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XELOX Versus FOLFOX for Advanced Gastric Cancer (AGC)

Primary Purpose

Gastric Carcinoma Stage IV

Status

Terminated

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

XELOX

FOLFOX

About this trial

This is an interventional treatment trial for Gastric Carcinoma Stage IV

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age :older than 20
A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in Spiral CT or multidetector CT (MD CT), or 20 mm or longer in conventional CT (it should be used by a consistent method during the study period). (RECIST v1.1)
*but, patients who does not have measureable lesion with metastatic resected M1 lymph node or bone metastasis or ascites could be enrolled.
No prior palliative chemotherapy (relapse 1 year later after end of adjuvant treatment available)
Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
The following laboratory test results:
① absolute neutrophil count (ANC) ≥1,500/micro Liter (uL), Platelet ≥ 100,000/uL,
② aspartate aminotransferase (AST) ≤ 3 x Upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 3 x ULN , Total bilirubin ≤ 2.0 mg/dL (in case of liver metastasis, 5 x ULN of AST, ALT)
③ Creatinine ≤ 1.5 mg/dL
A patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages.

Exclusion Criteria:

HER-2 Positive patients
Any other malignancies within the past 2 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
Subjects who received radiotherapy within 4 weeks prior to randomization
Subjects who have chronic or acute infection need to treatment
Subjects who received major operation within 4 weeks prior to randomization
patients with clinically significant (i.e. active) heart disease (e.g. congestive heart failure, symptomatic coronary artery diseases, cardiac arrhythmias, etc) or myocardial infarction within past 12 months.
patient with epilepsy or psychiatric problem including central nervous system(CNS) metastasis.
Subjects who not be able to ingestion or have a malabsorption disorder
peripheral neuropathy accompany with functional loss
Prior history of allergic reaction to study treatment drugs
A patient with history of other clinical trial within 4 weeks
A patient of childbearing potential without being tested for pregnancy at baseline for positive. (A postmenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential.)
subject who is decided by investigator decide exclusion with any other reasons

Sites / Locations

Dong-A University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

XELOX

FOLFOX

Arm Description

Capecitabine 1000mg/m2 bid D1-D14 Oxaliplatin 130mg/m2 + 5% Dextrose water (5DW) 500ml over 2hour D1 Q 2weeks

Oxaliplatin 85mg/m2 + 5DW 500ml over 2hr D1 Leucovorin 400mg/m2 + 5DW 500ml over 2hr D1 5-Fluorouracil (5-FU) 400mg/m2 IV PUSH D1 5-FU 1200mg/m2 + 5DW 1 Liter over 22hr D1-D2 Q 2weeks

Outcomes

Primary Outcome Measures

Progression free survival

Secondary Outcome Measures

Response rate

overall survival

performance status (quality of life)

European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 will be used.

Full Information

NCT ID

NCT01748851

First Posted

December 9, 2012

Last Updated

November 2, 2014

Sponsor

Dong-A University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01748851

Brief Title

XELOX Versus FOLFOX for Advanced Gastric Cancer (AGC)

Official Title

A Phase III Trial to Evaluate the Efficacy and Safety of the Combination Therapy of Capecitabine and Oxaliplatin (XELOX) in Comparison to the Combination Therapy of Fluorouracil/Folinic Acid and Oxaliplatin (FOLFOX) in Patients With AGC

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Terminated

Why Stopped

Poor enrollment of patients

Study Start Date

December 2012 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dong-A University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to identify the non-inferiority of the combination therapy of Capecitabine and Oxaliplatin compared with the combination therapy of Fluorouracil/Folinic acid and Oxaliplatin in patients with advanced gastric cancer.

Detailed Description

Quality assurance: Data will be collected, controlled, and monitored at the Korean Clinical Study Group (KCSG) data center. Data will be entered throuGh the E-Case report form (CRF) (Web based data input) Korean Clinical Study Group (KCSG) data center will do the standard Operating Procedures to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management Sample size assessment to specify the number of participants or participant years was consulted Statistical specialist. And data analysis will be also discuss with him Expected median progression-free survival(PFS) in Xelox: 6 months total number of events required: 359 197 patients will be needed After 10% of follow-up loss, 219 patients in each arm, a total of 438 patients will be enrolled

6. Conditions and Keywords

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

Gastric Carcinoma Stage IV

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

XELOX

Arm Type

Experimental

Arm Description

Capecitabine 1000mg/m2 bid D1-D14 Oxaliplatin 130mg/m2 + 5% Dextrose water (5DW) 500ml over 2hour D1 Q 2weeks

Arm Title

FOLFOX

Arm Type

Active Comparator

Arm Description

Oxaliplatin 85mg/m2 + 5DW 500ml over 2hr D1 Leucovorin 400mg/m2 + 5DW 500ml over 2hr D1 5-Fluorouracil (5-FU) 400mg/m2 IV PUSH D1 5-FU 1200mg/m2 + 5DW 1 Liter over 22hr D1-D2 Q 2weeks

Intervention Type

Drug

Intervention Name(s)

XELOX

Other Intervention Name(s)

Xeloda

Intervention Description

capecitabine 1000mg/m2 bid po D1-D14

Intervention Type

Drug

Intervention Name(s)

FOLFOX

Other Intervention Name(s)

5-FU

Intervention Description

5-FU 400mg/m2 iv push D1, 5-FU 1200mg/m2 over 22hr D1,D2

Primary Outcome Measure Information:

Title

Progression free survival

Time Frame

6 months after treatment

Secondary Outcome Measure Information:

Title

Response rate

Time Frame

every 6 weeks up to 6 months

Title

overall survival

Time Frame

3 years later initial study start

Title

performance status (quality of life)

Description

European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 will be used.

Time Frame

Every 6 weeks up to 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age :older than 20 A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in Spiral CT or multidetector CT (MD CT), or 20 mm or longer in conventional CT (it should be used by a consistent method during the study period). (RECIST v1.1) *but, patients who does not have measureable lesion with metastatic resected M1 lymph node or bone metastasis or ascites could be enrolled. No prior palliative chemotherapy (relapse 1 year later after end of adjuvant treatment available) Eastern Cooperative Oncology Group (ECOG) performance status 0 -2 The following laboratory test results: ① absolute neutrophil count (ANC) ≥1,500/micro Liter (uL), Platelet ≥ 100,000/uL, ② aspartate aminotransferase (AST) ≤ 3 x Upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 3 x ULN , Total bilirubin ≤ 2.0 mg/dL (in case of liver metastasis, 5 x ULN of AST, ALT) ③ Creatinine ≤ 1.5 mg/dL A patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages. Exclusion Criteria: HER-2 Positive patients Any other malignancies within the past 2 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri Subjects who received radiotherapy within 4 weeks prior to randomization Subjects who have chronic or acute infection need to treatment Subjects who received major operation within 4 weeks prior to randomization patients with clinically significant (i.e. active) heart disease (e.g. congestive heart failure, symptomatic coronary artery diseases, cardiac arrhythmias, etc) or myocardial infarction within past 12 months. patient with epilepsy or psychiatric problem including central nervous system(CNS) metastasis. Subjects who not be able to ingestion or have a malabsorption disorder peripheral neuropathy accompany with functional loss Prior history of allergic reaction to study treatment drugs A patient with history of other clinical trial within 4 weeks A patient of childbearing potential without being tested for pregnancy at baseline for positive. (A postmenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential.) subject who is decided by investigator decide exclusion with any other reasons

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sung Yong Oh, M.D.

Organizational Affiliation

Dong-A University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dong-A University Hospital

City

Busan

ZIP/Postal Code

602-715

Country

Korea, Republic of

12. IPD Sharing Statement

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XELOX Versus FOLFOX for Advanced Gastric Cancer (AGC)

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