Chemotherapy treatment for advanced gastric cancer before and after surgery

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

This study is testing a new chemotherapy combination for people with advanced stomach cancer to see if it helps them respond better to surgery and live longer without the cancer coming back.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: National Cheng-Kung University Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 4 sites (Kaohsiung and 3 other locations)
• Trial ID: NCT04999332 on ClinicalTrials.gov

What this trial studies

This trial investigates the effectiveness and safety of a chemotherapy regimen combining leucovorin, oxaliplatin, docetaxel, and S-1 (LOTS) for patients with locally advanced gastric or gastroesophageal junction adenocarcinoma. Participants will receive four cycles of LOTS chemotherapy before surgery and another four cycles after surgery. The study aims to evaluate the primary outcome of pathological response and curative resection rate, along with secondary outcomes such as recurrence-free survival and overall survival. It is an open-label, single-arm, multi-center phase II trial conducted in Taiwan.

Who should consider this trial

Good fit: Ideal candidates are adults over 20 years old with histologically-confirmed locally advanced gastric or gastroesophageal junction adenocarcinoma and measurable lesions.

Not a fit: Patients with early-stage gastric cancer or those with non-resectable disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve surgical outcomes and survival rates for patients with advanced gastric cancer.

How similar studies have performed: Other studies have shown promising results with similar perioperative chemotherapy approaches, indicating potential for success in this trial.

Eligibility criteria

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.

Where this trial is running

Kaohsiung and 3 other locations

• Kaohsiung Veterans General Hospital — Kaohsiung, Taiwan (Recruiting)
• China Medical University Hospital — Taichung, Taiwan (Not_yet_recruiting)
• National Cheng Kung University Hospital — Tainan, Taiwan (Recruiting)
• Taipei Veterans General Hospital — Taipei, Taiwan (Not_yet_recruiting)

Study contacts

• Principal investigator: I Shu Chen, M.D. — Department of General Surgery, Kaohsiung Veterans General Hospital
• Study coordinator: Clinical Trial Center, National Cheng-Kung University Hospital

Conditions Gastric Cancer; Gastric Adenocarcinoma; Effects of Chemotherapy; Toxicity Due to Chemotherapy; Gastric cancer; Gastroesophageal junction cancer; Locally advanced; Perioperative chemotherapy