NCT04840264

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for phase_2

Timeline
13mo left

Started Jan 2022

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Jan 2022Jun 2027

First Submitted

Initial submission to the registry

September 11, 2019

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

April 9, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

January 7, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

March 18, 2024

Status Verified

March 1, 2024

Enrollment Period

5 years

First QC Date

September 11, 2019

Last Update Submit

March 14, 2024

Conditions

Metastatic Gastric AdenocarcinomaMetastatic Gastroesophageal Junction AdenocarcinomaPeritoneal Carcinomatosis

Keywords

Malignant Bowel ObstructionDocetaxelOxaliplatinFluorouracil

Outcome Measures

Primary Outcomes (1)

  • 60-day Obstruction Clearance Rate

    proportion of participants who achieved obstruction clearance within 60 days from start of treatment

    60 days

Secondary Outcomes (6)

  • 30-day Obstruction Clearance Rate

    30 days

  • Time to Obstruction Clearance

    60 days

  • Obstruction Clearance Duration

    2 years

  • Safety in terms of Adverse Events

    2 years

  • Overall Survival

    2 years

  • +1 more secondary outcomes

Study Arms (3)

A (First-Line Therapy)

EXPERIMENTAL

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: DocetaxelDrug: OxaliplatinDrug: Fluorouracil

B (Second-Line Therapy)

EXPERIMENTAL

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: DocetaxelDrug: OxaliplatinDrug: Fluorouracil

C (Third- or Later-Line Therapy)

EXPERIMENTAL

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: DocetaxelDrug: OxaliplatinDrug: Fluorouracil

Interventions

DocetaxelDRUG

25 mg/square metre, D1, D8, D15, repeat every 4 weeks.

A (First-Line Therapy)B (Second-Line Therapy)C (Third- or Later-Line Therapy)
OxaliplatinDRUG

85 mg/msquare metre, D1, D15, repeat every 4 weeks.

A (First-Line Therapy)B (Second-Line Therapy)C (Third- or Later-Line Therapy)
FluorouracilDRUG

1200 mg/square metre, D1, D8, D15, repeat every 4 weeks.

Also known as: 5-FU
A (First-Line Therapy)B (Second-Line Therapy)C (Third- or Later-Line Therapy)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Sixth Affiliated hosipital, Sun Yat-Sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (2)

  • 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: 17544243BACKGROUND

  • 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: 35274188BACKGROUND

MeSH Terms

Conditions

Peritoneal Neoplasms

Interventions

DocetaxelOxaliplatinFluorouracil

Condition Hierarchy (Ancestors)

Abdominal NeoplasmsNeoplasms by SiteNeoplasmsDigestive System NeoplasmsDigestive System DiseasesPeritoneal Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination ComplexesUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jian Xiao, MD

    The Sixth Affiliated Hospital, Sun Yat-sen University

    STUDY CHAIR

Central Study Contacts

Jian Xiao, MD

CONTACT

86-20-38250745xiao_jian@139.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Medicine

Study Record Dates

First Submitted

September 11, 2019

First Posted

April 9, 2021

Study Start

January 7, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

March 18, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)