S-1, Irinotecan, and Oxaliplatin in Locally-Advanced Pancreatic Cancer

NCT03316326 | Unknown Phase 2

• 1 other identifier: 201610076MIPB
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• resection rate

  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 Outcomes (2)

• response rate (RR)

  3 years

• Overall survival (OS)

  4 years

Study Arms (1)

SIROX

EXPERIMENTAL

Tegafur-gimeracil-oteracil potassium, irinotecan, oxaliplatin combination

Drug: Tegafur-gimeracil-oteracil potassium; Drug: Oxaliplatin; Drug: Irinotecan

Interventions

Tegafur-gimeracil-oteracil potassium DRUG

40 mg bid, D1-14

Also known as: TS-1, S-1

SIROX

Oxaliplatin DRUG

85 mg/m2, D1

Also known as: Oxalip

SIROX

Irinotecan DRUG

150 mg/m2, D8

Also known as: Irino

SIROX

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• TTY Biopharm: collaborator

MeSH Terms

Interventions

titanium silicide; S 1 (combination); Oxaliplatin; Irinotecan

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Yu-Wen Tien, M.D., Ph. D.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shih-Hung Yang, M.D.

CONTACT

+886-2-23123456; 018500@ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Simon's two-stage optimum design

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: October 20, 2017
• Study Start: November 1, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: October 20, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share