Perioperative Leucovorin, Oxaliplatin, Docetaxel and S-1 (LOTS) For Locally Advanced Gastric or Gastroesophageal Junction Cancer (LOTS)

November 14, 2023 updated by: YS Shan, MD, PhD, National Cheng-Kung University Hospital

A Phase II Trial of Perioperative Chemotherapy With Leucovorin, Oxaliplatin, Docetaxel and S-1 (LOTS) For Patients With Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

The aim of the trial is to investigate the clinical efficacy and toxicity of perioperative chemotherapy with leucovorin, oxaliplatin, docetaxel and S-1 (LOTS) in patients with locally advanced gastric or gastroesophageal junction adenocarcinoma who receive a curative surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study is an open-label, single-arm, single-country and multi-center phase II investigator-initiated trial. Patients with locally advanced gastric or gastroesophageal junction adenocarcinoma who enroll the trial will receive perioperative chemotherapy with LOTS (14 days as a cycle) 4 cycles every 2 weeks, followed by operation and another 4 cycles every 2 weeks post-operatively. The primary outcome is pathological response or curative resection rate. The secondary outcome includes recurrence-free survival, overall survival, disease control rate, protocol completion rate and adverse events.

Study Type

Interventional

Enrollment (Estimated)

58

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 813
        • Recruiting
        • Kaohsiung Veterans General Hospital
        • Contact:
      • Taichung, Taiwan, 404
        • Not yet recruiting
        • China Medical University Hospital
        • Contact:
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital
        • Contact:
        • Sub-Investigator:
          • Ying Jui Chao, M.D.
        • Sub-Investigator:
          • Ting Kai Liao, M.D.
        • Sub-Investigator:
          • Ping Jui Su, M.D.
        • Sub-Investigator:
          • I Ting Liu, M.D.
        • Sub-Investigator:
          • Kwang Yu Chang, M.D., Ph.D.
        • Sub-Investigator:
          • Chien Jui Huang, M.D.
      • Taipei, Taiwan, 112
        • Not yet recruiting
        • Taipei Veterans General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Subjects have histologically-confirmed gastric or gastroesophageal junction (classified as Siewert type III) adenocarcinoma with a clinical stage of T3 or above, lymph node involvement (N+) or both according to American Joint Cancer Committee staging system, 8th edition (AJCC 8th).
  2. Subjects present with at least one measurable lesion which can be accurately assessed by conventional techniques at least 2.0 cm or 1.0 cm by computed tomography (CT) or magnetic resonance imaging (MRI).
  3. Subjects have a lymph node-positive disease in which that at least one of the nodes with a diameter greater or equal to 0.8 cm in the long axis. If subjects do not have a node-positive disease, a clinical stage of T3 or above and a measurable tumor is required for inclusion.
  4. Subjects are above 20 years of age with an Eastern Cooperative Oncology Group (ECOG) performance status ≤1, have a life expectancy >3 months, have surgically resectable disease and are physically competent and willing to receive a curative operation.
  5. Subjects have adequate organ functions, including bone marrow reserve with a leukocyte count ≥3,000 /µL and platelet count ≥100,000 /µL, hepatic reserve with a serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 times of upper limits and total bilirubin ≤2.0 mg/dL, renal reserve with a creatinine clearance ≥60 mL/min and cardiac reserve with a left ventricular ejection fraction (LVEF) ≥50% by echocardiography at baseline.
  6. Subjects have, or agree to establish a vascular access that permits systemic intravenous chemotherapy and are capable of ingesting capsules per oral.
  7. Subjects with reproductive potentials are willing to accept contraceptive measures during the trial.
  8. Subjects are functionally and cognitively capable to be informed of the trial contents and objectives (including obtaining blood and tumor tissue for the trial investigation), and agree to sign the written consent for enrollment.

Exclusion Criteria:

  1. Subjects have metastatic (M1, including washing cytology positive for peritoneal carcinomatosis), recurrent gastric/gastroesophageal junction cancer (defined by an interval time less than five years from the current diagnosis to the prior initial disease), or any other underlying primary malignancies excluding carcinoma in situ or resectable skin cancer.
  2. Subjects have received chemotherapies within 2 years, or a major abdominal surgery or radiotherapy within 4 weeks before the trial enrollment.
  3. Subjects are known to be allergic to any of the studied chemotherapeutics.
  4. Subjects have underlying chronic illnesses, including cardiopulmonary diseases, ischemic heart disease, inflammatory bowel disease, poorly-controlled diabetes mellitus, liver cirrhosis and/or peripheral neuropathy of any etiologies.
  5. Subjects have active bacterial, viral, fungal or mycobacterial infections that require systemic therapy, including active infection with human immunodeficiency virus (HIV), hepatitis B or C virus (HBV or HCV)
  6. Subjects are planning to conceive or already in pregnancy or breastfeeding.
  7. Subjects are currently participating in any other clinical trials or studies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Perioperative chemotherapy with LOTS

LOTS as one cycle:

Leucovorin (30 mg) twice daily per oral, day 1 to 7; Oxaliplatin (85 mg per square meter) intravenously, day 1; Docetaxel (40 mg per square meter) intravenously, day 1; S-1 (35 mg per square meter) twice daily per oral, day 1 to 7

Pre-operative part:

Four cycles of LOTS every two weeks

Operative part:

Curative gastrectomy or gastroesophagectomy plus D2 lymphadenectomy

Post-operative part:

Four cycles of LOTS every two weeks
Drug: leucovorin, oxaliplatin, docetaxel, S-1
Perioperative chemotherapy with LOTS
Other Names:
  • leucovorin (Folina tab, TTY Biopharm, TW)
  • oxaliplatin (Oxalip, TTY Biopharm, TW)
  • docetaxel (Taxotere, Sanofi-Aventis, FR)
  • S-1 (TS-1, Taiho, JP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological response
Time Frame: after pre-operative chemotherapy and curative surgery (Week 11 to 13)
the tumor pathological response after pre-operative chemotherapy with LOTS plus curative surgery. The pathological response is defined by tumor evaluation of complete, partial or no response according to tumor regression grading (TRG)
after pre-operative chemotherapy and curative surgery (Week 11 to 13)
Curative resection rate
Time Frame: after pre-operative chemotherapy and curative surgery (Week 11 to 13)
the rate of margin-free (R0) resection in the absence of macro- or microscopic residual tumors remaining at the primary tumor bed
after pre-operative chemotherapy and curative surgery (Week 11 to 13)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-free survival
Time Frame: From date of the initiation of trial treatment until the date of disease recurrence, progression or death at any causes, whichever came first, assessed up to 48 months
the time interval from the initiation of trial treatment to disease recurrence, progression or death at any causes
From date of the initiation of trial treatment until the date of disease recurrence, progression or death at any causes, whichever came first, assessed up to 48 months
Overall survival
Time Frame: From date of the initiation of trial treatment until the date of death at any causes, assessed up to 48 months
the time interval from the initiation of trial treatment to death at any causes
From date of the initiation of trial treatment until the date of death at any causes, assessed up to 48 months
Disease control rate
Time Frame: From date of the initiation of trial treatment until the date of recurrence/death events, withdrawal from the trial at any causes, termination/completion of the trial, whichever came first, assessed up to 48 months
the rate of patients remaining in disease control (complete, partial response and stable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines version 1.1) lasting at least three months
From date of the initiation of trial treatment until the date of recurrence/death events, withdrawal from the trial at any causes, termination/completion of the trial, whichever came first, assessed up to 48 months
Protocol completion rate
Time Frame: From date of the initiation of trial treatment until the date of recurrence/death events, withdrawal from the trial at any causes, termination/completion of the trial, whichever came first, assessed up to 48 months
the rate of patients completing the pre-specified protocol treatment
From date of the initiation of trial treatment until the date of recurrence/death events, withdrawal from the trial at any causes, termination/completion of the trial, whichever came first, assessed up to 48 months
Treatment-emergent adverse event rate
Time Frame: From date of the initiation of trial treatment until the date of recurrence/death events, withdrawal from the trial at any causes, termination/completion of the trial, whichever came first, assessed up to 48 months
the rate of protocol treatment-emergent adverse events, as graded by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
From date of the initiation of trial treatment until the date of recurrence/death events, withdrawal from the trial at any causes, termination/completion of the trial, whichever came first, assessed up to 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng-Kung University Hospital

Collaborators

China Medical University Hospital
Taipei Veterans General Hospital, Taiwan
Kaohsiung Veterans General Hospital.
TTY Biopharm

Investigators

  • Study Chair: Chia Jui Yen, M.D., Ph.D., Department of Oncology, National Cheng Kung University Hospital
  • Study Director: Yan Shen Shan, M.D., Ph.D., Department of Surgery, National Cheng Kung University Hospital
  • Principal Investigator: I Shu Chen, M.D., Department of General Surgery, Kaohsiung Veterans General Hospital
  • Principal Investigator: Li Yuan Bai, M.D., Ph.D., Department of Hematology/Oncology, China Medical University Hospital
  • Principal Investigator: Ming Huang Chen, M.D., Ph.D., Department of Oncology, Taipei Veterans General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

July 8, 2021

First Submitted That Met QC Criteria

August 5, 2021

First Posted (Actual)

August 10, 2021

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOTS-GC-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All individual participant data which are processed with de-identification procedures and underlie results in a scientific publication

IPD Sharing Time Frame

Upon publication of the data to a duration of ten years

IPD Sharing Access Criteria

Upon a formal request to the trial chairperson or chief principal investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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