Docetaxel, Oxaliplatin and FluorouracilPhase 2DaeMon-PlusNCT02289378
Dose-dense Biweekly Docetaxel, Oxaliplatin and 5-fluorouracil as First-line Treatment in Advanced Gastric Cancer
A Phase 2 study testing Docetaxel, Oxaliplatin and 5-Fu in people with Docetaxel, Oxaliplatin and Fluorouracil, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
This is an open-label, phase II study to evaluate the efficacy and safety of biweekly docetaxel, Oxaliplatin and de Gramont regimen on unresectable gastric adenocarcinoma in the first-line therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Docetaxel, Oxaliplatin and Fluorouracil
- What is being tested?
- Docetaxel, Oxaliplatin and 5-Fu
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Nov 2014to Oct 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent
- Patients with histologically or cytologically confirmed unresectable gastric adenocarcinoma whose ECOG performance status are 0-2
- Presence of measurable disease by radiographic study (including CT or MRI scan, or chest x-ray) or physical examination
- At least 3 weeks since last major surgery
- At least 12 months since last adjuvant chemotherapy
- At least 6 weeks since prior radiotherapy providing that the extent and site of radiotherapy fields are such that marked bone marrow suppression is NOT expected
Show all 11Show fewer
- Patients who have received palliative radiotherapy must have recovered from any reversible toxic effects e.g. nausea and vomiting caused by radiation of fields
- Patients with reproductive potential must use effective BC
- Required Screening Laboratory Criteria:
- Hemoglobin 90g/L WBC 3.5 x 109/L Neutrophils 1.5 x 109/L Platelets 100 x 109/L Creatinine 133 umol/L and creatinine clearance 60 mL/min
- A probable life expectancy of at least 6 months
Who cannot join
- Brain metastases
- Female of childbearing potential, pregnancy test is positive
- Concomitant malignancies or previous malignancies other than gastric cancer within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or low grade prostate cancer
- Active infection
- Concurrent severe medical problems unrelated to the malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk
- Sexually active patients refusing to practice adequate contraception; Patients with conditions which might affect absorption of an oral drug (for example intermittent obstruction) unless discussed and agreed with principal investigator
- History of grade 3 or 4 toxicity to fluoropyrimidines
Trial locations and contacts
1 site in 1 country.
Jian Xiao, MD contact
Yonghe Chen, MD contact
China1 site, 1 recruiting
- Recruiting
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655
Jian Xiao, Ph D, 86-2038250745, xiao_jian@139.com
Ping Lan, Ph D
About this study
This is an open-label, phase II study to evaluate the efficacy and safety of biweekly docetaxel, Oxaliplatin and de Gramont regimen on unresectable gastric adenocarcinoma in the first-line therapy.
Read the detailed description
Docetaxel 50mg/m2 Oxaliplatin 85mg/m2 5-Fu 2800mg/m2 Repeated every two weeks
- Conditions
- Docetaxel, Oxaliplatin and Fluorouracil
- Being tested
- Docetaxel, Oxaliplatin and 5-Fu
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel, Oxaliplatin and 5-FuDrug
To investigate the triplet regimen in the first-line therapy of advanced chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel, Oxaliplatin and 5-Fu | Experimental | Docetaxel 50mg/m2 Oxaliplatin 85mg/m2 5-Fu 2800mg/m2 Repeated every two weeks Receives: Drug: Docetaxel, Oxaliplatin and 5-Fu |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: 2 years
Secondary outcomes (1)
Response rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionOct 2016 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Docetaxel, Oxaliplatin and FluorouracilStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lan Ping, Sixth Affiliated Hospital, Sun Yat-sen University
- Investigators
- Ping Lan, MD, Study chair, The Sixth Affilated Hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02289378
- Sponsor's protocol ID
- DaeMon Plus
- Acronym
- DaeMon-Plus
- Status last verified
- Nov 2014
- First submitted
- 7 Nov 2014
- Last updated
- 14 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-dense Biweekly Docetaxel, Oxaliplatin and 5-fluorouracil as First-line Treatment in Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT02289378
- Acronym / sponsor ID
- DaeMon-Plus / DaeMon Plus
- Conditions
- Docetaxel, Oxaliplatin and Fluorouracil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 13 Nov 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.
This is an open-label, phase II study to evaluate the efficacy and safety of biweekly docetaxel, Oxaliplatin and de Gramont regimen on unresectable gastric adenocarcinoma in the first-line therapy.
Detailed description
Docetaxel 50mg/m2 Oxaliplatin 85mg/m2 5-Fu 2800mg/m2 Repeated every two weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Docetaxel, Oxaliplatin and 5-Fu | Experimental | Drug: Docetaxel, Oxaliplatin and 5-FuDocetaxel 50mg/m2 Oxaliplatin 85mg/m2 5-Fu 2800mg/m2 Repeated every two weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed written informed consent
- Patients with histologically or cytologically confirmed unresectable gastric adenocarcinoma whose ECOG performance status are 0-2
- Presence of measurable disease by radiographic study (including CT or MRI scan, or chest x-ray) or physical examination
- At least 3 weeks since last major surgery
- At least 12 months since last adjuvant chemotherapy
Key exclusion criteria (7 listed)
- Brain metastases
- Female of childbearing potential, pregnancy test is positive
- Concomitant malignancies or previous malignancies other than gastric cancer within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or low grade prostate cancer
- Active infection
- Concurrent severe medical problems unrelated to the malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk
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, Oxaliplatin and 5-FuTo investigate the triplet regimen in the first-line therapy of advanced chemotherapy | Drug | Docetaxel, Oxaliplatin and 5-Fu |
Primary outcome
Progression-free survival
Time frame: 2 years
1 secondary outcome
Response rate
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 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.
Jian Xiao, MD contact
Yonghe Chen, MD contact
Ping Lan, MD study chair
The Sixth Affilated Hospital of Sun Yat-sen University
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, Oxaliplatin and 5-Fu in people with Docetaxel, Oxaliplatin and Fluorouracil, run by Sixth Affiliated Hospital, Sun Yat-sen 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 11 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 14 Nov 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian Xiao, MD (xiao_jian@139.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: 2 years). 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 Nov 2014.