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

This study has been completed.
Information provided by (Responsible Party):
Jian Xiao, Sixth Affiliated Hospital, Sun Yat-sen University Identifier:
First received: March 27, 2012
Last updated: November 6, 2014
Last verified: November 2014
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 Intervention Phase
Gastric Adenocarcinoma Drug: Docetaxel Drug: Fluorouracil Phase 2

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:

Further study details as provided by Jian Xiao, Sixth Affiliated Hospital, Sun Yat-sen University:

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

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

Enrollment: 39
Study Start Date: March 2012
Study Completion Date: April 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
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
Detailed Description:

Primary endpoint: Overall Response Rate

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


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01567618

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

Responsible Party: Jian Xiao, Principal Investigator, Sixth Affiliated Hospital, Sun Yat-sen University Identifier: NCT01567618     History of Changes
Other Study ID Numbers: SAHMO-04
Study First Received: March 27, 2012
Last Updated: November 6, 2014

Keywords provided by Jian Xiao, Sixth Affiliated Hospital, Sun Yat-sen University:
First line therapy
Gastric cancer

Additional relevant MeSH terms:
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 processed this record on September 19, 2017