Peri-operative SLOG for Localized Pancreatic Cancer

NCT05048524 | Recruiting Phase 2

• 1 other identifier: SLOG
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 3

Brief Summary

1. 1.To evaluate the efficacy of neoadjuvant chemotherapy SLOG in localized pancreatic cancer
2. 2.To evaluate the safety profile in patients with pancreatic cancer who receive neoadjuvant SLOG
3. 3.To collect tumor tissue and peripheral blood samples from the patients for a comprehensive biomarker evaluation

Conditions

Pancreatic Ductal Adenocarcinoma; Pancreas Cancer

Keywords

Neoadjuvant Therapy; SLOG; S-1; Leucovorin; Oxaliplatin; Gemcitabine

Outcome Measures

Primary Outcomes (1)

• The percentage of subjects with R0 resection after surgery

  1 year

Secondary Outcomes (8)

• The percentage of subjects successfully underwent surgery after study drug treatment

  1 year

• The percentage of subjects with tumor shrinkage >30%

  1 year

• The percentage of subjects without tumor progression

  1 year

• Progression-free survival (PFS) of patient received study treatment

  1 year

• Overall survival (OS) of patient received study treatment

  2 years

Study Arms (1)

SLOG

EXPERIMENTAL

Drug: S-1, leucovorin, oxaliplatin and gemcitabine

Interventions

S-1, leucovorin, oxaliplatin and gemcitabine DRUG

Gemcitabine 800 mg/m2 on day 1, oxaliplatin 85 mg/m2 on day 1, S-1 orally 80-120 mg/day \[depending on patient's body surface area (BSA)\] on day 1 to 7 and leucovorin 30mg BID day 1 to 7 on in a 2-week cycle. The dose of S-1 is defined as follows: * BSA \< 1.25 m2: 80 mg/day * 1.25 m2 ≤ BSA \< 1.5 m2: 100 mg/day * BSA ≥ 1.5 m2: 120 mg/day

SLOG

Eligibility Criteria

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

You may qualify if:

• A. Localized resectable or potentially resectable pancreatic cancer as determined by image modality; resectability is determined by the treating surgeon No prior treatment for pancreatic cancer
• B. Patients must agree to receive biopsy for histological diagnosis and provide residual tissue for biomarker analysis before chemotherapy
• C. Patients must agree to provide tissue for biomarker analysis after neoadjuvant chemotherapy, either surgical specimen or follow-up biopsy in unsectable disease
• D. At least one measurable lesion according to RECIST version 1.1
• E. Ability to understand and willingness to sign a written informed consent document.
• F. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• G. Age of 20 years or above
• H. Life expectancy of at least 12 weeks
• I. Adequate organ function as defined by the following criteria:
• absolute neutrophil count (ANC) ≥ 1,500/mm3
• hemoglobin level ≥ 9 g/dL
• platelet count ≥ 100,000/mm3
• total bilirubin \< 2 mg/dL
• aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN)
• creatinine clearance rate (CCr) ≥ 50 mL/min (24-hour urine collection or calculated by Cockroft-Gault formula; male: \[(140 - age) × weight (kg)\]/\[72 × serum creatinine(mg/dL)\];female=male x 0.85

You may not qualify if:

• A. Other malignancy within the past 5 years except for adequately treated localized skin cancer or cervical cancer in situ;
• B. Presence of distant metastasis;
• C. Presence of mental disease or psychotic manifestation;
• D. Active or uncontrolled infection;
• E. Significant medical conditions that is contraindicated to study medication or render patient at high risk from treatment complications at physician discretion
• F. Pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential.
• G. History of active autoimmune disease within 3 years or use of steroid more than prednisolone 10mg/day.

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead

Study Sites (3)

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan

RECRUITING

National Cheng-Kung University Hospital

Tainan, Taiwan

RECRUITING

National Institute of Cancer Research

Tainan, Taiwan

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

S 1 (combination); Leucovorin; Oxaliplatin; Gemcitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Two cohorts: unresectable and resectable

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: September 17, 2021
• Study Start: September 3, 2021
• Primary Completion: August 24, 2024
• Study Completion: August 24, 2025
• Last Updated: March 27, 2024

Record last verified: 2024-03

Locations

TW (3)