Pancreatic Ductal AdenocarcinomaPhase 2NCT03316326
S-1, Irinotecan, and Oxaliplatin in Locally-Advanced Pancreatic Cancer
A Phase 2 study testing Tegafur-gimeracil-oteracil potassium, Oxaliplatin and Irinotecan in people with Pancreatic Ductal Adenocarcinoma, run by National Taiwan University Hospital.
Trial summary
This phase II clinical trial will enroll patients with newly-diagnosed locally-advanced pancreatic adenocarcinoma and adopt the Simon's two-stage optimum design. After 4 cycles of SIROX regimen, patients will proceed to curative resection. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Tegafur-gimeracil-oteracil potassium, Oxaliplatin and Irinotecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2017to 31 Dec 2021
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically or cytologically proven pancreatic adenocarcinoma
- newly diagnosed, unresectable, locally-advanced pancreatic cancer
- no potential of R0 resection at diagnosis
- presence of measurable pancreatic lesion, which must meet the criteria of being ≥ 10 mm in at least one dimension by conventional CT/MRI
- age between 20 and 79 years at registration
- ECOG performance status (PS) of 0 or 1
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- adequate major organ functions
- ability to take the oral study medication (S-1)
- no clinically significant abnormal ECG findings within 28 days (4 weeks) prior to registration
- voluntarily signed the written informed consent form
Who cannot join
- pulmonary fibrosis or interstitial pneumonitis diagnosed within 28 days prior to registration
- presence of diarrhea ≥ CTCAE v.4.03 grade 2
- concomitant active infection
- significant co-morbid medical conditions, including, but not limited to , heart failure, renal failure, hepatic failure, hemorrhagic peptic ulcer, mechanical or paralytic ileus, or poorly controlled diabetes
- moderate or severe ascites or pleural effusion that requires drainage
- prior or concurrent malignancies within the last 3 years, with the exception of carcinoma in situ of the cervix, or basal type skin cancer
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- concomitant treatment with flucytosine, phenytoin or warfarin
- peripheral neuropathy grade of 2 or higher
- known Gilbert syndrome or homozygosity for UGT1A1 promoter TA repeats prone to high risk of drug toxicity (screening of UGT1A1 genotype will NOT performed routinely before study)
- pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential. Patients of childbearing age should have effective contraception for both the patient and his or her partners during the study period
- severe mental disorder
- judged ineligible by physician for participation in the study due to safety concern
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase II Study of S-1, Irinotecan, and Oxaliplatin in Locally-Advanced Pancreatic Cancer (SIROX Study) - Followed by Curative Surgery and Adjuvant Chemotherapy
This phase II clinical trial will enroll patients with newly-diagnosed locally-advanced pancreatic adenocarcinoma and adopt the Simon's two-stage optimum design. After 4 cycles of SIROX regimen, patients will proceed to curative resection.
Read the detailed description
This phase II clinical trial will enroll patients with newly-diagnosed locally-advanced pancreatic adenocarcinoma and adopt the Simon's two-stage optimum design. After 4 cycles of SIROX regimen, patients will proceed to curative resection. The primary endpoint of this study is resection rate after neoadjuvant chemotherapy. The first stage will enroll 18 patients. We will go into the second stage if at least 2 patients in stage I become resectable after treatment. There will be at most 35 patients enrolled. Based on this trial, we anticipate that the SIROX regimen has comparable response rate and resection rate but lower toxicities comparing to FOLFIRINOX.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- Tegafur-gimeracil-oteracil potassium, Oxaliplatin, Irinotecan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tegafur-gimeracil-oteracil potassiumDrug
Also called TS-1, S-1
40 mg bid, D1-14
OxaliplatinDrug
Also called Oxalip
85 mg/m2, D1
IrinotecanDrug
Also called Irino
150 mg/m2, D8
| Study group | Role | What they receive |
|---|---|---|
| SIROX | Experimental | Tegafur-gimeracil-oteracil potassium, irinotecan, oxaliplatin combination Receives: Drug: Tegafur-gimeracil-oteracil potassium; Drug: Oxaliplatin; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
resection rate
patients with R0 or R1 resection of the primary tumor after study chemotherapy/patients receiving at least one dose of study chemotherapy
Measured: 3 years
Secondary outcomes (2)
response rate (RR)
RR of SIROX
Measured: 3 years
Overall survival (OS)
OS of all patients
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start1 Nov 2017 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Model description
- Simon's two-stage optimum design
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- TTY Biopharm
- Responsible party
- Sponsor
- Investigators
- Yu-Wen Tien, M.D., Ph. D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316326
- Sponsor's protocol ID
- 201610076MIPB
- Status last verified
- Oct 2017
- First submitted
- 16 Oct 2017
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of S-1, Irinotecan, and Oxaliplatin in Locally-Advanced Pancreatic Cancer (SIROX Study) - Followed by Curative Surgery and Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT03316326
- Acronym / sponsor ID
- 201610076MIPB
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- TTY Biopharm
- Study start
- 1 Nov 2017 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 20 Oct 2017 (actual)
- 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 phase II clinical trial will enroll patients with newly-diagnosed locally-advanced pancreatic adenocarcinoma and adopt the Simon's two-stage optimum design. After 4 cycles of SIROX regimen, patients will proceed to curative resection.
Detailed description
This phase II clinical trial will enroll patients with newly-diagnosed locally-advanced pancreatic adenocarcinoma and adopt the Simon's two-stage optimum design. After 4 cycles of SIROX regimen, patients will proceed to curative resection. The primary endpoint of this study is resection rate after neoadjuvant chemotherapy. The first stage will enroll 18 patients. We will go into the second stage if at least 2 patients in stage I become resectable after treatment. There will be at most 35 patients enrolled. Based on this trial, we anticipate that the SIROX regimen has comparable response rate and resection rate but lower toxicities comparing to FOLFIRINOX.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Simon's two-stage optimum design
| Arm | Type | Receives |
|---|---|---|
| SIROX | Experimental | Drug: Tegafur-gimeracil-oteracil potassium, Drug: Oxaliplatin, Drug: IrinotecanTegafur-gimeracil-oteracil potassium, irinotecan, oxaliplatin combination |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- histologically or cytologically proven pancreatic adenocarcinoma
- newly diagnosed, unresectable, locally-advanced pancreatic cancer
- no potential of R0 resection at diagnosis
- presence of measurable pancreatic lesion, which must meet the criteria of being ≥ 10 mm in at least one dimension by conventional CT/MRI
- age between 20 and 79 years at registration
Key exclusion criteria (12 listed)
- pulmonary fibrosis or interstitial pneumonitis diagnosed within 28 days prior to registration
- presence of diarrhea ≥ CTCAE v.4.03 grade 2
- concomitant active infection
- significant co-morbid medical conditions, including, but not limited to , heart failure, renal failure, hepatic failure, hemorrhagic peptic ulcer, mechanical or paralytic ileus, or poorly controlled diabetes
- moderate or severe ascites or pleural effusion that requires drainage
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 |
|---|---|---|
| Tegafur-gimeracil-oteracil potassiumAlso: TS-1, S-140 mg bid, D1-14 | Drug | SIROX |
| OxaliplatinAlso: Oxalip85 mg/m2, D1 | Drug | SIROX |
| IrinotecanAlso: Irino150 mg/m2, D8 | Drug | SIROX |
Primary outcome
resection rate
Time frame: 3 years
patients with R0 or R1 resection of the primary tumor after study chemotherapy/patients receiving at least one dose of study chemotherapy
2 secondary outcomes
response rate (RR)
Time frame: 3 years
Overall survival (OS)
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
- 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.
Yu-Wen Tien, M.D., Ph. D. principal investigator
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tegafur-gimeracil-oteracil potassium, Oxaliplatin and Irinotecan in people with Pancreatic Ductal Adenocarcinoma, run by National Taiwan University Hospital.
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 10 inclusion and 12 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 20 Oct 2017. 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.
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 Shih-Hung Yang, M.D. (+886-2-23123456 ext. 66117, 018500@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
resection rate (time frame: 3 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 20 Oct 2017.