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Taxanes or Platinum in Combination With Capecitabine Followed by Capecitabine Alone as First Line Treatment for Patients With Advanced Adenocarcinoma of Stomach or Esophagogastric Junction

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Capecitabine
capecitabine
Sponsored by
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric Cancer, capecitabine, maintenance treatment

Eligibility Criteria

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

Inclusion Criteria:

  1. Having signed informed consent
  2. Age≥ 18 years old
  3. Histologically confirmed gastric adenocarcinoma
  4. Unresectable recurrent or metastatic disease
  5. Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months
  6. Previous chemotherapy with oxaliplatin or cisplatin or paclitaxel or docetaxel, if applicable, more than 12 months.
  7. Measurable disease according to the RECIST criteria
  8. ECOG performance status ≤2
  9. Life expectancy of ≥3 month
  10. No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
  11. ALT and AST≤2.5 times ULN (≤5 times ULN in patients with liver metastases) Serum albumin level ≥3.0g/dL Serum creatinine ≤1.5ULN Bilirubin level ≤ 1.5 ULN WBC>3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet>90,000/mm3, Hb>8g/dl

Exclusion Criteria:

  1. Brain metastasis (known or suspected)
  2. Previous systemic therapy for metastatic gastric cancer
  3. Inability to take oral medication
  4. Previous therapy targeting at angiogenesis or vasculogenesis pathway or other targeted therapy
  5. Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry
  6. Allergic constitution or allergic history to any investigating agents.
  7. Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension.
  8. Pregnancy or lactation period
  9. Any investigational agent within the past 28 days
  10. Other previous malignancy within 5 year
  11. Pre-existing neuropathy>grade 1
  12. Legal incapacity

Sites / Locations

  • 307 Hospital of PLARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Taxanes or Platinum in combination with Capecitabine

chemotherapy followed by capecitabine alone

Arm Description

The patients will received chemotherapy combining capecitabine with platinum or taxanes until progression.

The patients who has received 4 cycle chemotherapy combining capecitabine with platinum or taxanes and the result was SD or CR or PR,will be given capecitabine alone until progression.

Outcomes

Primary Outcome Measures

Progression free survival

Secondary Outcome Measures

Tumor response rate
disease control rate
overall survival
adverse events

Full Information

First Posted
November 4, 2011
Last Updated
November 8, 2011
Sponsor
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01468389
Brief Title
Taxanes or Platinum in Combination With Capecitabine Followed by Capecitabine Alone as First Line Treatment for Patients With Advanced Adenocarcinoma of Stomach or Esophagogastric Junction
Official Title
A Randomized Multicenter Phase III Study:Taxanes or Platinum in Combination With Capecitabine Followed by Capecitabine Alone vs.Taxanes or Platinum Combined With Capecitabine in Advanced Adenocarcinoma of the Stomach or Esophagogastric Junction.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to investigate whether Taxanes or Platinum Plus Capecitabine With Capecitabine Maintenance Treatment as 1st line treatment in he advanced gastric cancer is effective and safe.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Gastric Cancer, capecitabine, maintenance treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Taxanes or Platinum in combination with Capecitabine
Arm Type
Active Comparator
Arm Description
The patients will received chemotherapy combining capecitabine with platinum or taxanes until progression.
Arm Title
chemotherapy followed by capecitabine alone
Arm Type
Experimental
Arm Description
The patients who has received 4 cycle chemotherapy combining capecitabine with platinum or taxanes and the result was SD or CR or PR,will be given capecitabine alone until progression.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
900-1000mg/m2 bid, days 1-14, every 3 weeks
Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Description
Dosing schedule: 900-1000mg/m2 bid, days 1-14, every 3 weeks Maintenance dosing schedule: 1000-1250mg/m2 bid, days 1-14, every 3 weeks
Primary Outcome Measure Information:
Title
Progression free survival
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Tumor response rate
Time Frame
1 year
Title
disease control rate
Time Frame
1 year
Title
overall survival
Time Frame
3 year
Title
adverse events
Time Frame
3 year

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: Having signed informed consent Age≥ 18 years old Histologically confirmed gastric adenocarcinoma Unresectable recurrent or metastatic disease Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months Previous chemotherapy with oxaliplatin or cisplatin or paclitaxel or docetaxel, if applicable, more than 12 months. Measurable disease according to the RECIST criteria ECOG performance status ≤2 Life expectancy of ≥3 month No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks ALT and AST≤2.5 times ULN (≤5 times ULN in patients with liver metastases) Serum albumin level ≥3.0g/dL Serum creatinine ≤1.5ULN Bilirubin level ≤ 1.5 ULN WBC>3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet>90,000/mm3, Hb>8g/dl Exclusion Criteria: Brain metastasis (known or suspected) Previous systemic therapy for metastatic gastric cancer Inability to take oral medication Previous therapy targeting at angiogenesis or vasculogenesis pathway or other targeted therapy Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry Allergic constitution or allergic history to any investigating agents. Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension. Pregnancy or lactation period Any investigational agent within the past 28 days Other previous malignancy within 5 year Pre-existing neuropathy>grade 1 Legal incapacity
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xu jianming, M.D.
Phone
861051128358
Email
jmxu2003@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xu jianming, M.D.
Organizational Affiliation
The Affiliated Hospital of the Chinese Academy of Military Medical Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
307 Hospital of PLA
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xu jianming, M.D.
Phone
86-10-66947176
Email
jmxu2003@yahoo.com
First Name & Middle Initial & Last Name & Degree
Zhao chuanhua
Phone
86-10-66947179
Email
chuanhuazhao@163.com

12. IPD Sharing Statement

Learn more about this trial

Taxanes or Platinum in Combination With Capecitabine Followed by Capecitabine Alone as First Line Treatment for Patients With Advanced Adenocarcinoma of Stomach or Esophagogastric Junction

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