- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03316326
S-1, Irinotecan, and Oxaliplatin in Locally-Advanced Pancreatic Cancer
October 19, 2017 updated by: National Taiwan University Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
35
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shih-Hung Yang, M.D.
- Phone Number: 66117 +886-2-23123456
- Email: 018500@ntuh.gov.tw
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SIROX
Tegafur-gimeracil-oteracil potassium, irinotecan, oxaliplatin combination
|
40 mg bid, D1-14
Other Names:
85 mg/m2, D1
Other Names:
150 mg/m2, D8
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
response rate (RR)
Time Frame: 3 years
|
RR of SIROX
|
3 years
|
Overall survival (OS)
Time Frame: 4 years
|
OS of all patients
|
4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Yu-Wen Tien, M.D., Ph. D., National Taiwan University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 1, 2017
Primary Completion (Anticipated)
December 31, 2021
Study Completion (Anticipated)
December 31, 2021
Study Registration Dates
First Submitted
October 16, 2017
First Submitted That Met QC Criteria
October 19, 2017
First Posted (Actual)
October 20, 2017
Study Record Updates
Last Update Posted (Actual)
October 20, 2017
Last Update Submitted That Met QC Criteria
October 19, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201610076MIPB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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