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NCT Number: NCT04547153

Infusional Fluorouracil and Weekly Docetaxel for Gastric Cancer With Bone Marrow Involvement and DIC

A distinctive subtype of gastric adenocarcinoma with extensive bone marrow metastasis and DIC has been described. Few patients have been treated properly due to the lack of standard care. We designed this phase II study to evaluate a dose-dense regimen for this kind of highly aggressive gastric cancer (HAGC).

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Key information

Conditions

Gastric Cancer Blood Coagulation Disorders Bone Marrow Metastasis Digestive System Diseases Digestive System Neoplasms Disseminated Intravascular Coagulation Gastrointestinal Diseases Gastrointestinal Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms Thrombophilia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Jian Xiao

Guangzhou, Guangdong, 510655, China

About this study

5-fluorouracil 200mg/square metre/day continuously venous infusion on days 1-21; Docetaxel 25mg/square metre, on days 1, 8 and 15; This regimen repeats every 4 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ECOG PS 0-3;
  • Pathologically confirmed adenocarcinoma in stomach or esophagogastric junction;
  • Bone marrow metastasis confirmed by aspiration, biopsy or PET/CT scan;
  • overt DIC according to the International Society on Thrombosis and Haemostasis (ISTH) criteria;
  • Treatment-naive after the diagnosis of metastasis;
  • Platelet ≤ 50 * 10E9/L;
  • ALT≤5×ULN, AST≤5×ULN, Bilirubin≤5×ULN, Creatinine≤3×ULN;
  • Written informed consent.

Exclusion criteria

  • Concurrent aggressive malignancy;
  • Docetaxel containing perioperative treatment within 6 months;
  • Allergic to the study drugs;
  • Serious medical conditions, including severe heart disease, severe cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection,etc.
  • HIV positive;
  • MSI-H;
  • Her-2 gene overexpression;
  • Inadequate contraceptive measures.

Treatment and study plan

5-fluorouracil

Drug

200mg/square metre/day civ D1-D21

Other names: 5-Fu

docetaxel

Drug

25mg/square metre ivdrip D1, D8, D15

Other names: D

Primary outcomes

  1. hematological response rate (HeRR)

    Time frame: 2 months

    percentage of participants whose platelet restored to normal range

Secondary outcomes

  1. time to hematological response (TTHeR)

    Time frame: 2 months

    the interval from treatment to hematological response

  2. one-month mortality (OMM)

    Time frame: 30 days

    the proportion of participants who die within 30 days after the chemotherapy

  3. overall survival (OS)

    Time frame: 2 years

    from the start of chemotherapy to the date of death of any cause or censored at the last date known to be alive

  4. toxicities

    Time frame: 2 months

    in terms of incidence of adverse events, according to the National Cancer Institute Common Toxicity Criteria version 5.0

  5. quality of life assessed by EORTC QOL C-30 and STO-22 (QoL)

    Time frame: 3 months

    individual QoL based on questionnaire scores change from baseline to experimental treatment end and 28-day post-treatment

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Official study title

Infusional Fluorouracil and Weekly Docetaxel as First-line Therapy for Gastric Cancer With Bone Marrow Metastasis and Disseminated Intravascular Coagulation: a Multi-center, Phase II Trail

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 14, 2020
Registry last updated
Mar 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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