Gastrointestinal CancerPhase 2NCT01608646
Study of DPD for Predicting Efficacy and Safety to S-1 Plus Oxaliplatin in Gastrointestinal Cancer
A Phase 2 study testing S-1 plus oxaliplatin in people with Gastrointestinal Cancer, run by Xijing Hospital at 1 site in China.
Trial summary
In this study, the relationship between DPD and the effects of S-1 combined with oxaliplatin chemotherapy were investigated in 200 patients with gastrointestinal carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancer
- What is being tested?
- S-1 plus oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Mar 2012to Aug 2018
- 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
- Age ≧18;
- Histologically or cytologically confirmed gastrointestinal cancer；
- ECOG ≦2;
- Physician's intention to treat with S-1 combined with platinum regimen on disease status and clinical judgment;
- Life expectancy of at least three months;
- Written informed consent to participate in the trial;
Who cannot join
- History of severe hypersensitivity reactions to the ingredients of S-1 or oxaliplatin;
- Inadequate hematopoietic function which is defined as below:
- white blood cell (WBC) less than 3,500/mm^3
- absolute neutrophil count (ANC) less than 1,500/mm^3
- platelets less than 80,000/mm^3
- Inadequate hepatic or renal function which is defined as below:
Show all 19Show fewer
- serum bilirubin greater than 1.5 times the upper limit of normal range
- alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
- greater than 2.5 times the ULN if no demonstrable liver metastases or
- greater than 5 times the ULN in the presence of liver metastases
- blood creatinine level greater than 2 times ULN
- Presence of peripheral neuropathy;
- Receiving a concomitant treatment with other fluoropyrimidine drug or flucytosine drug;
- Women who is pregnant or lactating or fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period (Including male);
- Psychiatric disorder or symptom that makes participation of the patient difficult;
- Concomitant illness that might be aggregated by active, non-controlled disease such as congestive heart failure, ischemic heart disease, uncontrolled hypertension or arrhythmia with in six months;
- Severe complication(s), e.g., paresis of intestines, ileus, radiographically confirmed interstitial pneumonitis or pulmonary fibrosis, glomerulonephritis ,renal failure, poorly-controlled diabetes;
- Known DPD deficiency;
- Receiving a concomitant treatment with sorivudine or Brivudine within two months;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing hospital of the fourth military medical univercity
Xijing, Shanxi, 710031
WENCHAO LIU, Professor, 029-84775407, liuch@FMMU.edu.cn
WENCHAO LIU, Professor
About this study
Official title: Study of Dihydropyrimidine Dehydrogenase for Predicting Efficacy and Safety to S-1 Plus Oxaliplatin in Gastrointestinal Cancer
In this study, the relationship between DPD and the effects of S-1 combined with oxaliplatin chemotherapy were investigated in 200 patients with gastrointestinal carcinoma.
Read the detailed description
A new oral DPD inhibitory fluoropyrimidine (DIF), S-1, is reportedly effective against gastrointestinal carcinoma. In this study, the relationship between activity of DPD in peripheral blood and the effects of chemotherapy were investigated in 200 patients treated with first-line S-1 combined with platinum chemotherapy for gastrointestinal carcinoma.
- Conditions
- Gastrointestinal Cancer
- Being tested
- S-1 plus oxaliplatin
- Keywords
- S-1, Oxaliplatin, Dihydropyrimidine Dehydrogenase
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1 plus oxaliplatinDrug
Also called TS-1 plus oxaliplatin, Teysuno plus oxaliplatin
S-1 40 mg/m2 administered orally BID after breakfast and evening meal from Day 1 through Day 14 with a single dose of oxaliplatin 130 mg/m2 will be administered as an 2-hour IV infusion following the morning dose of S-1 on Day 1. The combination therapy will be repeated every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| S-1 plus oxaliplatin | No intervention | S-1 40 mg/m2 administered orally BID after breakfast and evening meal from Day 1 through Day 14 with a single dose of oxaliplatin 130 mg/m2 will be administered as an 2-hour IV infusion following the morning dose of S-1 on Day 1. The combination therapy will be repeated every 3 weeks. Receives: Drug: S-1 plus oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective tumor response
Tumor response was evaluated by RECIST 1.1. The relationship between DPD activity and the objective tumor response will be evaluated by Cox's proportional hazards regression model.
Measured: Every eight weeks
Secondary outcomes (3)
Overall survival
The relationship between DPD activity and the overall survival will be evaluated by Cox's proportional hazards regression model.
Measured: Three year
Progress-free survival
The relationship between DPD activity and the PFS will be evaluated by Cox's proportional hazards regression model.
Measured: one year
Adverse event incidence
The relationship between DPD activity and the drug-related toxicity incidence will be evaluated by Cox's proportional hazards regression model.
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 posted31 May 2012 (estimated)
- Study startMar 2012
- Primary completionAug 2013 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- WENCHAO LIU, professor, Principal investigator, xijing hospital of the fourth military medical univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608646
- Sponsor's protocol ID
- TOTTG270105
- Status last verified
- May 2012
- First submitted
- 13 May 2012
- Last updated
- 31 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Dihydropyrimidine Dehydrogenase for Predicting Efficacy and Safety to S-1 Plus Oxaliplatin in Gastrointestinal Cancer
- ClinicalTrials.gov ID
- NCT01608646
- Acronym / sponsor ID
- TOTTG270105
- Conditions
- Gastrointestinal Cancer
- Keywords
- S-1, Oxaliplatin, Dihydropyrimidine Dehydrogenase
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 31 May 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.
In this study, the relationship between DPD and the effects of S-1 combined with oxaliplatin chemotherapy were investigated in 200 patients with gastrointestinal carcinoma.
Detailed description
A new oral DPD inhibitory fluoropyrimidine (DIF), S-1, is reportedly effective against gastrointestinal carcinoma. In this study, the relationship between activity of DPD in peripheral blood and the effects of chemotherapy were investigated in 200 patients treated with first-line S-1 combined with platinum chemotherapy for gastrointestinal carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| S-1 plus oxaliplatin | No intervention | Drug: S-1 plus oxaliplatinS-1 40 mg/m2 administered orally BID after breakfast and evening meal from Day 1 through Day 14 with a single dose of oxaliplatin 130 mg/m2 will be administered as an 2-hour IV infusion following the morning dose of S-1 on Day 1. The combination therapy will be repeated every 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≧18;
- Histologically or cytologically confirmed gastrointestinal cancer；
- ECOG ≦2;
- Physician's intention to treat with S-1 combined with platinum regimen on disease status and clinical judgment;
- Life expectancy of at least three months;
Key exclusion criteria (19 listed)
- History of severe hypersensitivity reactions to the ingredients of S-1 or oxaliplatin;
- Inadequate hematopoietic function which is defined as below:
- Inadequate hepatic or renal function which is defined as below:
- Presence of peripheral neuropathy;
- Receiving a concomitant treatment with other fluoropyrimidine drug or flucytosine drug;
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 |
|---|---|---|
| S-1 plus oxaliplatinAlso: TS-1 plus oxaliplatin, Teysuno plus oxaliplatinS-1 40 mg/m2 administered orally BID after breakfast and evening meal from Day 1 through Day 14 with a single dose of oxaliplatin 130 mg/m2 will be administered as an 2-hour IV infusion following the morning dose of S-1 on Day 1. The combination therapy will be repeated every 3 weeks. | Drug | S-1 plus oxaliplatin |
Primary outcome
Objective tumor response
Time frame: Every eight weeks
Tumor response was evaluated by RECIST 1.1. The relationship between DPD activity and the objective tumor response will be evaluated by Cox's proportional hazards regression model.
3 secondary outcomes
Overall survival
Time frame: Three year
Progress-free survival
Time frame: one year
Adverse event incidence
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2012.
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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.
WENCHAO LIU, professor principal investigator
xijing hospital of the fourth military medical univercity
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 S-1 plus oxaliplatin in people with Gastrointestinal Cancer, run by Xijing Hospital 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 6 inclusion and 19 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 31 May 2012. 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 WENCHAO LIU, Professor (029-84775407, liuch@FMMU.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective tumor response (time frame: Every eight 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 31 May 2012.