A Phase II Study of S-1 Adjuvant Chemotherapy in Patients With Resected Pancreatic Cancer in Taiwan

NCT04070313 | Terminated Phase 2

• 1 other identifier: TTYTG1709
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 4

Brief Summary

To verify the efficacy of S-1 adjuvant chemotherapy in resectable pancreatic cancer.

• Primary Endpoint: Relapse-free survival (RFS)
• Secondary Endpoints: 2-year survival rate, 2-year relapse-free survival (RFS) rate, safety profile

Conditions

Resected Pancreatic Cancer; Pancreatic Cancer; Adjuvant Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Relapse-free survival (RFS)

  The time from registration to the time of initial detection of relapse or death from any causewhichever came first, assessed up to 2 years

  2 years

Secondary Outcomes (3)

• 2-year survival rate

  2 years

• 2-year relapse-free survival (RFS) rate

  2 years

• safety profile

  2 years

Study Arms (1)

S-1

EXPERIMENTAL

single-arm

Drug: S-1

Interventions

S-1 DRUG

Eligible patients will receive S-1 orally 80-120 mg/day (depending on patient's body surface area (BSA)) on day 1 to 28 in a 6-week cycle.

S-1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with resected adenocarcinoma pancreatic cancer that was histologically verified.
• Patients with macroscopic total resection of the primary tumor, and confirmed local residual tumor classified as R0/R1.
• Absence of distant metastases and malignant ascites
• Adequate oral intake
• Age of 20 years or above
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or1
• Adequate hematopoietic which is defined as below,
• White blood cell count: 3,000/mm3, ≤ 12,000/mm3
• Platelet count: 100,000/mm3
• Hemoglobin: 8.0 g/dL
• ANC: 1500/mm3
• CA19-9 ≤ 100 U/mL
• Absence used of chemotherapy or radiotherapy
• Within 10 weeks following resection of pancreatic cancer
• Written informed consent given

You may not qualify if:

• Patient previously received adjuvant therapy for pancreatic cancer
• Patient previously received S-1 treatment and concurrent using other fluoropyrimidine-group anti-cancer drugs, combination therapies with them (such as folinate plus Tegafur-Uracil combination therapy)
• Recurrence prior to registration
• Moderate or more severe pleural effusion or ascites upon abdominal CT
• Inadequate hepatic function which is defined as below:
• Total bilirubin greater than 1.5 times the ULN
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)greater than 2.5 times the ULN
• Inadequate renal function which is defined as below:
• Creatinine clearance rate (CCr) \< 60 mL/min
• Heart failure of Class III (Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea.) or Class IV (Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.) according to the New York Heart Association functional classification
• Other serious complications such as active peptic ulcer, paresis of intestine or any others
• Pulmonary fibrosis or interstitial pneumonia clearly observed
• Uncontrolled watery diarrhea Whether a patient has diarrhea 4 or more times a day while receiving adequate supportive therapy will be used as the indicator to determine whether watery diarrhea is inadequately controlled.
• Blood transfusion within 2 weeks prior to registration
• Myocardial infarction within 6 months following documentation of pancreatic cancer

Sponsors & Collaborators

• TTY Biopharm: lead
• Taipei Veterans General Hospital, Taiwan: collaborator
• National Taiwan University Hospital: collaborator
• Chang Gung Memorial Hospital: collaborator
• National Cheng-Kung University Hospital: collaborator

Study Sites (4)

Chang Gung Memorial Hospital_Linkou

Linkou District, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hospital, Taiwan

Taipei, Taiwan

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

S 1 (combination)

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

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

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: August 28, 2019
• Study Start: July 11, 2019
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: December 6, 2021

Record last verified: 2021-11

Locations

TW (4)