S-1+Oxaliplatin vs.S-1+Cisplatin First-line Treatment of Advanced or Recurrent Non-intestinal Typ… (NCT01824459) | Clinical Trial Compass
CompletedPhase 3
S-1+Oxaliplatin vs.S-1+Cisplatin First-line Treatment of Advanced or Recurrent Non-intestinal Type Gastric Adenocarcinoma Patients
China576 participantsStarted 2013-04
Plain-language 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 Non-intestinal Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma Patients.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. histologically confirmed unresectable advanced or recurrent diffuse-type or mixed-type gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
✓. 18 years old to 75 years old, able to conduct oral administration.
✓. Measurable disease or non-measurable but evaluable disease, according to the Response Evaluation Criteria in Solid Tumours(RECIST 1.1)
✓. No palliative chemotherapy and radiotherapy. Previous adjuvant or neoadjuvant chemotherapy , if applicable, more than 12 months.
✓. ECOG systemic status score of 0 to 2.
✓. normal organ function, that meet the following criteria:
✓. ALT and AST(≤2.5 times ULN (≤5 times ULN in patients with liver metastases)
✓. ALP ≤ 2 times ULN ; (for patients with liver metastases can be no limit to the ALP).
Exclusion criteria
✕. Previous adjuvant or neoadjuvant chemotherapy within the prescribed time
✕. the investigator determines that the patient is not suitable for participation in this study, and specifically includes (but is not limited to):
✕. The past five years there have been other malignancies, but after appropriate treatment of cervical carcinoma in situ and non-melanoma skin cancer.
✕. myocardial infarction (within the past six months), severe unstable angina, congestive heart failure.
✕. Serious complications (including paralytic ileus, intestinal obstruction, interstitial pneumonia, lung fibrosis, beyond the control of diabetes, renal insufficiency and cirrhosis of the liver, etc.).
✕. Chronic nausea, vomiting, or diarrhea (per day greater than or equal to 4 times or watery stools).
✕. Gastrointestinal bleeding, and need for frequent blood transfusions.