Gastric CancerPhase 3NCT01468389
Taxanes or Platinum in Combination With Capecitabine Followed by Capecitabine Alone as First Line Treatment for Patients With Advanced Adenocarcinoma of Stomach or Esophagogastric Junction
A Phase 3 study testing Capecitabine in people with Gastric Cancer, run by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences at 1 site in China.
Trial summary
The purpose of this study is to investigate whether Taxanes or Platinum Plus Capecitabine With Capecitabine Maintenance Treatment as 1st line treatment in he advanced gastric cancer is effective and safe. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Nov 2011to Jun 2013
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having signed informed consent
- Age≥ 18 years old
- Histologically confirmed gastric adenocarcinoma
- Unresectable recurrent or metastatic disease
- Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months
- Previous chemotherapy with oxaliplatin or cisplatin or paclitaxel or docetaxel, if applicable, more than 12 months.
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- Measurable disease according to the RECIST criteria
- ECOG performance status ≤2
- Life expectancy of ≥3 month
- No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
- ALT and AST≤2.5 times ULN (≤5 times ULN in patients with liver metastases) Serum albumin level ≥3.0g/dL Serum creatinine ≤1.5ULN Bilirubin level ≤ 1.5 ULN WBC>3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet>90,000/mm3, Hb>8g/dl
Who cannot join
- Brain metastasis (known or suspected)
- Previous systemic therapy for metastatic gastric cancer
- Inability to take oral medication
- Previous therapy targeting at angiogenesis or vasculogenesis pathway or other targeted therapy
- Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry
- Allergic constitution or allergic history to any investigating agents.
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- Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension.
- Pregnancy or lactation period
- Any investigational agent within the past 28 days
- Other previous malignancy within 5 year
- Pre-existing neuropathy>grade 1
- Legal incapacity
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
307 Hospital of PLA
Beijing, Beijing Municipality
Xu jianming, M.D., 86-10-66947176, jmxu2003@yahoo.com
Zhao chuanhua, 86-10-66947179, chuanhuazhao@163.com
About this study
Official title: A Randomized Multicenter Phase III Study:Taxanes or Platinum in Combination With Capecitabine Followed by Capecitabine Alone vs.Taxanes or Platinum Combined With Capecitabine in Advanced Adenocarcinoma of the Stomach or Esophagogastric Junction.
The purpose of this study is to investigate whether Taxanes or Platinum Plus Capecitabine With Capecitabine Maintenance Treatment as 1st line treatment in he advanced gastric cancer is effective and safe.
- Conditions
- Gastric Cancer
- Being tested
- Capecitabine
- Keywords
- Gastric Cancer, capecitabine, maintenance treatment
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
900-1000mg/m2 bid, days 1-14, every 3 weeks
capecitabineDrug
Dosing schedule: 900-1000mg/m2 bid, days 1-14, every 3 weeks Maintenance dosing schedule: 1000-1250mg/m2 bid, days 1-14, every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Taxanes or Platinum in combination with Capecitabine | Active comparator | The patients will received chemotherapy combining capecitabine with platinum or taxanes until progression. Receives: Drug: Capecitabine |
| chemotherapy followed by capecitabine alone | Experimental | The patients who has received 4 cycle chemotherapy combining capecitabine with platinum or taxanes and the result was SD or CR or PR,will be given capecitabine alone until progression. Receives: Drug: capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: 1 year
Secondary outcomes (4)
Tumor response rate
Measured: 1 year
disease control rate
Measured: 1 year
overall survival
Measured: 3 year
adverse events
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJan 2013 (estimated)
- Study completionJun 2013 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu jianming, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
- Investigators
- Xu jianming, M.D., Principal investigator, The Affiliated Hospital of the Chinese Academy of Military Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01468389
- Sponsor's protocol ID
- AGC001-307PLAH-XJM
- Status last verified
- Nov 2011
- First submitted
- 4 Nov 2011
- Last updated
- 10 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Multicenter Phase III Study:Taxanes or Platinum in Combination With Capecitabine Followed by Capecitabine Alone vs.Taxanes or Platinum Combined With Capecitabine in Advanced Adenocarcinoma of the Stomach or Esophagogastric Junction.
- ClinicalTrials.gov ID
- NCT01468389
- Acronym / sponsor ID
- AGC001-307PLAH-XJM
- Conditions
- Gastric Cancer
- Keywords
- Gastric Cancer, capecitabine, maintenance treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of the Chinese Academy of Military Medical SciencesUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 9 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 purpose of this study is to investigate whether Taxanes or Platinum Plus Capecitabine With Capecitabine Maintenance Treatment as 1st line treatment in he advanced gastric cancer is effective and safe.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taxanes or Platinum in combination with Capecitabine | Active comparator | Drug: CapecitabineThe patients will received chemotherapy combining capecitabine with platinum or taxanes until progression. |
| chemotherapy followed by capecitabine alone | Experimental | Drug: capecitabineThe patients who has received 4 cycle chemotherapy combining capecitabine with platinum or taxanes and the result was SD or CR or PR,will be given capecitabine alone until progression. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Having signed informed consent
- Age≥ 18 years old
- Histologically confirmed gastric adenocarcinoma
- Unresectable recurrent or metastatic disease
- Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months
Key exclusion criteria (12 listed)
- Brain metastasis (known or suspected)
- Previous systemic therapy for metastatic gastric cancer
- Inability to take oral medication
- Previous therapy targeting at angiogenesis or vasculogenesis pathway or other targeted therapy
- Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry
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 |
|---|---|---|
| Capecitabine900-1000mg/m2 bid, days 1-14, every 3 weeks | Drug | Taxanes or Platinum in combination with Capecitabine |
| capecitabineDosing schedule: 900-1000mg/m2 bid, days 1-14, every 3 weeks Maintenance dosing schedule: 1000-1250mg/m2 bid, days 1-14, every 3 weeks | Drug | chemotherapy followed by capecitabine alone |
Primary outcome
Progression free survival
Time frame: 1 year
4 secondary outcomes
Tumor response rate
Time frame: 1 year
disease control rate
Time frame: 1 year
overall survival
Time frame: 3 year
adverse events
Time frame: 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2011.
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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.
Xu jianming, M.D. principal investigator
The Affiliated Hospital of the Chinese Academy of Military Medical Science
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 Capecitabine in people with Gastric Cancer, run by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences 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 11 inclusion and 12 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 10 Nov 2011. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xu jianming, M.D. (861051128358, jmxu2003@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 1 year). 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 10 Nov 2011.