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Dose-dense Biweekly Docetaxel Combined With 5-fluorouracil as First-line Treatment in Advanced Gastric Cancer (DaeMon)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01567618
Recruitment Status : Completed
First Posted : March 30, 2012
Last Update Posted : November 7, 2014
Information provided by (Responsible Party):
Jian Xiao, Sixth Affiliated Hospital, Sun Yat-sen University

Brief Summary:
This is an open-label, phase II study to evaluate the efficacy and safety of biweekly docetaxel and DeGramont regimen on unresectable gastric adenocarcinoma in the first-line therapy.

Condition or disease Intervention/treatment Phase
Gastric Adenocarcinoma Drug: Docetaxel Drug: Fluorouracil Phase 2

Detailed Description:

Primary endpoint: Overall Response Rate

Secondary endpoint: Time to progression, overall survival, safety data

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial Evaluating Biweekly Docetaxel and DeGramont Regimen in First-Line Treatment of Unresectable or Metastatic Gastric Adenocarcinoma (DaeMon)
Study Start Date : March 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Docetaxel

    Docetaxel 50mg/m2 iv drip, repeat every two weeks;

    Efficacy will be evaluated every three cycles.

  • Drug: Fluorouracil
    Fluorouracil 400mg/m2 iv D1; Fluorouracil 2400mg/m2 civ 46 hours; repeat fortnightly and evaluate every two cycles

Primary Outcome Measures :
  1. Overall response rate according to RECIST 1.1 [ Time Frame: One Year ]

Secondary Outcome Measures :
  1. Time to progression [ Time Frame: One year ]
  2. Overall survival [ Time Frame: One year ]
  3. Incidence of grade 3 or 4 toxicity [ Time Frame: One year ]
    The criteria to grade the toxicity is NCI CTC 3.0

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed written informed consent
  • Patients with histologically or cytologically confirmed unresectable gastric adenocarcinoma whose ECOG performance status are 0-2
  • Presence of measurable disease by radiographic study (including CT or MRI scan, or chest x-ray) or physical examination
  • At least 3 weeks since last major surgery
  • At least 12 months since last adjuvant chemotherapy
  • At least 6 weeks since prior radiotherapy providing that the extent and site of radiotherapy fields are such that marked bone marrow suppression is NOT expected
  • Patients who have received palliative radiotherapy must have recovered from any reversible toxic effects e.g. nausea and vomiting caused by radiation of fields
  • Patients with reproductive potential must use effective BC;
  • Required Screening Laboratory Criteria:

Hemoglobin 90g/L WBC 3.5 x 109/L Neutrophils 1.5 x 109/L Platelets 100 x 109/L Creatinine 133 umol/L and creatinine clearance 60 mL/min

  • A probable life expectancy of at least 6 months;

Exclusion Criteria:

  • Brain metastases
  • Female of childbearing potential, pregnancy test is positive
  • Concomitant malignancies or previous malignancies other than gastric cancer within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or low grade prostate cancer
  • Active infection
  • Concurrent severe medical problems unrelated to the malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk
  • Sexually active patients refusing to practice adequate contraception; Patients with conditions which might affect absorption of an oral drug (for example intermittent obstruction) unless discussed and agreed with principal investigator
  • History of grade 3 or 4 toxicity to fluoropyrimidines

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01567618

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China, Guangdong
Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510655
Sponsors and Collaborators
Sixth Affiliated Hospital, Sun Yat-sen University

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Responsible Party: Jian Xiao, Principal Investigator, Sixth Affiliated Hospital, Sun Yat-sen University Identifier: NCT01567618     History of Changes
Other Study ID Numbers: SAHMO-04
First Posted: March 30, 2012    Key Record Dates
Last Update Posted: November 7, 2014
Last Verified: November 2014
Keywords provided by Jian Xiao, Sixth Affiliated Hospital, Sun Yat-sen University:
First line therapy
Gastric cancer
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs