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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: t
View:

• 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).

• 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).

• 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.

• 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.

• 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.

• Subjects have, or agree to establish a vascular access that permits systemic intravenous chemotherapy and are capable of ingesting capsules per oral.

• Subjects with reproductive potentials are willing to accept contraceptive measures during the trial.

• 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.

Locations
Other Locations
Taiwan
Kaohsiung Veterans General Hospital
RECRUITING
Kaohsiung City
China Medical University Hospital
NOT_YET_RECRUITING
Taichung
National Cheng Kung University Hospital
RECRUITING
Tainan City
Taipei Veterans General Hospital
NOT_YET_RECRUITING
Taipei
Contact Information
Primary
Clinical Trial Center, National Cheng-Kung University Hospital
ctcnckuh@mail.hosp.ncku.edu.tw
+886-6-2353535
Backup
Chih Chieh Yen, M.D.
jack7481@gmail.com
+886-6-2353535
Time Frame
Start Date: 2021-12-10
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 58
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: Taipei Veterans General Hospital, Taiwan, China Medical University Hospital, TTY Biopharm, Kaohsiung Veterans General Hospital.
Leads: National Cheng-Kung University Hospital

This content was sourced from clinicaltrials.gov

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