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

Sponsor

Fudan University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03475615

Collaborator

(none)

215

Enrollment

Location

Arms

33.5

Anticipated Duration (Months)

6.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer Stomach Neoplasms	Drug: Oxaliplatin Drug: Paclitaxel Drug: S-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules)	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

215 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized Study of the Effect of First-line Intraperitoneal Paclitaxel in Combination With SOX Versus SOX Alone in Gastric Cancer Patients With Malignant Ascites

Actual Study Start Date :

Mar 16, 2018

Anticipated Primary Completion Date :

Dec 31, 2020

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SOXP	Drug: Oxaliplatin 130mg/m2, d1, q3w Drug: Paclitaxel 40mg/m2 ip，d1、8 ,q3w Drug: S-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules) 40mg/m2 Bid po，d1-14,q3w
Active Comparator: SOX	Drug: Oxaliplatin 130mg/m2, d1, q3w Drug: S-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules) 40mg/m2 Bid po，d1-14,q3w

Arm

Intervention/Treatment

Experimental: SOXP

Drug: Oxaliplatin

130mg/m2, d1, q3w

Drug: Paclitaxel

40mg/m2 ip，d1、8 ,q3w

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

40mg/m2 Bid po，d1-14,q3w

Active Comparator: SOX

Drug: Oxaliplatin

130mg/m2, d1, q3w

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

40mg/m2 Bid po，d1-14,q3w

Outcome Measures

Primary Outcome Measures

overall survival [10 months]
the internal between the date of enrollment and the date of death or last follow-up.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fudan University Cancer Hospital	Shanghai		China	200032

Sponsors and Collaborators

Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xiaodong Zhu, MD, Fudan University

ClinicalTrials.gov Identifier:

NCT03475615

Other Study ID Numbers:

FDZL-SOXP

First Posted:

Mar 23, 2018

Last Update Posted:

Mar 23, 2018

Last Verified:

Mar 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 23, 2018