The Study of Intraperitoneal Docetaxel Plus S-1 for Malignant Ascites

NCT02779608 | Unknown Phase 2 DMC

• 1 other identifier: Ifen
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a clinical Study to evaluate the effect, survival benefit and safety of intraperitoneal docetaxel combined with oral S-1 for advanced gastric cancer with malignant ascites.

Conditions

Stomach Neoplasms; Peritoneal Metastasis

Keywords

malignant ascites

Outcome Measures

Primary Outcomes (1)

• response rate of ascites

  From date of enrollment to three cycles of treatment，the ascites is evaluated by the Japanese conventional five-point method

  9 weeks

Secondary Outcomes (2)

• one year survival rate

  1 year

• side effects of chemotherapy

  1 week to 18 weeks

Study Arms (1)

intraperitoneal docetaxel and oral S-1

EXPERIMENTAL

Docetaxel is diluted in 1litre normal saline and administered intraperitoneal（IP）at a dose of 60 mg/m2 over 1 hour on day 1. S-1 was administered orally twice daily at a dose of 40mg/m2 per day for 14 consecutive days, followed by 7 days of rest. Intervention: Drug: Intraperitoneal docetaxel Intervention：Drug：Oral S-1

Drug: intraperitoneal docetaxel; Drug: oral S-1

Interventions

intraperitoneal docetaxel DRUG

One peritoneal access port will be implanted in subcutaneous space of patients' abdominal wall after laparoscopic exploration.Then intraperitoneal docetaxel in 1litre normal saline will be administered through the port

Also known as: intraperitoneal chemotherapy

intraperitoneal docetaxel and oral S-1

oral S-1 DRUG

40mg/m² twice daily on day 1-14 every 3 weeks

Also known as: systemic chemotherapy

intraperitoneal docetaxel and oral S-1

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20-75years
• Histologic confirmation of gastric adenocarcinoma
• Positive peritoneal cytology or histological proven PM
• Ascites in CT scan
• Performance status (PS) ≤ 2 on Eastern Cooperative Oncology Group (ECOG) scale
• Adequate bone marrow and organ functions as defined below:
• Leucocyte≥3,000/ul Absolute neutrophil counts ≥1,500/uL Platelet≥100,000/uL Total bilirubin≤1.5mg/dl ALT，AST≤ 2x ULN serum creatinine ≤1.5mg/dl
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Provision of written informed consent

You may not qualify if:

• Presence of non-curable factors such as distant metastasis to liver or lung except of peritoneum
• Other severe medical conditions such as symptomatic infectious disease,active hemorrhage/bleeding, or obstructive bowel disease
• Life expectation ≤ 3 months
• With other malignant tumor
• allergy to therapeutic drugs

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Hyperthermic Intraperitoneal Chemotherapy; S 1 (combination); Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in general surgery, Huashan hospital Fudan University

Study Record Dates

• First Submitted: May 15, 2016
• First Posted: May 20, 2016
• Study Start: January 20, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: January 24, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)