S-1+Oxaliplatin vs.S-1+Cisplatin First-line Treatment of Advanced or Recurrent Diffuse Gastric Adenocarcinoma Patients
Conditions
Gastric Cancer
Conditions: official terms
Adenocarcinoma - Esophageal Neoplasms - Stomach Neoplasms
Conditions: Keywords
Diffuse-type gastric cancer, Advance Gastric Cancer, Recurrent Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, SOX, S-1+Oxaliplatin, OS,, ORR,, TTP,, TTF,, safety
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: S-1 Type: Drug
Name: Oxaliplatin Type: Drug
Name: Cisplatin Type: Drug
Overall Status
Recruiting
Summary
The purpose of this study is to evaluate the effectiveness and safety of S-1+Oxaliplatin vs.S-1+Cisplatin First-line Treatment in Advanced or Recurrent Diffuse Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma Patients.
Detailed Description
The primary endpoint is Overall survival time (OS).Secondary is overall response rate (ORR), time to treatment failure (TTF),treatment to progression time (TTP)and the adverse reactions of the two groups (AE).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. histologically confirmed unresectable advanced or recurrent diffuse-type gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.

2. 18 years old to 75 years old, able to conduct oral administration.

3. Measurable disease, according to the Response Evaluation Criteria in Solid Tumours(RECIST 1.1),except non-measurable but evaluable disease,such as peritoneal metastasis

4. No palliative chemotherapy and radiotherapy. Previous adjuvant or neoadjuvant chemotherapy , if applicable, more than 12 months.

5. ECOG systemic status score of 0 to 2.

6. normal organ function, that meet the following criteria:

1. ALT and AST<2.5 times ULN (≤5 times ULN in patients with liver metastases)

2. ALP ≤ 2 times ULN ; (for patients with liver metastases can be no limit to the ALP).

3. Total bilirubin ≤ 1 times ULN.

4. Absolute neutrophil count ≥ 2.0 × 10 9 / L.

5. Platelet count ≥ 100 × 10 9 / L.

6. Hemoglobin ≥ 80g / L.

7. Creatinine ≤ 1.25 times ULN.

8. The estimated creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula).

7. signed informed consent, treatment, follow-up and inspection in accordance with the study protocol.

8. life expectancy greater than 3 months.

9. at least 3 weeks after major surgery.

Exclusion Criteria:

1. Previous adjuvant or neoadjuvant chemotherapy within the prescribed time

2. the investigator determines that the patient is not suitable for participation in this study, and specifically includes (but is not limited to):

1. The past five years there have been other malignancies, but after appropriate treatment of cervical carcinoma in situ and non-melanoma skin cancer.

2. brain metastases or leptomeningeal metastasis.

3. myocardial infarction (within the past six months), severe unstable angina, congestive heart failure.

4. Serious complications (including paralytic ileus, intestinal obstruction, interstitial pneumonia, lung fibrosis, beyond the control of diabetes, renal insufficiency and cirrhosis of the liver, etc.).

5. Chronic nausea, vomiting, or diarrhea (per day greater than or equal to 4 times or watery stools).

6. Gastrointestinal bleeding, and need for frequent blood transfusions.

7. human immunodeficiency virus (HIV) carrier or suffering from AIDS (AIDS).

8. Suffering from a mental illness.

9. neuropathy severity ≥grade 2 .

10. Infectious disease or inflammation, body temperature ≥ 38 ℃.

3. Cisplatin, oxaliplatin, or S-1 allergy.

4. Pregnancy or breast-feeding women.

5. refused to take appropriate contraceptive measures (including male patients).

6. Under experimental drug within 4 weeks.

7. Under other anti-cancer treatment.
Locations
Sun Yat-sen University Cancer Center
Gaungzhou, Guangdong, China
Status: Not yet recruiting
Contact: Ruihua Xu, Professor - 862087343228 - xurh@sysucc.org.cn
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Status: Recruiting
Contact: Ruihua Xu, phD - 86-20-87342479 - xurh@sysucc.org.cn
Start Date
April 2013
Completion Date
April 2016
Sponsors
Sun Yat-sen University
Source
Sun Yat-sen University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page