Pancreatic CancerSLOWDOSE001NCT02685228
Decitabine Combined With Gemcitabine in First-line Treatment of AdvancedPancreatic Cancer
A study testing Decitabine and Gemcitabine in people with Pancreatic Cancer, run by The First Hospital of Jilin University.
Trial summary
The purpose of this study is to investigate the effect of very low dose decitabine combinate with gemcitabine in the first-line treatment of locally advanced, unresectable and metastatic pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Decitabine and Gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Dec 2018
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histology or cytology proved to be a local development, non excision or metastatic pancreatic cancer patients. Or clinical compliance, but the pathological specimens were difficult, can be fully communicated with patients, selected clinical research.
- in the treatment of advanced cancer with no anti tumor drug.
- the damage had been recovered by other treatments, in which patients received surgery for more than 2 weeks.
- aged 18-70 years
- the physical condition ECOG score (PS) is 0-1
- the expected survival time is greater than or equal to 12 weeks
Show all 11Show fewer
- according to RECIST standard 1.1 there is at least one measurable lesion, and the lesion is irradiated with at least one measurable lesion. Any of the following methods can accurately measure the diameter of the lesions, the abdominal computed tomography CT or MRI, the conventional method of diameter of at least 20mm or the application of spiral CT diameter at least 10mm.
- the main organ function is normal, that is, in line with the following standards:(1) blood examination standard should meet: HB than 90g/L (without blood transfusion within 14 days), ANC = 1.5 * 109/L; PLT = 100 * 109/L.(2) biochemical examination must meet the following criteria: serum bilirubin is less than or equal to 1.5 times the upper limit of normal value, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) is less than or equal to 2.5 times the upper limit of the normal value of (if have hepatic metastasis allows ast, ALT is less than or equal to five times the upper limit of normal value). Serum creatinine was 1.5 times the upper limit of the normal value; creatinine clearance rate was 50mL/min.
- women of childbearing age must have a pregnancy test (serum or urine) within 7 days of entry, and the results are negative, and are willing to use appropriate methods of contraception within 8 weeks of the trial period and the last administered drugs. For men, must be agreed during the test and 8 weeks after administration of the test drug use contraceptive methods or surgical sterilization is appropriate.
- patients with good compliance.
- patients understand and voluntarily sign written informed consent.
Who cannot join
- the current or previous diagnosis of pancreatic cancer had no systemic anticancer therapy, including cytotoxic drug therapy, target to drug treatment, test treatment, auxiliary chemotherapy or neoadjuvant chemotherapy patients (but stopping for more than 6 months postoperative recurrence patients can be selected).
- patients with no measurable lesions, such as malignant pleural effusion and ascites, lymph node metastasis, bone metastasis, and brain spinal cord membrane.
- any effect on the patient's intravenous injection, and any effect on the absorption of the drug or the pharmacokinetic parameters of the drug.
- patients with systemic disease (such as unstable or non compensatory respiratory, cardiac, liver or kidney disease) with severe or no control. Any unstable systemic disease (including active infection, grade four hypertension, unstable angina, congestive heart failure, liver and kidney, or metabolic disease). Any other malignant tumor in the five years (except for the complete cure of cervical carcinoma in situ or basal cell or squamous cell skin cancer). There is a history of clear neurological or mental disorders, including epilepsy or dementia.
- patients with the functional level of the various organs of the functional level of the existence of any other important clinical abnormalities or laboratory results so that patients do not fit to participate in the study of evidence. According to the National Cancer Institute common chemotherapy toxicity grading standards (NCI-CTC, 4 edition) has more than 2 levels of chronic toxicity (not including hair loss) not cured.
- known any severe allergic components of decitabine, gemcitabine.
- previous studies have been registered for the treatment of this study, or from the patients in this study were unable to enter the group.
- pregnancy or lactation women. 9) the researchers believe that the subjects may not be able to complete the study or may not be able to comply with the requirements of this study (as a result of management reasons or other reasons).
About this study
Official title: Clinical Study of Low Dose of Decitabine Combined With Gemcitabine in First-line Treatment of Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
The purpose of this study is to investigate the effect of very low dose decitabine combinate with gemcitabine in the first-line treatment of locally advanced, unresectable and metastatic pancreatic cancer.
Read the detailed description
This study intends to advanced pancreatic cancer with row standard with district group random way is divided into two groups, a group for the gemcitabine monotherapy in the treatment group, another group of gemcitabine combined with low dose of decitabine treatment group. The overall survival, progression free survival, and disease control rate were observed in patients treated with combined therapy. At the same time, its safety and tolerance were observed. The methylation status and its influence on the immune function were also detected by biological test.
- Conditions
- Pancreatic Cancer
- Being tested
- Decitabine, Gemcitabine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DecitabineDrug
decitabine 5mg/m2,d1-d5;
GemcitabineDrug
gemcitabine 1.0g/m2, d8,d15,d22
| Study group | Role | What they receive |
|---|---|---|
| decitabine & gemcitabine | Experimental | This group was treated by low dose decitabine combinated with gemcitabine regimen. decitabine: 5mg/m2 d1-d5; gemcitabine: 1.0g/m2,d8,d15,d22. 28days for one cycle.
every 28days for one cycle Receives: Drug: Decitabine; Drug: Gemcitabine |
| gemcitabine | Active comparator | This group was treated by gemcitabine only. Gemcitabine: 1.0g/m2, d8,d15,d22; 28 days for one cycle. every 28days for one cycle Receives: Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 24 months
Secondary outcomes (1)
Evidence of the size of the lesion in pancreas confirmed by non-investigational CT or MRI
Measured: within every 28 days(plus or minus 3 days) ,up to 36 days. From date of randomization until the date of death from any cause, assessed up to 50 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02685228
- Sponsor's protocol ID
- SLOWDOSE001
- Acronym
- SLOWDOSE001
- Status last verified
- Feb 2016
- First submitted
- 1 Feb 2016
- Last updated
- 18 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Low Dose of Decitabine Combined With Gemcitabine in First-line Treatment of Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02685228
- Acronym / sponsor ID
- SLOWDOSE001 / SLOWDOSE001
- Conditions
- Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 18 Feb 2016 (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 the effect of very low dose decitabine combinate with gemcitabine in the first-line treatment of locally advanced, unresectable and metastatic pancreatic cancer.
Detailed description
This study intends to advanced pancreatic cancer with row standard with district group random way is divided into two groups, a group for the gemcitabine monotherapy in the treatment group, another group of gemcitabine combined with low dose of decitabine treatment group. The overall survival, progression free survival, and disease control rate were observed in patients treated with combined therapy. At the same time, its safety and tolerance were observed. The methylation status and its influence on the immune function were also detected by biological test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| decitabine & gemcitabine | Experimental | Drug: Decitabine, Drug: GemcitabineThis group was treated by low dose decitabine combinated with gemcitabine regimen. decitabine: 5mg/m2 d1-d5; gemcitabine: 1.0g/m2,d8,d15,d22. 28days for one cycle. every 28days for one cycle |
| gemcitabine | Active comparator | Drug: GemcitabineThis group was treated by gemcitabine only. Gemcitabine: 1.0g/m2, d8,d15,d22; 28 days for one cycle. every 28days for one cycle |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- histology or cytology proved to be a local development, non excision or metastatic pancreatic cancer patients. Or clinical compliance, but the pathological specimens were difficult, can be fully communicated with patients, selected clinical research.
- in the treatment of advanced cancer with no anti tumor drug.
- the damage had been recovered by other treatments, in which patients received surgery for more than 2 weeks.
- aged 18-70 years
- the physical condition ECOG score (PS) is 0-1
Key exclusion criteria (8 listed)
- the current or previous diagnosis of pancreatic cancer had no systemic anticancer therapy, including cytotoxic drug therapy, target to drug treatment, test treatment, auxiliary chemotherapy or neoadjuvant chemotherapy patients (but stopping for more than 6 months postoperative recurrence patients can be selected).
- patients with no measurable lesions, such as malignant pleural effusion and ascites, lymph node metastasis, bone metastasis, and brain spinal cord membrane.
- any effect on the patient's intravenous injection, and any effect on the absorption of the drug or the pharmacokinetic parameters of the drug.
- patients with systemic disease (such as unstable or non compensatory respiratory, cardiac, liver or kidney disease) with severe or no control. Any unstable systemic disease (including active infection, grade four hypertension, unstable angina, congestive heart failure, liver and kidney, or metabolic disease). Any other malignant tumor in the five years (except for the complete cure of cervical carcinoma in situ or basal cell or squamous cell skin cancer). There is a history of clear neurological or mental disorders, including epilepsy or dementia.
- patients with the functional level of the various organs of the functional level of the existence of any other important clinical abnormalities or laboratory results so that patients do not fit to participate in the study of evidence. According to the National Cancer Institute common chemotherapy toxicity grading standards (NCI-CTC, 4 edition) has more than 2 levels of chronic toxicity (not including hair loss) not cured.
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 |
|---|---|---|
| Decitabinedecitabine 5mg/m2,d1-d5; | Drug | decitabine & gemcitabine |
| Gemcitabinegemcitabine 1.0g/m2, d8,d15,d22 | Drug | decitabine & gemcitabine, gemcitabine |
Primary outcome
overall survival
Time frame: 24 months
1 secondary outcome
Evidence of the size of the lesion in pancreas confirmed by non-investigational CT or MRI
Time frame: within every 28 days(plus or minus 3 days) ,up to 36 days. From date of randomization until the date of death from any cause, assessed up to 50 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Decitabine and Gemcitabine in people with Pancreatic Cancer, run by The First Hospital of Jilin University.
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 8 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 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
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 survival (time frame: 24 months). 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 18 Feb 2016.