Gastric Carcinoma Stage IVPhase 3NCT01748851
XELOX Versus FOLFOX for Advanced Gastric Cancer (AGC)
A Phase 3 study testing XELOX and FOLFOX in people with Gastric Carcinoma Stage IV, run by Dong-A University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastric Carcinoma Stage IV
- What is being tested?
- XELOX and FOLFOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2012to Sep 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Gastric Carcinoma Stage IV
- Being tested
- XELOX, FOLFOX
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XELOXDrug
Also called Xeloda
capecitabine 1000mg/m2 bid po D1-D14
FOLFOXDrug
Also called 5-FU
5-FU 400mg/m2 iv push D1, 5-FU 1200mg/m2 over 22hr D1,D2
| Study group | Role | What they receive |
|---|---|---|
| XELOX | Experimental | Capecitabine 1000mg/m2 bid D1-D14 Oxaliplatin 130mg/m2 + 5% Dextrose water (5DW) 500ml over 2hour D1 Q 2weeks Receives: Drug: XELOX |
| FOLFOX | Active comparator | 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 Receives: Drug: FOLFOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: 6 months after treatment
Secondary outcomes (3)
Response rate
Measured: every 6 weeks up to 6 months
overall survival
Measured: 3 years later initial study start
performance status (quality of life)
European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 will be used.
Measured: Every 6 weeks up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionSep 2014
- Study completionSep 2014
Why it stopped: Poor enrollment of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Carcinoma Stage IVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung Yong Oh, Dong-A University Hospital
- Investigators
- Sung Yong Oh, M.D., Principal investigator, Dong-A University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748851
- Sponsor's protocol ID
- KCSG ST12-05
- Other IDs
- ML27924
- Status last verified
- Nov 2014
- First submitted
- 9 Dec 2012
- Last updated
- 4 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01748851
- Acronym / sponsor ID
- KCSG ST12-05
- Conditions
- Gastric Carcinoma Stage IV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment of patients
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Dong-A University HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 13 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XELOX | Experimental | Drug: XELOXCapecitabine 1000mg/m2 bid D1-D14 Oxaliplatin 130mg/m2 + 5% Dextrose water (5DW) 500ml over 2hour D1 Q 2weeks |
| FOLFOX | Active comparator | Drug: FOLFOXOxaliplatin 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XELOXAlso: Xelodacapecitabine 1000mg/m2 bid po D1-D14 | Drug | XELOX |
| FOLFOXAlso: 5-FU5-FU 400mg/m2 iv push D1, 5-FU 1200mg/m2 over 22hr D1,D2 | Drug | FOLFOX |
Primary outcome
Progression free survival
Time frame: 6 months after treatment
3 secondary outcomes
Response rate
Time frame: every 6 weeks up to 6 months
overall survival
Time frame: 3 years later initial study start
performance status (quality of life)
Time frame: Every 6 weeks up to 1 year
Results and safety
The study was stopped early (reason given: Poor enrollment of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2014.
Related trials for Gastric Carcinoma Stage IV
Active, not recruitingPhase 2
Ramucirumab and Trifluridine/Tipiracil or Paclitaxel for the Treatment of Patients With Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer
Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 3
mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma
Advanced Esophageal Adenocarcinoma, Advanced Gastric Adenocarcinoma
RecruitingPhase 2/3
Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial
Advanced Esophageal Adenocarcinoma, Advanced Gastric Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung Yong Oh, M.D. principal investigator
Dong-A University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing XELOX and FOLFOX in people with Gastric Carcinoma Stage IV, run by Dong-A University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Poor enrollment of patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 6 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2014.