Gastric CancerPhase 2GC-A-003NCT01980810
First Line Chemotherapy for Advanced Cancer
A Phase 2 study testing albumin-bounded paclitaxel and S-1 in people with Gastric Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The purpose of this study is to determine whether albumine-bounded paclitaxel plus S-1 are effective in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- albumin-bounded paclitaxel and S-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- Sep 2013to Feb 2016
- 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
- Inoperable locally advanced, recurrent, and/or metastatic adenocarcinoma of the stomach or gastro-esophageal junction
- Adult patients >=18 years of age
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-2;
- At least have one measurable disease(according to RECIST)
- Adequate bone marrow,renal and liver function
Who cannot join
- Previous chemotherapy for advanced/metastatic disease
- Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Medical Oncology,Cancer Hostpital and Institute,CAMS
Beijing, 100021
About this study
Official title: Pase 2 Study of Albumin-bounded Paclitaxel Plus S-1 as First-line Chemotherapy for Locally Advanced or Metastatic Gastric or Gastro-esophageal Adenocarcinoma
The purpose of this study is to determine whether albumine-bounded paclitaxel plus S-1 are effective in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma.
Read the detailed description
This phase II study was designed to evaluate the efficacy and safety of albumin-bounded paclitaxel combined with S-1 as first-line chemotherapy for inoperable and /or metastatic gastric or gastroesophageal junction cancer.Primary endpoint was overall response rate.
- Conditions
- Gastric Cancer
- Being tested
- albumin-bounded paclitaxel, S-1
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
albumin-bounded paclitaxelDrug
Also called Abraxane, Paclitaxel Albumin-stabilized Nanoparticle Formulation
200mg iv d1, repeat every 2 weeks,until disease progression,or up to 9 cycles
S-1Drug
Also called TS-1
40mg/m2 po, bid,d1-10,repeated every 2 weeks until disease progression
| Study group | Role | What they receive |
|---|---|---|
| albumin-bounded paclitaxel plus S-1 | Experimental | arm 1:albumin-bounded paclitaxel 200mg iv d1 and S-1 80mg/m2/d po d1-10, repeated every 2 weeks,up to 9 cycles,then S-1 as single agent to treat to disease progression Receives: Drug: albumin-bounded paclitaxel; Drug: S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
Measured: 12 weeks
Secondary outcomes (3)
progression free survival
Measured: 1 year
overall survival
Measured: 1 year
number of adverse event
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startSep 2013
- Primary completionFeb 2015
- Study completionFeb 2016
Why it stopped: recruit too slowly
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Yang, Chinese Academy of Medical Sciences
- Investigators
- Lin Yang, MD, Principal investigator, Department of medical oncology,Cancer hospital and institute,CAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980810
- Sponsor's protocol ID
- CH-GI-037-nab
- Acronym
- GC-A-003
- Status last verified
- Jun 2016
- First submitted
- 5 Nov 2013
- Last updated
- 14 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pase 2 Study of Albumin-bounded Paclitaxel Plus S-1 as First-line Chemotherapy for Locally Advanced or Metastatic Gastric or Gastro-esophageal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT01980810
- Acronym / sponsor ID
- GC-A-003 / CH-GI-037-nab
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruit too slowly
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 11 Nov 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.
The purpose of this study is to determine whether albumine-bounded paclitaxel plus S-1 are effective in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma.
Detailed description
This phase II study was designed to evaluate the efficacy and safety of albumin-bounded paclitaxel combined with S-1 as first-line chemotherapy for inoperable and /or metastatic gastric or gastroesophageal junction cancer.Primary endpoint was overall response rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| albumin-bounded paclitaxel plus S-1 | Experimental | Drug: albumin-bounded paclitaxel, Drug: S-1arm 1:albumin-bounded paclitaxel 200mg iv d1 and S-1 80mg/m2/d po d1-10, repeated every 2 weeks,up to 9 cycles,then S-1 as single agent to treat to disease progression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Inoperable locally advanced, recurrent, and/or metastatic adenocarcinoma of the stomach or gastro-esophageal junction
- Adult patients >=18 years of age
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-2;
- At least have one measurable disease(according to RECIST)
- Adequate bone marrow,renal and liver function
Key exclusion criteria (2 listed)
- Previous chemotherapy for advanced/metastatic disease
- Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome
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 |
|---|---|---|
| albumin-bounded paclitaxelAlso: Abraxane, Paclitaxel Albumin-stabilized Nanoparticle Formulation200mg iv d1, repeat every 2 weeks,until disease progression,or up to 9 cycles | Drug | albumin-bounded paclitaxel plus S-1 |
| S-1Also: TS-140mg/m2 po, bid,d1-10,repeated every 2 weeks until disease progression | Drug | albumin-bounded paclitaxel plus S-1 |
Primary outcome
response rate
Time frame: 12 weeks
3 secondary outcomes
progression free survival
Time frame: 1 year
overall survival
Time frame: 1 year
number of adverse event
Time frame: 1 year
Results and safety
The study was stopped early (reason given: recruit too slowly). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2016.
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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 Yang, MD principal investigator
Department of medical oncology,Cancer hospital and institute,CAMS
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 albumin-bounded paclitaxel and S-1 in people with Gastric Cancer, run by Chinese Academy of 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 5 inclusion and 2 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: stopped early, as of the sponsor's last update on 14 Jun 2016. 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?
The study was stopped early (reason given: recruit too slowly). Results are not available in the source record.
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?
response rate (time frame: 12 weeks). 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 14 Jun 2016.