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

NCT ID: NCT03316326

Last Updated: 2017-10-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2021-12-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SIROX

Tegafur-gimeracil-oteracil potassium, irinotecan, oxaliplatin combination

Group Type: EXPERIMENTAL

Tegafur-gimeracil-oteracil potassium

Intervention Type: DRUG

40 mg bid, D1-14

Oxaliplatin

Intervention Type: DRUG

85 mg/m2, D1

Irinotecan

Intervention Type: DRUG

150 mg/m2, D8

Interventions

Tegafur-gimeracil-oteracil potassium

40 mg bid, D1-14

Intervention Type: DRUG

Oxaliplatin

85 mg/m2, D1

Intervention Type: DRUG

Irinotecan

150 mg/m2, D8

Intervention Type: DRUG

Other Intervention Names

TS-1; S-1; Oxalip; Irino

Eligibility Criteria

Inclusion Criteria

1. histologically or cytologically proven pancreatic adenocarcinoma

2. newly diagnosed, unresectable, locally-advanced pancreatic cancer

3. no potential of R0 resection at diagnosis

4. presence of measurable pancreatic lesion, which must meet the criteria of being ≥ 10 mm in at least one dimension by conventional CT/MRI

5. age between 20 and 79 years at registration

6. ECOG performance status (PS) of 0 or 1

7. adequate major organ functions

8. ability to take the oral study medication (S-1)

9. no clinically significant abnormal ECG findings within 28 days (4 weeks) prior to registration

10. voluntarily signed the written informed consent form

Exclusion Criteria

1. pulmonary fibrosis or interstitial pneumonitis diagnosed within 28 days prior to registration

2. presence of diarrhea ≥ CTCAE v.4.03 grade 2

3. concomitant active infection

4. 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

5. moderate or severe ascites or pleural effusion that requires drainage

6. prior or concurrent malignancies within the last 3 years, with the exception of carcinoma in situ of the cervix, or basal type skin cancer

7. concomitant treatment with flucytosine, phenytoin or warfarin

8. peripheral neuropathy grade of 2 or higher

9. 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)

10. 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

11. severe mental disorder

12. judged ineligible by physician for participation in the study due to safety concern

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TTY Biopharm

INDUSTRY

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yu-Wen Tien, M.D., Ph. D.

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Central Contacts

Shih-Hung Yang, M.D.

Role: CONTACT

Phone: +886-2-23123456

Email: 018500@ntuh.gov.tw

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

201610076MIPB

Identifier Type: -

Identifier Source: org_study_id