Skip to main content

Table 1 Eligibility criteria

From: Study protocol of a phase II clinical trial (KSCC1501A) examining oxaliplatin + S-1 for treatment of HER2-negative advanced/recurrent gastric cancer previously untreated with chemotherapy

1) The individual consents in writing to receipt of the protocol treatment.
2) A lead investigator deems that the patient can be treated with the protocol.
3) The cancer is histopathologically confirmed (via resected surgical specimens or biopsied tissue) to be a common type of gastric cancer (adenocarcinoma).
4) Up to 28 days prior to enrollment, contrast-enhanced CT scans of the trunk confirm that 1 or more target lesions is present according to RECIST v1.1 (measurable lesions according to RECIST v1.1).
5) The primary tumor or a metastatic focus is determined to be HER2-negative. Negativity for HER2: 0–1+ on an ICH test, or 2+ on an IHC test and negative on a FISH test (If the result of the IHC test is 2+, the result of the FISH test must be negative, i.e. no HER2 gene amplification).
6) The patient has not previously received chemotherapy, immunotherapy, or radiation therapy (except for local irradiation of bone metastases)*.
7) The patient has advanced/recurrent gastric cancer not amenable to curative surgery.
8) When a patient undergoes surgery for gastric cancer in the form of extensive surgery, standard surgery, or some other procedure, trial participation will be at least 2 weeks afterwards when postoperative complications have abated.
9) The patient’s age upon enrollment is over 20 and under 80 years.
10) The patient has a PS of 0 or 1 on the ECOG Scale.
11) The patient is readily able to take medication orally (patients requiring hyperalimentation for nutritional support are not eligible).
12) The patient is fully expected to survive for 3 months or longer from the day of enrollment.
13) The patient has no severe dysfunction of major organs (bone marrow, liver, kidneys, heart, lungs, etc.) and the patient’s laboratory results from up to 14 days prior to enrollment fall within the criteria. A patient may not receive a transfusion, a hematopoietic growth factor, or a blood product up to 14 days prior to the day that laboratory results are obtained.
i) WBC count ≤12,000 /mm3
ii) Neutrophil count ≥1500 /mm3
iii) Platelet count ≥100,000 /mm3
iv) Hemoglobin ≥8.0 g/dL
v) Total bilirubin ≤1.5 mg/dL
vi) AST,ALT ≤100 IU/L
vii) AST,ALT, 200 IU/L or lower when liver metastasis is noted
viii) Albumin ≥2.5 g/dL
ix) Serum creatinine ≤1.5 mg/dL
x) Creatinine clearance ≥60 mL/min
  1. *Of potential subjects who have received adjuvant chemotherapy with S-1 alone, only individuals who are found to have recurrence at least 180 days after the conclusion of adjuvant chemotherapy will be eligible for enrollment. Patients with recurrence who have received adjuvant chemotherapy with a drug other than S-1 or perioperative adjuvant chemotherapy with S-1 + α will not be eligible for enrollment, regardless of the duration of the period prior to recurrence