search
Back to results

A Phase 2 Study of Neoadjuvant Docetaxel, Oxaliplatin, S-1 in Patients With Unresectable Locally Advanced or Distant Metastasis Limited to Lymph Node Gastric Cancer

Primary Purpose

Stomach Neoplasm

Status
Recruiting
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Docetaxel injection, oxaliplatin, S-1
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Neoplasm focused on measuring Neo-adjuvant/Adjuvant, distant metastasis limited to lymph node gastric cancer, unresectable locally advanced gastric cancer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Histologically or cytologically proven metastatic gastric adenocarcinoma patients
  2. As a patient who has been proven by CT to have invasion of surrounding organs (T4) according to the 8th edition of the American Joint Commission (AJCC) or confined to remote lymph nodes, the criteria for lymph node invasion are 8 mm or more in single diameter and central necrosis (rounder), (Refer to Appendix B)
  3. Over 18 years old.
  4. Patients with a life expectancy of at least 3 months.
  5. Patients with 0 or 1 ECOG performance status
  6. As defined in the relevant items below, those who have confirmed appropriate normal organ and bone marrow function:

    • Haemoglobin 9 9.0 g/dL.
    • Absolute neutrophil count (ANC) > 1.5 x 103/mCL (> 1,500 per mm3)
    • Platelet count 100 100 x 109/L
    • Serum bilirubin 1.5 1.5 x Test Laboratory Upper Limit of Normal (ULN).
    • AST(SGOT)/ALT(SGPT) 2.5 2.5x ULN of test institution.
    • Measured creatinine clearance (CL) > 40 mL/min or Cockcroft-Gault formula (Cockcroft and Gault 1976) calculated by or according to 24-hour urine samples for determining creatinine cleaning rates.

      • Male creatinine CL (mL/min) = Weight (kg)x (140-age) / 72x Serum creatinine (mg/dL)
      • Women's creatinine CL (mL/min) = Weight (kg)x (140-age) / 72 x Serum creatinine (mg/dL) x 0.85
  7. A patient who has never had chemotherapy before.
  8. Patients who have not previously had radiation therapy experience
  9. Physical, family, social, and geographic conditions for the follow-up of patient conditions required for this study should be free of obstacles in this study.
  10. Evidence of menopause or negative findings of urine or blood pregnancy response should be confirmed in premenopausal women. Women who are premenstrual for more than 12 months without any other medical cause are considered menopause. In addition, if bilateral ovarian resection, bilateral ovariectomy, and hysterectomy are performed, menopause is considered.
  11. Subjects who can provide signed consent, such as compliance with the requirements and taboos specified in the test subject's consent (ICF) and this plan. Written consent must be obtained from the patient and the patient's legal representative prior to implementing the plan-related procedures, including screening evaluation.

Exclusion Criteria:

  1. When pregnant women, lactating women, or pregnant women do not use appropriate contraception methods.
  2. Cancer other than adenocarcinoma.
  3. Patients with distant metastasis other than lymph nodes or confirmed ascites on abdominal CT before surgery.
  4. History of other carcinomas or presence of pathogenic cancer (excluding non-melanoma skin cancer or cervical epithelial cancer)
  5. Central nervous system metastasis.
  6. Clinically significant intestinal obstruction or gastrointestinal bleeding.
  7. A patient with a history of organ transplantation.
  8. Active infections such as tuberculosis, hepatitis B, hepatitis C, or HIV identified by TB tests according to medical history, physical examination, radiological findings, and regional standards.

    • Tuberculosis: Tuberculosis confirmed by medical history, physical examination, or radiologically active tuberculosis, and tuberculosis tests according to regional standards (excluding active TB, old TB is acceptable)
    • Hepatitis B: If HBsAg is negative, register, and if HBsAg is positive, HBV DNA test is performed.

      • HBV DNA 500 500iu/ml (or 2500 copies/ml): Excluded
      • HBV DNA ▶500iu/ml (or 2500 copies/ml): Allow
    • Hepatitis C: If HCV Ab is negative, register, and if HCV Ab is positive, HCV RNA test is performed.

      • If HCV RNA is positive, I'll exclude it.
      • If it's HCV RNA's voice, it's allowed.
    • HIV: HIV Ag/Ab : excluding reactive faces, HIV Ag/Ab : non-reactive faces registration
  9. Average QTcF (average QT interval for heart rate correction using fridericia formula) > 470 ms when calculated with three ECG tests (within 15 minutes at 2-5 minute intervals).

    If -1 test is performed and QTcF > 470 ms, 2 additional tests are performed to determine the average QTcF value.

    -If QTcF 4 470 ms after one test, no additional test is performed.

  10. Other serious diseases or medical conditions.

    • Uncurable unstable heart disease, myocardial infarction within 6 months before the start of the study.
    • A history of neurological or psychiatric diseases including dementia or seizures.
    • Active, non-regulatory infection.
    • Clinically serious diarrhea.
    • Severe high calcium conditions above 12 mg/dL, which are not controlled by phonates.
    • Other serious medical conditions that may affect participation in this study.
    • Active random intravascular coagulation.
  11. Patients who other researchers find inappropriate.
  12. In the case of recent corticosteroids (or corresponding) treatment, except for acute hypersensitivity response therapy or low-dose (<20 mg methylprednisolone or corresponding) chronic treatment (started 6 months before the start of the study) as preventive therapy,
  13. In addition to the test drug, administration of other clinical research drugs within 4 weeks or in combination.
  14. Combination chemotherapy, hormone therapy, or immunotherapy.

Sites / Locations

  • Asan Medical Center, University of Ulsan College of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment

Arm Description

treatment arm(docetaxel, oxaliplatin, S-1)

Outcomes

Primary Outcome Measures

Evaluation of R0 resection rate in patients who underwent prior chemotherapy as a clinical trial.
Evaluation of R0 resection rate.

Secondary Outcome Measures

Full Information

First Posted
December 21, 2021
Last Updated
January 27, 2023
Sponsor
Asan Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT05184803
Brief Title
A Phase 2 Study of Neoadjuvant Docetaxel, Oxaliplatin, S-1 in Patients With Unresectable Locally Advanced or Distant Metastasis Limited to Lymph Node Gastric Cancer
Official Title
A Phase 2 Study of Neoadjuvant Docetaxel, Oxaliplatin, S-1 in Patients With Unresectable Locally Advanced or Distant Metastasis Limited to Lymph Node Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

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
Gastric cancer is the fifth most common carcinoma in the world, and cancer-related deaths rank third. It is one of the main causes of death from cancer in Korea. The cure method for gastric cancer is radical resection, but in most patients, radical resection is impossible due to local infiltration or peripheral organ or distant metastasis. Many assisted chemotherapy has been studied to improve survival rate, and in East Asia, assisted chemotherapy after complete D2 resection is the standard treatment. In the West, on the other hand, preoperative chemotherapy and postoperative assisted chemotherapy are currently standard treatments. However, due to the limited effect of adjuvant chemotherapy, it has been reported that better clinical course can be improved by increasing anticancer intensity. In this context, a large number of prior chemotherapy have been attempted, and prior chemotherapy has several potential effects as follows. (1) Improvement of R0 resection rate due to reduced primary cancer size, (2) early treatment for micro metastasis, (3) evaluation of treatment response rate in patients with measurable lesions, and (4) unnecessary laparotomy can be avoided in patients with biologically aggressive diseases. Based on the efficacy of chemotherapy in the combination of docetaxel, fluoropyrimidine, and platinum in metastatic gastric cancer, the investigators conducted a preceding auxiliary anti-cancer clinical trial of docetaxel, capecitabine and cisplatin in advanced gastric cancer patients who could not be completely resected by surgery. DXP was performed 4-6 cycles before surgery with the recommended dose in phase 1-2. In a total of 49 patients, R0 resection was performed in 31 (63%), and among patients, R0 resection was improved in cases where resection was not possible due to local infiltration (71%) and in cases where para-aortic node metastasis was performed (73%). We have reported that docetaxel, oxaliplatin, and S-1 chemotherapy (DOS) as preoperative adjuvant therapy can be safely administered in combination with D2 gastrectomy and postoperative adjuvant therapy S-1 in potentially resectable local progressive gastric cancer patients. R0 resection was achieved in 97.6% of patients, and pathological complete remission was observed in 19.5%. Based on this, a phase 3 PRODIGY study was performed to evaluate the benefit of S-1 (CSC group) as a preoperative prior chemotherapy compared to S-1 (SC group) as a postoperative adjuvant therapy in gastric cancer of cT2/3N+ or cT4Nany stage, and 0.75% of the CSC group was administered HR. In the patient group undergoing surgery, the R0 resection rate was 95% in the CSC group and 84% in the SC group. In the CSC group, the pathological complete remission rate was 10.4%. Based on these results, a clinical trial of DOS as a preoperative chemotherapy was planned for progressive gastric cancer that could not be resected due to local progression or metastasis limited to remote lymph nodes. Primary goal: Evaluation of R0 resection rate in patients who underwent prior chemotherapy as a clinical trial. Secondary objective: safety evaluation, overall survival period, progression-free survival period, pathological complete remission rate, and investigation of biological markers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasm
Keywords
Neo-adjuvant/Adjuvant, distant metastasis limited to lymph node gastric cancer, unresectable locally advanced gastric cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment
Arm Type
Experimental
Arm Description
treatment arm(docetaxel, oxaliplatin, S-1)
Intervention Type
Drug
Intervention Name(s)
Docetaxel injection, oxaliplatin, S-1
Intervention Description
As a prior chemotherapy, intravenous administration is performed every 3 weeks for docetaxel 50 mg/m2 D1, intravenous administration for oxaliplatin 100 mg/m2 D1, and oral administration twice a day for S-140 mg/m2 D1 to 14.
Primary Outcome Measure Information:
Title
Evaluation of R0 resection rate in patients who underwent prior chemotherapy as a clinical trial.
Description
Evaluation of R0 resection rate.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically proven metastatic gastric adenocarcinoma patients As a patient who has been proven by CT to have invasion of surrounding organs (T4) according to the 8th edition of the American Joint Commission (AJCC) or confined to remote lymph nodes, the criteria for lymph node invasion are 8 mm or more in single diameter and central necrosis (rounder), (Refer to Appendix B) Over 18 years old. Patients with a life expectancy of at least 3 months. Patients with 0 or 1 ECOG performance status As defined in the relevant items below, those who have confirmed appropriate normal organ and bone marrow function: Haemoglobin 9 9.0 g/dL. Absolute neutrophil count (ANC) > 1.5 x 103/mCL (> 1,500 per mm3) Platelet count 100 100 x 109/L Serum bilirubin 1.5 1.5 x Test Laboratory Upper Limit of Normal (ULN). AST(SGOT)/ALT(SGPT) 2.5 2.5x ULN of test institution. Measured creatinine clearance (CL) > 40 mL/min or Cockcroft-Gault formula (Cockcroft and Gault 1976) calculated by or according to 24-hour urine samples for determining creatinine cleaning rates. Male creatinine CL (mL/min) = Weight (kg)x (140-age) / 72x Serum creatinine (mg/dL) Women's creatinine CL (mL/min) = Weight (kg)x (140-age) / 72 x Serum creatinine (mg/dL) x 0.85 A patient who has never had chemotherapy before. Patients who have not previously had radiation therapy experience Physical, family, social, and geographic conditions for the follow-up of patient conditions required for this study should be free of obstacles in this study. Evidence of menopause or negative findings of urine or blood pregnancy response should be confirmed in premenopausal women. Women who are premenstrual for more than 12 months without any other medical cause are considered menopause. In addition, if bilateral ovarian resection, bilateral ovariectomy, and hysterectomy are performed, menopause is considered. Subjects who can provide signed consent, such as compliance with the requirements and taboos specified in the test subject's consent (ICF) and this plan. Written consent must be obtained from the patient and the patient's legal representative prior to implementing the plan-related procedures, including screening evaluation. Exclusion Criteria: When pregnant women, lactating women, or pregnant women do not use appropriate contraception methods. Cancer other than adenocarcinoma. Patients with distant metastasis other than lymph nodes or confirmed ascites on abdominal CT before surgery. History of other carcinomas or presence of pathogenic cancer (excluding non-melanoma skin cancer or cervical epithelial cancer) Central nervous system metastasis. Clinically significant intestinal obstruction or gastrointestinal bleeding. A patient with a history of organ transplantation. Active infections such as tuberculosis, hepatitis B, hepatitis C, or HIV identified by TB tests according to medical history, physical examination, radiological findings, and regional standards. Tuberculosis: Tuberculosis confirmed by medical history, physical examination, or radiologically active tuberculosis, and tuberculosis tests according to regional standards (excluding active TB, old TB is acceptable) Hepatitis B: If HBsAg is negative, register, and if HBsAg is positive, HBV DNA test is performed. HBV DNA 500 500iu/ml (or 2500 copies/ml): Excluded HBV DNA ▶500iu/ml (or 2500 copies/ml): Allow Hepatitis C: If HCV Ab is negative, register, and if HCV Ab is positive, HCV RNA test is performed. If HCV RNA is positive, I'll exclude it. If it's HCV RNA's voice, it's allowed. HIV: HIV Ag/Ab : excluding reactive faces, HIV Ag/Ab : non-reactive faces registration Average QTcF (average QT interval for heart rate correction using fridericia formula) > 470 ms when calculated with three ECG tests (within 15 minutes at 2-5 minute intervals). If -1 test is performed and QTcF > 470 ms, 2 additional tests are performed to determine the average QTcF value. -If QTcF 4 470 ms after one test, no additional test is performed. Other serious diseases or medical conditions. Uncurable unstable heart disease, myocardial infarction within 6 months before the start of the study. A history of neurological or psychiatric diseases including dementia or seizures. Active, non-regulatory infection. Clinically serious diarrhea. Severe high calcium conditions above 12 mg/dL, which are not controlled by phonates. Other serious medical conditions that may affect participation in this study. Active random intravascular coagulation. Patients who other researchers find inappropriate. In the case of recent corticosteroids (or corresponding) treatment, except for acute hypersensitivity response therapy or low-dose (<20 mg methylprednisolone or corresponding) chronic treatment (started 6 months before the start of the study) as preventive therapy, In addition to the test drug, administration of other clinical research drugs within 4 weeks or in combination. Combination chemotherapy, hormone therapy, or immunotherapy.
Facility Information:
Facility Name
Asan Medical Center, University of Ulsan College of Medicine
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoon-Koo Kang, MD, PhD
Phone
+82-2-3010-3230
Email
ykkang@amc.seoul.kr
First Name & Middle Initial & Last Name & Degree
Min-Hee Ryu, MD, PhD
Phone
+82-2-3010-5935
Email
miniryu@amc.seoul.kr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Phase 2 Study of Neoadjuvant Docetaxel, Oxaliplatin, S-1 in Patients With Unresectable Locally Advanced or Distant Metastasis Limited to Lymph Node Gastric Cancer

We'll reach out to this number within 24 hrs