Docetaxel, Oxaliplatin and 5-FU for Gastric Cancer With Inoperable Malignant Bowel Obstruction

March 14, 2024 updated by: Jian Xiao, Sixth Affiliated Hospital, Sun Yat-sen University

A Multi-center, Non-randomized, Three-cohort, Phase II Trial of a Modified Triplet Combination of Docetaxel, Oxaliplatin and Fluorouracil for Gastric Cancer With Peritoneal Carcinomatosis and Inoperable Malignant Bowel Obstruction

This is a multi-center, non-randomized, 3-cohort, phase II trial, evaluating a triplet combination of docetaxel, oxaliplatin and fluorouracil for gastric cancer with peritoneal carcinomatosis and inoperable malignant bowel obstruction.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary study hypothesis is that the regimen will provide a clinically meaningful bowel obstruction clearance. This trial has 3 paralleled cohorts with the same experimental regimen: Cohort A (first-line therapy) will include 35 participants who have not received any palliative chemotherapy; Cohort B (second-line therapy) will include 22 participants who progress after the first-line therapy; Cohort C (third- or later-line therapy) plans to include 22 cases who have received two or more prior therapies for their metastatic disease.

Study Type

Interventional

Enrollment (Estimated)

79

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • The Sixth Affiliated hosipital, Sun Yat-Sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18-75 years of age;
  • ECOG PS ≤3;
  • pathologically diagnosed gastric or gastroesophageal junctional adenocarcinoma;
  • peritoneal carcinomatosis established by imaging data or pathological evidence;
  • MBO below the Treitz ligament based on clinical grounds or radiological findings;
  • considered as inoperable MBO by two independent surgical consultants;
  • Hb≥60g/L, WBC ≥4×10E9/L, ANC≥2×10E9/L，PLT≥100×10E9/L;
  • Cr≤ Upper Normal Limit(UNL);
  • Tbil≤1.5 UNL,AST≤1.5 UNL, ALT≤1.5 UNL, ALP≤1.5 UNL;
  • Written informed consent form paticipants.

Exclusion Criteria:

  • treated by a combination regimen containing all the study drugs;
  • allergy to any of the study drugs;
  • HER-2 amplification or overexpression, mismatch repair protein expression deletion (dMMR), or genetic testing suggestive of high microsatellite instability (MSI-H);
  • strangulated intestinal obstruction;
  • active gastrointestinal bleeding;
  • uncontrolled active infection;
  • unstable heart diseases with severe ECG abnormalities or affect clinical treatment (such as cardiac insufficiency, myocardial infarction, angina);
  • severe lung diseases (such as interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc);
  • mental disorders that affect clinical treatment or central nervous system diseases;
  • concomitant cerebral parenchymal or meningeal metastasis;
  • HIV infection or untreated active hepatitis;
  • bowel surgery or stenting required due to obstruction;
  • pregnant or lactating women;
  • other conditions that are not suitable for participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A (First-Line Therapy)
Docetaxel 25 mg/square metre, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85 mg/square metre, ivdrip 180 min, D1, D15; 5Fu 1200 mg/square metre, civ 24 hours, D1, D8, D15; Repeat every 4 weeks.
Drug: Docetaxel
25 mg/square metre, D1, D8, D15, repeat every 4 weeks.
Drug: Oxaliplatin
85 mg/msquare metre, D1, D15, repeat every 4 weeks.
Drug: Fluorouracil
1200 mg/square metre, D1, D8, D15, repeat every 4 weeks.
Other Names:
  • 5-FU
Experimental: B (Second-Line Therapy)
Docetaxel 25 mg/square metre, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85 mg/square metre, ivdrip 180 min, D1, D15; 5Fu 1200 mg/square metre, civ 24 hours, D1, D8, D15; Repeat every 4 weeks.
Drug: Docetaxel
25 mg/square metre, D1, D8, D15, repeat every 4 weeks.
Drug: Oxaliplatin
85 mg/msquare metre, D1, D15, repeat every 4 weeks.
Drug: Fluorouracil
1200 mg/square metre, D1, D8, D15, repeat every 4 weeks.
Other Names:
  • 5-FU
Experimental: C (Third- or Later-Line Therapy)
Docetaxel 25 mg/square metre, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85 mg/square metre, ivdrip 180 min, D1, D15; 5Fu 1200 mg/square metre, civ 24 hours, D1, D8, D15; Repeat every 4 weeks.
Drug: Docetaxel
25 mg/square metre, D1, D8, D15, repeat every 4 weeks.
Drug: Oxaliplatin
85 mg/msquare metre, D1, D15, repeat every 4 weeks.
Drug: Fluorouracil
1200 mg/square metre, D1, D8, D15, repeat every 4 weeks.
Other Names:
  • 5-FU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
60-day Obstruction Clearance Rate
Time Frame: 60 days
proportion of participants who achieved obstruction clearance within 60 days from start of treatment
60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day Obstruction Clearance Rate
Time Frame: 30 days
proportion of participants who achieved obstruction clearance within 30 days from start of treatment
30 days
Time to Obstruction Clearance
Time Frame: 60 days
interval from start of treatment to obstruction clearance
60 days
Obstruction Clearance Duration
Time Frame: 2 years
interval from obstruction clearance to the next malignant bowel obstruction
2 years
Safety in terms of Adverse Events
Time Frame: 2 years
according to Common Terminology Criteria for Adverse Events version 5.0
2 years
Overall Survival
Time Frame: 2 years
interval from start of treatment to death or last follow-up
2 years
Quality of Life assessed by EORTC QLQ-OG25
Time Frame: 3 months
in terms of European Organization for Research and Treatment of Cancer Quality of Life questionnair OG25
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Investigators

  • Study Chair: Jian Xiao, MD, The Sixth Affiliated Hospital, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

September 11, 2019

First Submitted That Met QC Criteria

April 8, 2021

First Posted (Actual)

April 9, 2021

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZhenJing

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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