Advanced Gastric CancerPhase 3NCT01015339
Paclitaxel Plus Capecitabine With Capecitabine Maintenance Treatment in Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction
A Phase 3 study testing Paclitaxel, capecitabine and cisplatin in people with Advanced Gastric Cancer, run by Peking University at 1 site in China.
Trial summary
The purpose of this study is to investigate whether Paclitaxel 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 years and older
- Conditions the study is for
- Advanced Gastric Cancer
- What is being tested?
- Paclitaxel, capecitabine and cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- Nov 2009to Aug 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 18 years and older
- 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 capecitabine or cisplatin, if applicable, more than 12 months.
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- Measurable disease according to the RECIST criteria
- Karnofsky performance status ≥60
- Life expectancy of ≥2 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 AKP < 2.5 times ULN
- Serum creatinine <ULN, and CCr < 60ml/min
- Bilirubin level < 1.5 ULN
- WBC>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet>100,000/mm3, Hb>9g/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
- Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on.
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- Allergic constitution or allergic history to protium biologic product or any investigating agents.
- 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, except non-melanoma skin cancer
- Previous adjuvant therapy with capecitabine+platinum,
- Pre-existing neuropathy>grade 1
- Legal incapacity
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of GI Oncology, Peking University, School of Oncology
Beijing, Beijing Municipality, 100142
Zhihao Lu, MD, 86-10-88196561, pppeirain@126.com
Shen Lin, MD
About this study
Official title: A Randomized Multicenter Phase III Study Comparing Paclitaxel Plus Capecitabine With Capecitabine Maintenance Treatment or Cisplatin Plus Capecitabine in Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction
The purpose of this study is to investigate whether Paclitaxel Plus Capecitabine With Capecitabine Maintenance Treatment as 1st line treatment in he advanced gastric cancer is effective and safe.
- Conditions
- Advanced Gastric Cancer
- Being tested
- Paclitaxel, capecitabine, cisplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
80mg/m2 infusion,d1,d8 every 3 weeks
capecitabineDrug
Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks
capecitabineDrug
Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks
cisplatinDrug
80mg/m2, day 1 of every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin plus capecitabine | Active comparator | Not described Receives: Drug: capecitabine; Drug: cisplatin |
| Paclitaxel plus Capecitabine | Experimental | Not described Receives: Drug: Paclitaxel; Drug: capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: 3 year
Secondary outcomes (4)
Tumor response rate
Measured: 1 year
Disease control rate
Measured: 1 year
Overall survival
Measured: 5 year
adverse evens
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (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.
- More trials run by Peking UniversityThe 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
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Principal investigator, Shen Lin, Peking University
- Investigators
- Lin Shen, MD, Principal investigator, Peking University, School of oncology, Department of GI oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015339
- Sponsor's protocol ID
- PAC-C
- Other IDs
- ML22697
- Status last verified
- May 2015
- First submitted
- 17 Nov 2009
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Multicenter Phase III Study Comparing Paclitaxel Plus Capecitabine With Capecitabine Maintenance Treatment or Cisplatin Plus Capecitabine in Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction
- ClinicalTrials.gov ID
- NCT01015339
- Acronym / sponsor ID
- PAC-C
- Conditions
- Advanced Gastric Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Nov 2009
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 18 Nov 2009 (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 Paclitaxel 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 |
|---|---|---|
| Cisplatin plus capecitabine | Active comparator | Drug: capecitabine, Drug: cisplatin |
| Paclitaxel plus Capecitabine | Experimental | Drug: Paclitaxel, Drug: capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 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 (14 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 |
|---|---|---|
| Paclitaxel80mg/m2 infusion,d1,d8 every 3 weeks | Drug | Paclitaxel plus Capecitabine |
| capecitabineDosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks | Drug | Paclitaxel plus Capecitabine |
| capecitabineDosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks | Drug | Cisplatin plus capecitabine |
| cisplatin80mg/m2, day 1 of every 3 weeks | Drug | Cisplatin plus capecitabine |
Primary outcome
Progression free survival
Time frame: 3 year
4 secondary outcomes
Tumor response rate
Time frame: 1 year
Disease control rate
Time frame: 1 year
Overall survival
Time frame: 5 year
adverse evens
Time frame: 5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2015.
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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.
Lin Shen, MD principal investigator
Peking University, School of oncology, Department of GI oncology
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 Paclitaxel, capecitabine and cisplatin in people with Advanced Gastric Cancer, run by Peking 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 16 inclusion and 14 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 19 May 2015. 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 Zhihao Lu, MD (86-10-88196561, pppeirain@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 (time frame: 3 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 19 May 2015.