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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
Sponsored by
National Health Research Institutes, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
August 30, 2021
Last Updated
September 26, 2022
Sponsor
National Health Research Institutes, Taiwan
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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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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
No
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
Email
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
Email
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
Email
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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