Back to resultsClinical Efficacy of Trastuzumab in Combination With Capecitabine and Oxaliplatin for the Treatment of HER2-positive Advanced Gastric Cancer.
Primary Purpose
Advanced Gastric Carcinoma
Status
Completed
Phase
Phase 2
Locations
Bangladesh
Study Type
Interventional
Intervention
Trastuzumab
Oxaliplatin
Capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Gastric Carcinoma
Eligibility Criteria
Inclusion Criteria: HER2-positive AGC defined as either HER2 immunohistochemistry (IHC) 3+ or IHC 2+ and fluorescence in situ hybridization (FISH)+ with no history of previous treatment. Exclusion Criteria: -
Sites / Locations
- Bangabandhu Sheikh Mujib Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tras-Capox
Arm Description
Outcomes
Primary Outcome Measures
Loco-regional and Distant Tumor Control After Completion of Treatment
Response Evaluation Criteria in Solid Tumors was used to measure outcome:
Complete response (CR): Disappearance of all target lesions. Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions.
Progressive disease (PD): At least a 20% increase in the sum of diameters of target lesions.
Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Secondary Outcome Measures
Progression-free survival (PFS)
Overall survival (OS)
Full Information
NCT ID
NCT05997524
First Posted
August 6, 2023
Last Updated
August 15, 2023
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1. Study Identification
Unique Protocol Identification Number
NCT05997524
Brief Title
Clinical Efficacy of Trastuzumab in Combination With Capecitabine and Oxaliplatin for the Treatment of HER2-positive Advanced Gastric Cancer.
Official Title
Clinical Efficacy of Trastuzumab in Combination With Capecitabine and Oxaliplatin for the Treatment of HER2-positive Advanced Gastric Cancer: A Multicenter, Phase II Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
June 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Trastuzumab plus chemotherapy prolonged the median overall survival in patients with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer (AGC). Among chemotherapy regimens, oxaliplatin is generally more convenient and tolerable than cisplatin, and becoming an increasingly popular option for the treatment of AGC. The aim of the study was to evaluate the efficacy and safety of trastuzumab in combination with capecitabine and oxaliplatin (CAPOX) in HER2-positive AGC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Gastric Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tras-Capox
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Trastuzumab
Intervention Description
Trastuzumab was administered at a loading dose of 8 mg/kg followed by 6 mg/kg infusion every 3 weeks (q3w).
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
Oxaliplatin was administrated as a 130 mg/m2 infusion, q3w, for up to 6 cycles.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
Capecitabine 1000 mg/m2 was given orally twice daily on days 1-14 followed by a 7-day rest interval.
Primary Outcome Measure Information:
Title
Loco-regional and Distant Tumor Control After Completion of Treatment
Description
Response Evaluation Criteria in Solid Tumors was used to measure outcome:
Complete response (CR): Disappearance of all target lesions. Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions.
Progressive disease (PD): At least a 20% increase in the sum of diameters of target lesions.
Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS)
Time Frame
28 months
Title
Overall survival (OS)
Time Frame
28 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HER2-positive AGC defined as either HER2 immunohistochemistry (IHC) 3+ or IHC 2+ and fluorescence in situ hybridization (FISH)+ with no history of previous treatment.
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarwar Alam, MBBS, Mphil
Organizational Affiliation
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Official's Role
Study Chair
Facility Information:
Facility Name
Bangabandhu Sheikh Mujib Medical University
City
Dhaka
ZIP/Postal Code
1000
Country
Bangladesh
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Efficacy of Trastuzumab in Combination With Capecitabine and Oxaliplatin for the Treatment of HER2-positive Advanced Gastric Cancer.
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