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

This study is ongoing, but not recruiting participants.
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
  Contacts and Locations
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

No publications provided

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
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions processed this record on April 17, 2014