Gastric CancerPhase 3NCT01470742
Trial Comparing Capecitabine Plus Oxaliplatin (XELOX) and Capecitabine (X) as First-line Chemotherapy in Elderly Patients With Advanced Gastric Cancer
A Phase 3 study testing XELOX and XELODA in people with Gastric Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The objective of the trial is to compare Overall survival between capecitabine plus oxaliplatin (XELOX) and capecitabine (X) as first-line chemotherapy in elderly patients with advanced gastric cancer. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- XELOX and XELODA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2010to Dec 2015
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 70
- Histologically or cytologically confirmed adenocarcinoma of the gastric
- Advanced ,metastatic/recurrence gastric cancer
- ECOG performance status of 0 to 2
- Life expectancy≥3months
- No history of any systemic anti-cancer chemotherapy (prior adjuvant chemoradiation or chemotherapy is allowed if the last date of drug administration is > 6months from the study entry date)
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- No history of radiation therapy about Target lesion. (Prior radiotherapy is permitted if it was not administered to target lesions selected for this study, unless progression of the selected target lesions within the radiation portal is documented, and provided it has been completed at least 4 weeks before randomization.
- Adequate marrow functions (ANC ≥ 1,500/uL, PLT ≥100,000/uL)
- Adequate renal functions (Creatinine ≤1.5mg/dL or Ccr ≥ 50ml/min)
- Adequate hepatic functions ( bilirubin ≤ 2.0mg/dL, SGOT/SGPT < normal x 3)
- provision of a signed written informed consent
Who cannot join
- History of any medical or psychiatric condition
- Active infections
- Peripheral neuropathy with symptom(NCI-CTCAE ver. 3.0 >=Grade 1 )
- symptomatic brain metastases
- Double primary cancer (physician at the discretion of the other cancer cured the purpose of early cancer cases can be registered)
- History of other malignancy except:
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- Adequately treated non-melanomatous skin cancer or cervical carcinoma in situ
- Known hypersensitivity to Fluoropyrimidines/platinum
- Clinical significant cardiovascular disease (myocardial infarction, symptomatic coronary artery disease, congestive heart failure, severe arrhythmias)
- Required immunosuppressive therapy(transplant patients, severe autoimmune disease)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Phase III, Multicenter Clinical Trial Comparing Capecitabine Plus Oxaliplatin (XELOX) and Capecitabine (X) as First-line Chemotherapy in Elderly Patients With Advanced Gastric Cancer
The objective of the trial is to compare Overall survival between capecitabine plus oxaliplatin (XELOX) and capecitabine (X) as first-line chemotherapy in elderly patients with advanced gastric cancer.
- Conditions
- Gastric Cancer
- Being tested
- XELOX, XELODA
- 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
D1-14 Capecitabine 1000mg/m2 bid D1 Oxaliplatin 110mg/m2 + D5W 250ml over 2hr every 3weeks
XELODADrug
Capecitabine 1000mg/m2 bid D1-14 every 3weeks
| Study group | Role | What they receive |
|---|---|---|
| XELODA | Active comparator | Capecitabine 1000mg/m2 bid D1-14 every 3weeks Receives: Drug: XELODA |
| XELOX | Experimental | D1-14 Capecitabine 1000mg/m2 bid D1 Oxaliplatin 110mg/m2 + D5W 250ml over 2hr every 3weeks Receives: Drug: XELOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival of XELOX(XELODA/oxaliplatin) vs X(XELODA)
Measured: 36months
Secondary outcomes (1)
response rate
Measured: 36months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startSep 2010
- Primary completionFeb 2015
- Study completionDec 2015 (estimated)
Why it stopped: We stop because of problems such as insurance.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Ki Kang, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470742
- Sponsor's protocol ID
- 2010-04-118
- Status last verified
- Dec 2019
- First submitted
- 7 Nov 2011
- Last updated
- 30 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase III, Multicenter Clinical Trial Comparing Capecitabine Plus Oxaliplatin (XELOX) and Capecitabine (X) as First-line Chemotherapy in Elderly Patients With Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT01470742
- Acronym / sponsor ID
- 2010-04-118
- Conditions
- Gastric Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We stop because of problems such as insurance.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Feb 2015 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 11 Nov 2011 (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 objective of the trial is to compare Overall survival between capecitabine plus oxaliplatin (XELOX) and capecitabine (X) as first-line chemotherapy in elderly patients with advanced gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XELODA | Active comparator | Drug: XELODACapecitabine 1000mg/m2 bid D1-14 every 3weeks |
| XELOX | Experimental | Drug: XELOXD1-14 Capecitabine 1000mg/m2 bid D1 Oxaliplatin 110mg/m2 + D5W 250ml over 2hr every 3weeks |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- Age ≥ 70
- Histologically or cytologically confirmed adenocarcinoma of the gastric
- Advanced ,metastatic/recurrence gastric cancer
- ECOG performance status of 0 to 2
- Life expectancy≥3months
Key exclusion criteria (10 listed)
- History of any medical or psychiatric condition
- Active infections
- Peripheral neuropathy with symptom(NCI-CTCAE ver. 3.0 >=Grade 1 )
- symptomatic brain metastases
- Double primary cancer (physician at the discretion of the other cancer cured the purpose of early cancer cases can be registered)
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 |
|---|---|---|
| XELOXD1-14 Capecitabine 1000mg/m2 bid D1 Oxaliplatin 110mg/m2 + D5W 250ml over 2hr every 3weeks | Drug | XELOX |
| XELODACapecitabine 1000mg/m2 bid D1-14 every 3weeks | Drug | XELODA |
Primary outcome
Overall survival of XELOX(XELODA/oxaliplatin) vs X(XELODA)
Time frame: 36months
1 secondary outcome
response rate
Time frame: 36months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 XELODA in people with Gastric Cancer, run by Samsung Medical Center 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 11 inclusion and 10 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: withdrawn, as of the sponsor's last update on 30 Dec 2019. 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 withdrawn before enrolling participants, so there are no results.
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?
Overall survival of XELOX(XELODA/oxaliplatin) vs X(XELODA) (time frame: 36months). 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 30 Dec 2019.