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Recruiting NCT04840264

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

Phase II Interventional Metastatic Gastric Adenocarcinoma Metastatic Gastroesophageal Junction Adenocarcinoma Peritoneal Carcinomatosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Docetaxel, Oxaliplatin, Fluorouracil.
Who it may be relevant to
Registry conditions: Metastatic Gastric Adenocarcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma, Peritoneal Carcinomatosis. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 60-day Obstruction Clearance Rate [Time frame: 60 days]
Secondary outcome measures (6)
  • 30-day Obstruction Clearance Rate [Time frame: 30 days]
  • Time to Obstruction Clearance [Time frame: 60 days]
  • Obstruction Clearance Duration [Time frame: 2 years]
  • Safety in terms of Adverse Events [Time frame: 2 years]
  • Overall Survival [Time frame: 2 years]
  • Quality of Life assessed by EORTC QLQ-OG25 [Time frame: 3 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Guangdong Provincial People's Hospital — Guangzhou

Publications

  • 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. PMID 17544243
  • 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. PMID 35274188

Identifiers

NCT: NCT04840264 · ZhenJing

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗