Gastric AdenocarcinomaPhase 2DaeMonNCT01567618
Dose-dense Biweekly Docetaxel Combined With 5-fluorouracil as First-line Treatment in Advanced Gastric Cancer
A Phase 2 study testing Docetaxel and Fluorouracil in people with Gastric Adenocarcinoma, 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 and DeGramont regimen on unresectable gastric adenocarcinoma in the first-line therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Adenocarcinoma
- What is being tested?
- Docetaxel and Fluorouracil
- Type of treatment
- Injection or infusion
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- Mar 2012to Apr 2014
- 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 80 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
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- 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.
China1 site
Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655
About this study
Official title: A Phase II Trial Evaluating Biweekly Docetaxel and DeGramont Regimen in First-Line Treatment of Unresectable or Metastatic Gastric Adenocarcinoma (DaeMon)
This is an open-label, phase II study to evaluate the efficacy and safety of biweekly docetaxel and DeGramont regimen on unresectable gastric adenocarcinoma in the first-line therapy.
Read the detailed description
Primary endpoint: Overall Response Rate
Secondary endpoint: Time to progression, overall survival, safety data
- Conditions
- Gastric Adenocarcinoma
- Being tested
- Docetaxel, Fluorouracil
- Keywords
- Docetaxel, Fluorouracil, First line therapy, Gastric cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Docetaxel 50mg/m2 iv drip, repeat every two weeks;
Efficacy will be evaluated every three cycles.
FluorouracilDrug
Fluorouracil 400mg/m2 iv D1; Fluorouracil 2400mg/m2 civ 46 hours; repeat fortnightly and evaluate every two cycles
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate according to RECIST 1.1
Measured: One Year
Secondary outcomes (3)
Time to progression
Measured: One year
Overall survival
Measured: One year
Incidence of grade 3 or 4 toxicity
The criteria to grade the toxicity is NCI CTC 3.0
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionSep 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Xiao, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567618
- Sponsor's protocol ID
- SAHMO-04
- Acronym
- DaeMon
- Status last verified
- Nov 2014
- First submitted
- 27 Mar 2012
- Last updated
- 7 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial Evaluating Biweekly Docetaxel and DeGramont Regimen in First-Line Treatment of Unresectable or Metastatic Gastric Adenocarcinoma (DaeMon)
- ClinicalTrials.gov ID
- NCT01567618
- Acronym / sponsor ID
- DaeMon / SAHMO-04
- Conditions
- Gastric Adenocarcinoma
- Keywords
- Docetaxel, Fluorouracil, First line therapy, Gastric cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 30 Mar 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.
This is an open-label, phase II study to evaluate the efficacy and safety of biweekly docetaxel and DeGramont regimen on unresectable gastric adenocarcinoma in the first-line therapy.
Detailed description
Primary endpoint: Overall Response Rate
Secondary endpoint: Time to progression, overall survival, safety data
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 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 |
|---|---|---|
| DocetaxelDocetaxel 50mg/m2 iv drip, repeat every two weeks; Efficacy will be evaluated every three cycles. | Drug | – |
| FluorouracilFluorouracil 400mg/m2 iv D1; Fluorouracil 2400mg/m2 civ 46 hours; repeat fortnightly and evaluate every two cycles | Drug | – |
Primary outcome
Overall response rate according to RECIST 1.1
Time frame: One Year
3 secondary outcomes
Time to progression
Time frame: One year
Overall survival
Time frame: One year
Incidence of grade 3 or 4 toxicity
Time frame: One year
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 7 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.
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 and Fluorouracil in people with Gastric Adenocarcinoma, 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: finished, as of the sponsor's last update on 7 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?
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?
Overall response rate according to RECIST 1.1 (time frame: One 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 7 Nov 2014.