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Completed

NCT Number: NCT02903498

The Maintenance Treatment of UFT in Advanced Gastric Cancer

The purpose of this study is to evaluate the efficacy and tolerability of the maintenance treatment of tegafur-uracil (UFT) after the standard first-line chemotherapy in advanced gastric cancer.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically confirmed advanced or metastatic adenocarcinoma of the stomach
  • ECOG PS 0-2
  • At least one measurable or evaluable lesion in the first-line chemotherapy (5-FU based regimen: ECF/EOF/EOX/FOLFOX/XELOX) with the efficacy evaluation of non-PD
  • Adequate hepatic,renal,heart, and hematologic functions (platelets ≥75×109/L, neutrophil≥1.5×109/L, hemoglobin≥80 g/L, serum creatinine ≤1.5mg/dl, total bilirubin ≤1.5mg/dl, and serum transaminase≤2.5×the ULN)

Exclusion criteria

  • Receiving more or more than 2 regimens of chemotherapy
  • Pregnant or lactating women
  • Concurrent cancer
  • History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  • Neuropathy, brain, or leptomeningeal involvement
  • Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or high risk/uncontrolled arrhythmia
  • Uncontrolled significant comorbid conditions and previous radiotherapy

Treatment and study plan

UFT

Drug

UFT 360mg/m2 qd po d1-14, q3w

Other names: Uracil and Tegafur

Primary outcomes

  1. Progression Free Survival (PFS)

    Time frame: six weeks

    PFS is calculated from the start of treatment to disease progression or death

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: six weeks

    OS is calculated from the start to treatment to the death

  2. Number of Participants with Adverse Events

    Time frame: six weeks

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Phase II Study of the Maintenance Treatment of UFT (Uracil and Tegafur) After First-line

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Sep 16, 2016
Registry last updated
Oct 12, 2016

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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