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Peri-operative SLOG for Localized Pancreatic Cancer

Primary Purpose

Pancreatic Ductal Adenocarcinoma, Pancreas Cancer

Status

Recruiting

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

S-1, leucovorin, oxaliplatin and gemcitabine

About this trial

This is an interventional treatment trial for Pancreatic Ductal Adenocarcinoma focused on measuring Neoadjuvant Therapy, SLOG, S-1, Leucovorin, Oxaliplatin, Gemcitabine

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Kaohsiung Medical University HospitalRecruiting
National Cheng-Kung University HospitalRecruiting
National Institute of Cancer ResearchRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SLOG

Arm Description

Outcomes

Primary Outcome Measures

The percentage of subjects with R0 resection after surgery

Secondary Outcome Measures

The percentage of subjects successfully underwent surgery after study drug treatment

The percentage of subjects with tumor shrinkage >30%

according to RECIST 1.1

The percentage of subjects without tumor progression

tumor progression is defined as increase of size by >20% according to RECIST 1.1

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

Overall survival (OS) of patient received study treatment

Duration of response (DOR) of patient received study treatment

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Biomarkers of treatment response by single cell RNA sequencing and whole exome sequencing

Biomarkers including but not limited to tumor mutation burden, change of immune cell proportion and percentage of T-reg in the tumor microenvironment.

Full Information

NCT ID

NCT05048524

First Posted

August 30, 2021

Last Updated

September 26, 2022

Sponsor

National Health Research Institutes, Taiwan

1. Study Identification

Unique Protocol Identification Number

NCT05048524

Brief Title

Peri-operative SLOG for Localized Pancreatic Cancer

Official Title

Peri-operative S-1/Leucovorin, Oxaliplatin and Gemcitabine (SLOG) for Localized Pancreatic Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 3, 2021 (Actual)

Primary Completion Date

August 24, 2023 (Anticipated)

Study Completion Date

August 24, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Health Research Institutes, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

To evaluate the efficacy of neoadjuvant chemotherapy SLOG in localized pancreatic cancer To evaluate the safety profile in patients with pancreatic cancer who receive neoadjuvant SLOG 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Ductal Adenocarcinoma, Pancreas Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SLOG

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

S-1, leucovorin, oxaliplatin and gemcitabine

Intervention Description

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

Primary Outcome Measure Information:

Title

The percentage of subjects with R0 resection after surgery

Time Frame

1 year

Secondary Outcome Measure Information:

Title

The percentage of subjects successfully underwent surgery after study drug treatment

Time Frame

1 year

Title

The percentage of subjects with tumor shrinkage >30%

Description

according to RECIST 1.1

Time Frame

1 year

Title

The percentage of subjects without tumor progression

Description

tumor progression is defined as increase of size by >20% according to RECIST 1.1

Time Frame

1 year

Title

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

Time Frame

1 year

Title

Overall survival (OS) of patient received study treatment

Time Frame

2 years

Title

Duration of response (DOR) of patient received study treatment

Time Frame

1 year

Title

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time Frame

2 years

Title

Biomarkers of treatment response by single cell RNA sequencing and whole exome sequencing

Description

Biomarkers including but not limited to tumor mutation burden, change of immune cell proportion and percentage of T-reg in the tumor microenvironment.

Time Frame

4 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Kaohsiung Medical University Hospital

City

Kaohsiung

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hui-Ching Wang, MD

Phone

+8867-3121101

hcwang@kmu.edu.tw

First Name & Middle Initial & Last Name & Degree

Hui-Ching Wang

Facility Name

National Cheng-Kung University Hospital

City

Tainan

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yung-Yeh Su, MD

Phone

+886-6-7000123

Ext

65181

yysu@nhri.edu.tw

First Name & Middle Initial & Last Name & Degree

Li-Tzong Chen, MD, PhD

Facility Name

National Institute of Cancer Research

City

Tainan

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yung-Yeh Su, MD

Phone

+8867-7000123

Ext

65181

yysu@nhri.edu.tw

First Name & Middle Initial & Last Name & Degree

Li-Tzong Chen, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Peri-operative SLOG for Localized Pancreatic Cancer

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