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Pancreatic Ductal AdenocarcinomaPhase 2NCT05048524

Peri-operative SLOG for Localized Pancreatic Cancer

A Phase 2 study testing S-1, leucovorin, oxaliplatin and gemcitabine in people with Pancreatic Ductal Adenocarcinoma and Pancreas Cancer, run by National Health Research Institutes, Taiwan at 3 sites in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
S-1, leucovorin, oxaliplatin and gemcitabine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
3 sitesTaiwan
Study dates
3 Sep 2021to 24 Aug 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Patients must agree to receive biopsy for histological diagnosis and provide residual tissue for biomarker analysis before chemotherapy
  • Patients must agree to provide tissue for biomarker analysis after neoadjuvant chemotherapy, either surgical specimen or follow-up biopsy in unsectable disease
  • At least one measurable lesion according to RECIST version 1.1
  • Ability to understand and willingness to sign a written informed consent document.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Show all 16Show fewer
  • Age of 20 years or above
  • Life expectancy of at least 12 weeks
  • 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
  • Patients with childbearing potential shall have effective contraception for both the patient and his or her partner during the study.

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

Taiwan3 sites, 3 recruiting

  • Kaohsiung Medical University Hospital

    Kaohsiung City

    Hui-Ching Wang, MD, +8867-3121101, hcwang@kmu.edu.tw

    Hui-Ching Wang

    Recruiting

  • National Cheng-Kung University Hospital

    Tainan

    Yung-Yeh Su, MD, +886-6-7000123 ext. 65181, yysu@nhri.edu.tw

    Li-Tzong Chen, MD, PhD

    Recruiting

  • National Institute of Cancer Research

    Tainan

    Yung-Yeh Su, MD, +8867-7000123 ext. 65181, yysu@nhri.edu.tw

    Li-Tzong Chen, MD, PhD

    Recruiting

Other trials in Taiwan

About this study

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

  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
Read the 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.

Being tested
S-1, leucovorin, oxaliplatin and gemcitabine
Keywords
Neoadjuvant Therapy, SLOG, S-1, Leucovorin, Oxaliplatin, Gemcitabine
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • S-1, leucovorin, oxaliplatin and gemcitabineDrug

    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
Study groups in NCT05048524
Study groupRoleWhat they receive
SLOGExperimentalNot described
Receives: Drug: S-1, leucovorin, oxaliplatin and gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The percentage of subjects with R0 resection after surgery

    Measured: 1 year

Secondary outcomes (8)

  1. The percentage of subjects successfully underwent surgery after study drug treatment

    Measured: 1 year

  2. The percentage of subjects with tumor shrinkage >30%

    according to RECIST 1.1

    Measured: 1 year

  3. The percentage of subjects without tumor progression

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

    Measured: 1 year

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

    Measured: 1 year

  5. Overall survival (OS) of patient received study treatment

    Measured: 2 years

  6. Duration of response (DOR) of patient received study treatment

    Measured: 1 year

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

    Measured: 2 years

  8. 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.

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2021
  2. Study start3 Sep 2021
  3. Primary completion24 Aug 2024 (estimated)
  4. Study completion24 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Two cohorts: unresectable and resectable
Masking
None (open label)
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05048524
Sponsor's protocol ID
SLOG
Status last verified
Mar 2024
First submitted
30 Aug 2021
Last updated
27 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing S-1, leucovorin, oxaliplatin and gemcitabine in people with Pancreatic Ductal Adenocarcinoma and Pancreas Cancer, run by National Health Research Institutes, Taiwan at 3 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The percentage of subjects with R0 resection after surgery (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05048524.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.

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