Gastric CancerPhase 2NCT01798251
XELOX With Capecitabine Maintenance or XELOX in Elderly Metastatic Adenocarcinoma of Stomach
A Phase 2 study testing Oxaliplatin and Capecitabine in people with Gastric Cancer, run by Harbin Medical University at 1 site in China.
Trial summary
To confirm the efficacy and safety of XELOX with capecitabine maintenance in treatment of elderly advanced gastric cancer (AGC) by comparing it with that of XELOX regimen. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Oxaliplatin and Capecitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Dec 2015
- Phase
- Phase 2
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Ages Eligible for Study: 65 Years or older
- Genders Eligible for Study: Both
- The Eastern Cooperative Oncology Group (ECOG) status ≤ 2
- Histologically confirmed gastric adenocarcinoma(including LAUREN type).
- Measurable disease(according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1).
- chemotherapy naive after recurrence or metastasis. Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months.
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- Hb > 90g/L, neutrophil count > or = 1.5*10^9/L, platelet > or = 100*10^9/L, alanine transaminase (ALT) and aspartate aminotransferase (AST) < or = 2.5 times upper limit of nominal (ULN), alkaline phosphatase (ALP) < or = 2.5 times ULN, total bilirubin (TBIL) < 1.5 times ULN, serum albumin level > or = 30g/L, serum creatinine < 1 times ULN.
- No serious concomitant diseases which could lead to death within 5 years. At least 5 years from the last Biological/Immunotherapy/Hormone treatment for Malignancy excluding gastric cancer.
- Able to accept oral medication
- Compliance with protocol
Who cannot join
- Had received cytotoxic chemotherapy, radiotherapy or immunotherapy for this gastric cancer, excluding Corticosteroids.
- Other previous malignancy within 5 year, except curative skin cancer or carcinoma in situ of uterine cervix.
- Uncontrolled epilepsy, central nervous system disorders, or a history of mental disorders.
- clinically significant(i.e. active)cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) II or more serious congestive heart failure or severe requiring medication intervention arrhythmia, or history of myocardial infarction within the last 12 months.
- Upper gastrointestinal obstruction or physiological dysfunction or suffering from malabsorption syndrome, which could affect the absorption of capecitabine.
- Organ transplantation requires immunosuppressive treatment.
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- Severe uncontrolled recurrent infections, or Other serious uncontrolled concomitant diseases.
- Moderate or severe renal impairment(creatinine clearance (CCr) = or < 50 ml/min), or serum creatinine > ULN.
- Known enzyme deficiency of dihydropyrimidine dehydrogenase(DPD).
- Allergy to Oxaliplatin or any study medication ingredients.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The tumor hospital of Harbin medical university
Harbin, Heilongjiang, 150000
Yuxian BAI, PhD, 86 451 86298265, bai_yuxian@126.com
Hong SUI, PhD, 86 13936592698, doctorsui2003@126.com
About this study
Official title: A Randomized Single Center Phase II Study Comparing XELOX With Capecitabine Maintenance or XELOX Treatment in Elderly Metastatic Adenocarcinoma of Stomach
To confirm the efficacy and safety of XELOX with capecitabine maintenance in treatment of elderly advanced gastric cancer (AGC) by comparing it with that of XELOX regimen.
Read the detailed description
To investigate whether XELOX with capecitabine maintenance treatment as 1st line treatment in the elderly advanced gastric cancer is as effective and safe as XELOX regimen.
- Conditions
- Gastric Cancer
- Being tested
- Oxaliplatin, Capecitabine
- Keywords
- Elderly Gastric Cancer, Capecitabine Maintenance
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
Also called L-OHP
Oxaliplatin 100mg/m2 d1 Intravenous infusion every 3 weeks
CapecitabineDrug
Also called XELODA
capecitabine 850mg/m2 bid, d1-14, every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| XELOX-X | Experimental | XELOX: Oxaliplatin: 100mg/m2 d1 Intravenous infusion, every 3 weeks. Capecitabine: 850mg/m^2 bid, days 1-14, every 3 weeks and maximum 4 cycles, or progression/intolerance.
X Maintenance: Capecitabine 850mg/m^2 bid, days 1-14, every 3 weeks after 4 cycles XELOX regimen, until progression/intolerance. Receives: Drug: Oxaliplatin; Drug: Capecitabine |
| XELOX | Active comparator | XELOX: Oxaliplatin 100mg/m2 d1 Intravenous infusion, every 3 weeks. Capecitabine 850mg/m^2 bid, days 1-14, every 3 weeks, until progression/intolerance. Receives: Drug: Oxaliplatin; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Secondary outcomes (3)
overall survival (OS)
Measured: from the date of randomization until death from any cause or up to 1 year
Response Rate (RR)
Measured: evaluate every 6 weeks after the date of randomization until diease progress or up to 12 weeks
adverse events (AE)
Measured: from date of randomization to 28 days after the last chemo dosage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2015 (estimated)
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BAI Yuxian, Harbin Medical University
- Investigators
- Yuxian BAI, PhD, Principal investigator, The tumor hospital of Harbin medical university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01798251
- Sponsor's protocol ID
- CGOG20120101009
- Status last verified
- May 2013
- First submitted
- 13 Dec 2012
- Last updated
- 6 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Single Center Phase II Study Comparing XELOX With Capecitabine Maintenance or XELOX Treatment in Elderly Metastatic Adenocarcinoma of Stomach
- ClinicalTrials.gov ID
- NCT01798251
- Acronym / sponsor ID
- CGOG20120101009
- Conditions
- Gastric Cancer
- Keywords
- Elderly Gastric Cancer, Capecitabine Maintenance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 25 Feb 2013 (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.
To confirm the efficacy and safety of XELOX with capecitabine maintenance in treatment of elderly advanced gastric cancer (AGC) by comparing it with that of XELOX regimen.
Detailed description
To investigate whether XELOX with capecitabine maintenance treatment as 1st line treatment in the elderly advanced gastric cancer is as effective and safe as XELOX regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XELOX-X | Experimental | Drug: Oxaliplatin, Drug: CapecitabineXELOX: Oxaliplatin: 100mg/m2 d1 Intravenous infusion, every 3 weeks. Capecitabine: 850mg/m^2 bid, days 1-14, every 3 weeks and maximum 4 cycles, or progression/intolerance. X Maintenance: Capecitabine 850mg/m^2 bid, days 1-14, every 3 weeks after 4 cycles XELOX regimen, until progression/intolerance. |
| XELOX | Active comparator | Drug: Oxaliplatin, Drug: CapecitabineXELOX: Oxaliplatin 100mg/m2 d1 Intravenous infusion, every 3 weeks. Capecitabine 850mg/m^2 bid, days 1-14, every 3 weeks, until progression/intolerance. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Ages Eligible for Study: 65 Years or older
- Genders Eligible for Study: Both
- The Eastern Cooperative Oncology Group (ECOG) status ≤ 2
- Histologically confirmed gastric adenocarcinoma(including LAUREN type).
- Measurable disease(according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1).
Key exclusion criteria (10 listed)
- Had received cytotoxic chemotherapy, radiotherapy or immunotherapy for this gastric cancer, excluding Corticosteroids.
- Other previous malignancy within 5 year, except curative skin cancer or carcinoma in situ of uterine cervix.
- Uncontrolled epilepsy, central nervous system disorders, or a history of mental disorders.
- clinically significant(i.e. active)cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) II or more serious congestive heart failure or severe requiring medication intervention arrhythmia, or history of myocardial infarction within the last 12 months.
- Upper gastrointestinal obstruction or physiological dysfunction or suffering from malabsorption syndrome, which could affect the absorption of capecitabine.
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 |
|---|---|---|
| OxaliplatinAlso: L-OHPOxaliplatin 100mg/m2 d1 Intravenous infusion every 3 weeks | Drug | XELOX, XELOX-X |
| CapecitabineAlso: XELODAcapecitabine 850mg/m2 bid, d1-14, every 3 weeks | Drug | XELOX, XELOX-X |
Primary outcome
Progression Free Survival (PFS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
3 secondary outcomes
overall survival (OS)
Time frame: from the date of randomization until death from any cause or up to 1 year
Response Rate (RR)
Time frame: evaluate every 6 weeks after the date of randomization until diease progress or up to 12 weeks
adverse events (AE)
Time frame: from date of randomization to 28 days after the last chemo dosage
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2013.
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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.
Yuxian BAI, PhD principal investigator
The tumor hospital of Harbin medical university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxaliplatin and Capecitabine in people with Gastric Cancer, run by Harbin Medical University at 1 site in China.
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 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: status not confirmed, as of the sponsor's last update on 6 May 2013. 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 China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuxian BAI, PhD (86 451 86298265, bai_yuxian@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months). 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 6 May 2013.