Peri-operative SLOG for Localized Pancreatic Cancer

NCT ID: NCT05048524

Last Updated: 2024-03-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-03
• Study Completion Date: 2025-08-24

Brief Summary

1. To evaluate the efficacy of neoadjuvant chemotherapy SLOG in localized pancreatic cancer

2. To evaluate the safety profile in patients with pancreatic cancer who receive neoadjuvant SLOG

3. To collect tumor tissue and peripheral blood samples from the patients for a comprehensive biomarker evaluation

Detailed Description

The role of neoadjuvant treatment in pancreatic adenocarcinoma is still under debate due to a relative lack of robust data compared with other gastrointestinal cancers. According to 2020 NCCN guidelines, neoadjuvant is now the accepted approach for borderline resectable (BR) disease, while upfront surgery is still the recommendation for resectable disease except in cases with high risk features. Another important advantage of treatment with neoadjuvant treatment is an increase in the proportion of patients who receive chemotherapy. Traditionally, only patients with a good performance status and a good recovery after surgery are treated with adjuvant chemotherapy. About 45% of patients do not receive adjuvant chemotherapy after resection due to poor performance status, postoperative morbidity, or early progression of disease. A small cohort study using total neoadjuvant FOLFIRINOX for borderline resectable pancreatic cancer yielded a promising result but the tolerability of FOLFIRINOX limited the use of this regimen in Asian population. In previous T1211 clinical trial, the SLOG regimen showed comparable efficacy with a better safety profile in metastatic pancreatic cancer. This phase II trial will evaluate the feasibility of SLOG regimen in patients with localized pancreatic cancer.

Conditions

Pancreatic Ductal Adenocarcinoma; Pancreas Cancer

Study Design

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

Study Groups

SLOG

Group Type: EXPERIMENTAL

S-1, leucovorin, oxaliplatin and gemcitabine

Intervention Type: 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

Interventions

S-1, leucovorin, oxaliplatin and gemcitabine

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

J. Patients with childbearing potential shall have effective contraception for both the patient and his or her partner during the study.

Exclusion Criteria

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.

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

Sponsors

National Health Research Institutes, Taiwan

OTHER

Sponsor Role: lead

Responsible Party

Yung-Yeh Su

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kaohsiung Medical University Hospital

Kaohsiung City, , Taiwan

Site Status: RECRUITING

National Cheng-Kung University Hospital

Tainan City, , Taiwan

Site Status: RECRUITING

National Institute of Cancer Research

Tainan City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Facility Contacts

Hui-Ching Wang, MD

Role: primary

hcwang@kmu.edu.tw

+8867-3121101

Yung-Yeh Su, MD

Role: primary

yysu@nhri.edu.tw

+886-6-7000123 ext. 65181

Yung-Yeh Su, MD

Role: primary

yysu@nhri.edu.tw

+8867-7000123 ext. 65181

Other Identifiers

SLOG

Identifier Type: -

Identifier Source: org_study_id