Advanced Gastric CancerPhase 2GZH-001NCT02038621
The Maintenance Therapy of Capecitabine of Advanced Gastric Cancer
A Phase 2 study testing Paclitaxel and Oxaliplatin and Capecitabine in people with Advanced Gastric Cancer, run by The Second People's Hospital of Sichuan.
Trial summary
To confirm the efficacy and safety of XELOX with capecitabine maintenance in treatment of advanced gastric cancer (AGC) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Gastric Cancer
- What is being tested?
- Paclitaxel and Oxaliplatin and Capecitabine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Dec 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- male or female
- Patients with stage IV gastric cancer by pathology or cytology and imaging diagnosis , or after previous surgery or radiotherapy or chemotherapy in patients with stage IV gastric cancer progression , there RECIST criteria evaluable lesions ;
- ECOG performance status score 0-2 ;
- Expected survival time more than three months ;
- Adequate hematologic parameters and liver and kidney function ;
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- Bone marrow : absolute neutrophil count (ANC) ≥ 1.5 × 109 / L, platelets ≥ 75 × 109 / L, hemoglobin ≥ 80g / L;
- Liver: bilirubin ≤ 1.5 times the upper limit of normal , ALT AST values ≤ 2.5 times the upper limit of normal ;
- Renal : serum creatinine ≤ ULN ;
- Informed consent of patients or their agents , and signed informed consent.
Who cannot join
- For patients allergic to capecitabine ;
- Patients with CNS metastases
- Undermine the integrity of the upper gastrointestinal tract , malabsorption syndrome , or unable to take oral medication ;
- Patients with coronary heart disease , angina , myocardial infarction , arrhythmia, cerebral thrombosis, stroke and other serious cardiovascular and cerebrovascular disease ;
- Or in combination with other anti-tumor therapy in patients participating in clinical trials of other interventions ;
- Pregnancy or breast-feeding patients , or fertility without taking adequate contraceptive measures were ;
- The researchers believe that this test is not suitable for those who participate .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Phase II Clinical Study of the Maintenance Therapy of Capecitabine Afer the XELOX in Treatment of Advanced Gastric Cancer
To confirm the efficacy and safety of XELOX with capecitabine maintenance in treatment of advanced gastric cancer (AGC)
- Conditions
- Advanced Gastric Cancer
- Being tested
- Paclitaxel, Oxaliplatin and Capecitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Oxaliplatin and CapecitabineDrug
Before randomization,all enrolled patients underwent 3 cycles XELOX chemotheray. After patients' disease achieved CR\PR\SD,then randomized into this clinical trial.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Capecitabine: 1000mg/m^2 bid, days 1-14, every 3 weeks until progression/intolerance. Receives: Drug: Paclitaxel; Drug: Oxaliplatin and Capecitabine |
| B | Placebo comparator | Observation until progression Receives: Drug: Paclitaxel; Drug: Oxaliplatin and 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 24 months
Secondary outcomes (3)
overall survival (OS)
Measured: from the date of randomization until death from any cause or up to 1 year
adverse events (AE)
Measured: from date of randomization to 28 days after the last chemo dosage
health-related quality of life (HRQOL
Measured: evaluate every 6 weeks from the date of randomization until 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 posted16 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second People's Hospital of Sichuan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chengya Chou, The Second People's Hospital of Sichuan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038621
- Sponsor's protocol ID
- 2ndSichuan
- Other IDs
- GZH-001
- Acronym
- GZH-001
- Status last verified
- Jan 2014
- First submitted
- 15 Jan 2014
- Last updated
- 16 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study of the Maintenance Therapy of Capecitabine Afer the XELOX in Treatment of Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT02038621
- Acronym / sponsor ID
- GZH-001 / 2ndSichuan
- Conditions
- Advanced Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- The Second People's Hospital of SichuanUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 16 Jan 2014 (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 advanced gastric cancer (AGC)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Paclitaxel, Drug: Oxaliplatin and CapecitabineCapecitabine: 1000mg/m^2 bid, days 1-14, every 3 weeks until progression/intolerance. |
| B | Placebo comparator | Drug: Paclitaxel, Drug: Oxaliplatin and CapecitabineObservation until progression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years old
- male or female
- Patients with stage IV gastric cancer by pathology or cytology and imaging diagnosis , or after previous surgery or radiotherapy or chemotherapy in patients with stage IV gastric cancer progression , there RECIST criteria evaluable lesions ;
- ECOG performance status score 0-2 ;
- Expected survival time more than three months ;
Key exclusion criteria (7 listed)
- For patients allergic to capecitabine ;
- Patients with CNS metastases
- Undermine the integrity of the upper gastrointestinal tract , malabsorption syndrome , or unable to take oral medication ;
- Patients with coronary heart disease , angina , myocardial infarction , arrhythmia, cerebral thrombosis, stroke and other serious cardiovascular and cerebrovascular disease ;
- Or in combination with other anti-tumor therapy in patients participating in clinical trials of other interventions ;
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 |
|---|---|---|
| Paclitaxel | Drug | A, B |
| Oxaliplatin and CapecitabineBefore randomization,all enrolled patients underwent 3 cycles XELOX chemotheray. After patients' disease achieved CR\PR\SD,then randomized into this clinical trial. | Drug | A, B |
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 24 months
3 secondary outcomes
overall survival (OS)
Time frame: from the date of randomization until death from any cause or up to 1 year
adverse events (AE)
Time frame: from date of randomization to 28 days after the last chemo dosage
health-related quality of life (HRQOL
Time frame: evaluate every 6 weeks from the date of randomization until 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 16 Jan 2014.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel and Oxaliplatin and Capecitabine in people with Advanced Gastric Cancer, run by The Second People's Hospital of Sichuan.
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 7 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 16 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Chengya Zhou, bachelor (86 13980972569, yaya713913@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 24 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 16 Jan 2014.