primary Outcomes (1)

• overall survival

  the internal between the date of enrollment and the date of death or last follow-up.

  10 months

Study Arms (2)

SOXP

EXPERIMENTAL

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

SOX

ACTIVE COMPARATOR

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

Interventions

Oxaliplatin DRUG

130mg/m2, d1, q3w

SOX; SOXP

Paclitaxel DRUG

40mg/m2 ip，d1、8 ,q3w

SOXP

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

40mg/m2 Bid po，d1-14,q3w

SOX; SOXP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Oxaliplatin; Paclitaxel; S 1 (combination); Tegafur; gimeracil

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Fluorouracil; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Zhu Xiaodong, MD

CONTACT

86-21-64175590; xddr001@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: March 23, 2018
• Study Start: March 16, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 23, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)