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.
Sponsor:
Information provided by (Responsible Party):
Hebei Tumor Hospital
ClinicalTrials.gov Identifier:
NCT01718626
First received: October 25, 2012
Last updated: November 5, 2012
Last verified: October 2012
  Purpose

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

  Eligibility

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

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
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 ClinicalTrials.gov identifier: NCT01718626

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

No publications provided

Responsible Party: Hebei Tumor Hospital
ClinicalTrials.gov 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
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014