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

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
S1+Docetaxel
S1+Docetaxel followed by S1
Sponsored by
Hebei Tumor Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Medical Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

S1+Docetaxel

S1+Docetaxel followed by S1

Arm Description

Outcomes

Primary Outcome Measures

Progression-free survival(PFS)

Secondary Outcome Measures

Objective response rate(ORR)
Disease control rate(DCR)
Overall survival(OS)

Full Information

First Posted
October 25, 2012
Last Updated
November 5, 2012
Sponsor
Hebei Tumor Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01718626
Brief Title
Study Comparing Sequential Therapy of S1+Docetaxel Followed by S1 to Concomitant S1+Docetaxel for Advanced Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hebei Tumor Hospital

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
S1+Docetaxel
Arm Type
Active Comparator
Arm Title
S1+Docetaxel followed by S1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
S1+Docetaxel
Intervention Description
Drug: S1 40-60mg, bid, days1-14, every 3 weeks Docetaxel 50mg/m2, day1, every 3 weeks, Patients will receive S1+Docetaxel until progression
Intervention Type
Drug
Intervention Name(s)
S1+Docetaxel followed by S1
Intervention Description
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
Primary Outcome Measure Information:
Title
Progression-free survival(PFS)
Time Frame
1 years
Secondary Outcome Measure Information:
Title
Objective response rate(ORR)
Time Frame
1 year
Title
Disease control rate(DCR)
Time Frame
1 year
Title
Overall survival(OS)
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Liu
Organizational Affiliation
Hebei Tumor Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medical Oncology
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050011
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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