Study Comparing Sequential Therapy of S1+Docetaxel Followed by S1 to Concomitant S1+Docetaxel for Advanced Gastric Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Hebei Tumor Hospital.
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
Hebei Tumor Hospital Identifier:
First received: October 25, 2012
Last updated: November 5, 2012
Last verified: October 2012

Stage 1:First line therapy Sequential therapy of S1+Docetaxel followed by S1 is superior to concomitant S1+Docetaxel in the safety and clinical efficiency.

Stage 2:Second line therapy To explore the feasibility of single drug(S1) maintenance treatment for advanced gastric cancer.

Condition Intervention Phase
Gastric Cancer
Drug: S1+Docetaxel
Drug: S1+Docetaxel followed by S1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Hebei Tumor Hospital:

Primary Outcome Measures:
  • Progression-free survival(PFS) [ Time Frame: 1 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Objective response rate(ORR) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Disease control rate(DCR) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Overall survival(OS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: S1+Docetaxel Drug: S1+Docetaxel
Drug: S1 40-60mg, bid, days1-14, every 3 weeks Docetaxel 50mg/m2, day1, every 3 weeks, Patients will receive S1+Docetaxel until progression
Experimental: S1+Docetaxel followed by S1 Drug: S1+Docetaxel followed by S1
Drug: S1 40-60mg, bid, days1-14, every 3 weeks Docetaxel 50mg/m2, day1, every 3 weeks,for 4 cycles; S1 40-60mg, bid, days1-14, every 3 weeks Patients will receive S1+Docetaxel followed by S1 until progression


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed informed consent form
  • Performance Status-Eastern Cooperative Oncology Group (ECOG) 0-1
  • Histologically or cytologically confirmed gastric cancer
  • Advanced or recurrent, metastatic disease
  • At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors )
  • Life expectancy of at least 3 months
  • Target target lesion has not received radiotherapy or non target lesion radiation at least 4 weeks
  • Haematopoietic and Hepatic status:

Absolute neutrophil count >1.5x109/L,Platelet count > 100 x 109/L,Hemoglobin at least 9 g/dl,Bilirubin ≤ 1.5 x upper limit of normal (ULN),AST and ALT ≤ 2.5 times ULN(no liver metastasis), ≤5 times ULN(with liver metastasis)

  • Cardiovascular: Baseline LVEF 50% measured by echocardiography

Exclusion Criteria:

  • Symptomatic brain metastasis
  • Active or uncontrolled infection
  • Unresolved or unstable, serious toxicity from prior cancer treatment (any toxicities greater than grade 2; peripheral neuropathy of grade 2 or greater Symptomatic brain metastasis
  • Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, uncontrolled hypertension (≥ 180/110), unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen
  • History of other malignancy
  • Pregnant or lactating women
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Please refer to this study by its identifier: NCT01718626

China, Hebei
Department of Medical Oncology
Shijiazhuang, Hebei, China, 050011
Sponsors and Collaborators
Hebei Tumor Hospital
Principal Investigator: Wei Liu Hebei Tumor Hospital
  More Information

Responsible Party: Hebei Tumor Hospital Identifier: NCT01718626     History of Changes
Other Study ID Numbers: HBTH101 
Study First Received: October 25, 2012
Last Updated: November 5, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms by Site
Stomach Diseases
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators processed this record on May 26, 2016