Treatment Strategy for Stage IV Gastric Cancer with Positive Peritoneal Cytology As the Only Non-curable Factor

NCT02969122 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2024-09-19

No results posted yet for this study

Summary

Gastric cancer with positive is defined as stage IV disease in 7th AJCC/UICC TNM staging system. Controversy exists on the treatment of this part of patients. This trial aimed to explore the optimal treatment strategy for stage IV gastric cancer with positive peritoneal cytology as the only non-curable factor.

Conditions

  • Stomach Neoplasm

Interventions

PROCEDURE

standard gastrectomy with D2 lymphadenectomy

standard distal or total gastrectomy and accorded D2 lymphadenectomy

PROCEDURE

hyperthermic intraperitoneal chemotherapy

Intraperitoneal docetaxel of 100mg/m2 at 42℃ for 30 minutes

PROCEDURE

Extensive intraperitoneal lavage

Lavage of peritoneal cavity with 1000ml saline for 10 times

OTHER

Preoperative chemotherapy

Oxaliplatin 130mg/m2 D1 S-1 40-60mg Bid D1-14 Repeated every 3 weeks.

OTHER

Postoperative chemotherapy

SOX regimen postoperative chemotherapy (Oxaliplatin 130mg/m2 D1, S-1 40-60mg Bid D1-14, Repeated every 3 weeks) for surgery-first arm. Regimen for chemotherapy-first arm is determined according to the postoperative pathologic evaluation of response.

Sponsors & Collaborators

  • Peking University

    lead OTHER

Principal Investigators

  • Jiafu Ji, M.D. · Peking University Cancer Hospital & Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2024-09-09
Completion
2024-09-09

Countries

  • China

Study Locations

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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 NCT02969122 on ClinicalTrials.gov