Metastatic Advanced Gastric CancerPhase 2NCT01624025
A Comparative Study of Salvage Treatment With Combination of Docetaxel and Epirubicin
A Phase 2 study testing Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks in people with Metastatic Advanced Gastric Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
A salvage treatment with combination of docetaxel and epirubicin in patients with unresectable, metastatic gastric cancer after fluoropyrimidine failure : A HER2 status-based study Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Metastatic Advanced Gastric Cancer
- What is being tested?
- Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2012to 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed metastatic, or recurrent AGC
- Previous use of fluoropyrimidine as palliative chemotherapy. Concurrent use of platinum is permitted. Patient with recurred disease within 6 months after the end of adjuvant therapy can participate to this trial.
- Documented HER2 expression status.
- Radiologically proven progression of disease.
- Age > 20 years
- ECOG PS 0 - 2
Show all 9Show fewer
- Life expectancy more than 3 months
- Adequate organ function for treatment including liver, kidney and bone marrow (absolute neutrophil count (ANC) ≥ 1,500/ul, platelets ≥ 100,000/ul, AST/ALT ≤ 2.5 x ULN, ≤ 5.0 x ULN if liver involvement, Total serum bilirubin ≤ 2.0 mg/dL)
- Written informed consent
Who cannot join
- Prior administration of taxane or anthracycline as palliative chemotherapy. If those agents were used as adjuvant or neoadjuvant aim, at least 6 months should be passed.
- Uncontrolled medical comorbidities Congestive heart failure (NYHA class III or IV) Recent (within 6 months) unstable angina or myocardial infarct Clinically significant cardiac arrhythmia LVEF < 45% Liver cirrhosis (Child-Pugh class B or C) Interstitial pneumonia Psychiatric illness/social situations that would limit compliance with study requirements
- Active CNS metastasis not controllable with radiation or steroid
- Concurrent administration of systemic chemotherapy or radiotherapy. Palliative radiotherapy for pain control more than 2 weeks ago is acceptable.
- Pregnant or lactating women.
- Peripheral neuropathy G3~4.
- Metachronous malignancy other than adequately treated CIN of uterine cervix, basal cell or squamous cell carcinoma of the skin.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University College of Medicine
Seoul, Seoul, 120-752
About this study
A salvage treatment with combination of docetaxel and epirubicin in patients with unresectable, metastatic gastric cancer after fluoropyrimidine failure : A HER2 status-based study
- Conditions
- Metastatic Advanced Gastric Cancer
- Being tested
- Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks
- Keywords
- AGC, second-line, docetaxel, epirubicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wksOther
Both the patients with HER2 (+) and HER2 (-) patients will be treated with the same regimen.
| Study group | Role | What they receive |
|---|---|---|
| HER2 positive | Experimental | Both the patients with HER2 (+) and HER2 (-) patients will be treated with the same regimen.(Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks) Receives: Other: Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks |
| HER2 negative | Active comparator | Both the patients with HER2 (+) and HER2 (-) patients will be treated with the same regimen.
(Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks) Receives: Other: Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease control rate according to the RECIST v1.1
The primary outcome of the current study is the disease control according to the HER2 status. That is, the % of the patients who maintains at least stable disease by RECIST v1.1 at the time of the second tumor evaluation which will be taken at 6~8 weeks later after the first evaluation. The comparison will be done by Pearsons's chi-square test.
Measured: at 6~8 weeks later after the first evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionSep 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Advanced Gastric CancerStudies of the same condition, open and under way.
- More trials run by Yonsei 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01624025
- Sponsor's protocol ID
- 4-2012-0222
- Status last verified
- Aug 2016
- First submitted
- 12 Jun 2012
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Salvage Treatment With Combination of Docetaxel and Epirubicin
- ClinicalTrials.gov ID
- NCT01624025
- Acronym / sponsor ID
- 4-2012-0222
- Conditions
- Metastatic Advanced Gastric Cancer
- Keywords
- AGC, second-line, docetaxel, epirubicin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 20 Jun 2012 (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.
A salvage treatment with combination of docetaxel and epirubicin in patients with unresectable, metastatic gastric cancer after fluoropyrimidine failure : A HER2 status-based study
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HER2 positive | Experimental | Other: Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wksBoth the patients with HER2 (+) and HER2 (-) patients will be treated with the same regimen.(Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks) |
| HER2 negative | Active comparator | Other: Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wksBoth the patients with HER2 (+) and HER2 (-) patients will be treated with the same regimen. (Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed metastatic, or recurrent AGC
- Previous use of fluoropyrimidine as palliative chemotherapy. Concurrent use of platinum is permitted. Patient with recurred disease within 6 months after the end of adjuvant therapy can participate to this trial.
- Documented HER2 expression status.
- Radiologically proven progression of disease.
- Age > 20 years
Key exclusion criteria (7 listed)
- Prior administration of taxane or anthracycline as palliative chemotherapy. If those agents were used as adjuvant or neoadjuvant aim, at least 6 months should be passed.
- Uncontrolled medical comorbidities Congestive heart failure (NYHA class III or IV) Recent (within 6 months) unstable angina or myocardial infarct Clinically significant cardiac arrhythmia LVEF < 45% Liver cirrhosis (Child-Pugh class B or C) Interstitial pneumonia Psychiatric illness/social situations that would limit compliance with study requirements
- Active CNS metastasis not controllable with radiation or steroid
- Concurrent administration of systemic chemotherapy or radiotherapy. Palliative radiotherapy for pain control more than 2 weeks ago is acceptable.
- Pregnant or lactating women.
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 |
|---|---|---|
| Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wksBoth the patients with HER2 (+) and HER2 (-) patients will be treated with the same regimen. | Other | HER2 negative, HER2 positive |
Primary outcome
disease control rate according to the RECIST v1.1
Time frame: at 6~8 weeks later after the first evaluation
The primary outcome of the current study is the disease control according to the HER2 status. That is, the % of the patients who maintains at least stable disease by RECIST v1.1 at the time of the second tumor evaluation which will be taken at 6~8 weeks later after the first evaluation. The comparison will be done by Pearsons's chi-square test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks in people with Metastatic Advanced Gastric Cancer, run by Yonsei University at 1 site in South Korea.
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 9 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: finished, as of the sponsor's last update on 17 Aug 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 South Korea. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
disease control rate according to the RECIST v1.1 (time frame: at 6~8 weeks later after the first evaluation). 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 17 Aug 2016.