CClinicalTrials.gg
Status unknownNCT03475615Updated Mar 23, 2018

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

A Phase 3 interventional study of Oxaliplatin and Paclitaxel in Gastric Cancer and Stomach Neoplasms, sponsored by Fudan University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-23.

Sponsored by Fudan University · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
215
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Gastric Cancer
  • Stomach Neoplasms
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
215 participants (estimated)

Study arms

  • Experimental
    SOXP

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

  • Active comparator
    SOX

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

Interventions

  • DrugOxaliplatin

    130mg/m2, d1, q3w

  • DrugPaclitaxel

    40mg/m2 ip,d1、8 ,q3w

  • DrugS-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules)

    40mg/m2 Bid po,d1-14,q3w

05

What researchers measure

Primary outcomes

  1. overall survival

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

    Time frame: 10 months

06

Study locations

1 of 1 sites recruiting
  • Fudan University Cancer Hospital
    Shanghai, 200032, China
    • xiaodong Zhu, M.D · Contact · xddr001@163.com · 862164175590
    • xiaodong Zhu, M.D · Sub investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03475615
Lead sponsor
Fudan University
Responsible party
Xiaodong Zhu (MD, Fudan University) — Principal investigator
First posted
Mar 23, 2018
Start date
Mar 16, 2018
Primary completion
Dec 31, 2020 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Mar 23, 2018

Study contacts

Zhu Xiaodong, MD
Contact
xddr001@163.com
86-21-64175590

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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