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

Primary Purpose

Metastatic Gastric Adenocarcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma, Peritoneal Carcinomatosis

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Docetaxel
Oxaliplatin
Fluorouracil
Sponsored by
Sixth Affiliated Hospital, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Gastric Adenocarcinoma focused on measuring Malignant Bowel Obstruction, Docetaxel, Oxaliplatin, Fluorouracil

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-75 years of age;
  • ECOG PS 0-1, or ECOG PS 2-3 due to the tumor situation or obstruction;
  • Pathologically diagnosed gastric or gastroesophageal junction adenocarcinoma
  • Cohort 1 recruits patients with who have not received any previous therapy. Cohort 2 recruits patients who have received only one previous therapy for the metastatic disease. Cohort 3 recruits patients who have received two or more prior therapies for their metastatic disease.
  • Diagnosis of bowel obstruction below the Treitz ligament by clinical symptoms (nausea, vomiting, and constipation ± abdominal pain) and radiology.
  • Diagnosis of peritoneal metastasis by radiology or pathology.
  • Patient must be 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:

  • Patients who have previously been treated with the three experimental drugs together;
  • Severe uncontrolled active infection;
  • HIV infection or untreated active hepatitis;
  • HER-2 amplification or overexpression, mismatch repair protein expression deletion (dMMR), or genetic testing suggestive of high microsatellite instability (MSI-H);
  • Patients with heart diseases with severe ECG abnormalities or affect clinical treatment (such as cardiac insufficiency, myocardial infarction, angina);
  • Patients with severe lung diseases (such as interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.);
  • Patients with mental disorders that affect clinical treatment or have a previous history of central nervous system diseases;
  • Concomitant parenchymal or meningeal metastases;
  • Patients with active gastrointestinal bleeding;
  • Allergy to any of the study drugs;
  • Strangulated intestinal obstruction;
  • According to the judgment of the researchers, the patient needs to undergo bowel surgery or stenting due to obstruction;
  • Pregnant or lactating women, or patients of childbearing age who refuse to use effective contraception during the study period;
  • The researcher believes that the patient has any other conditions that are not suitable for participation in the study

Sites / Locations

  • The Sixth Affiliated hosipital, Sun Yat-Sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

A (First-Line Therapy)

B (Second-Line Therapy)

C (Third- or Later-Line Therapy)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

60-day Obstruction Clearance Rate
proportion of participants who achieved obstruction clearance within 60 days from start of treatment

Secondary Outcome Measures

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

Full Information

First Posted
September 11, 2019
Last Updated
September 30, 2023
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04840264
Brief Title
Docetaxel, Oxaliplatin and 5-FU for Gastric Cancer With Inoperable Malignant Bowel Obstruction
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 7, 2022 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Gastric Adenocarcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma, Peritoneal Carcinomatosis
Keywords
Malignant Bowel Obstruction, Docetaxel, Oxaliplatin, Fluorouracil

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
79 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A (First-Line Therapy)
Arm Type
Experimental
Arm Description
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.
Arm Title
B (Second-Line Therapy)
Arm Type
Experimental
Arm Description
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.
Arm Title
C (Third- or Later-Line Therapy)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
25 mg/square metre, D1, D8, D15, repeat every 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
85 mg/msquare metre, D1, D15, repeat every 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Fluorouracil
Other Intervention Name(s)
5-FU
Intervention Description
1200 mg/square metre, D1, D8, D15, repeat every 4 weeks.
Primary Outcome Measure Information:
Title
60-day Obstruction Clearance Rate
Description
proportion of participants who achieved obstruction clearance within 60 days from start of treatment
Time Frame
60 days
Secondary Outcome Measure Information:
Title
30-day Obstruction Clearance Rate
Description
proportion of participants who achieved obstruction clearance within 30 days from start of treatment
Time Frame
30 days
Title
Time to Obstruction Clearance
Description
interval from start of treatment to obstruction clearance
Time Frame
60 days
Title
Obstruction Clearance Duration
Description
interval from obstruction clearance to the next malignant bowel obstruction
Time Frame
2 years
Title
Safety in terms of Adverse Events
Description
according to Common Terminology Criteria for Adverse Events version 5.0
Time Frame
2 years
Title
Overall Survival
Description
interval from start of treatment to death or last follow-up
Time Frame
2 years
Title
Quality of Life assessed by EORTC QLQ-OG25
Description
in terms of European Organization for Research and Treatment of Cancer Quality of Life questionnair OG25
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jian Xiao, MD
Phone
86-20-38250745
Email
xiao_jian@139.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Xiao, MD
Organizational Affiliation
The Sixth Affiliated hospital, Sun Yat-Sen University
Official's Role
Study Chair
Facility Information:
Facility Name
The Sixth Affiliated hosipital, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Xiao, PhD
Phone
13711114566
Email
Xiaoj26@mail.sysu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17544243
Citation
Anthony T, Baron T, Mercadante S, Green S, Chi D, Cunningham J, Herbst A, Smart E, Krouse RS. Report of the clinical protocol committee: development of randomized trials for malignant bowel obstruction. J Pain Symptom Manage. 2007 Jul;34(1 Suppl):S49-59. doi: 10.1016/j.jpainsymman.2007.04.011. Epub 2007 Jun 4.
Results Reference
background
PubMed Identifier
35274188
Citation
Madariaga A, Lau J, Ghoshal A, Dzierzanowski T, Larkin P, Sobocki J, Dickman A, Furness K, Fazelzad R, Crawford GB, Lheureux S. MASCC multidisciplinary evidence-based recommendations for the management of malignant bowel obstruction in advanced cancer. Support Care Cancer. 2022 Jun;30(6):4711-4728. doi: 10.1007/s00520-022-06889-8. Epub 2022 Mar 10.
Results Reference
background

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

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