S-1 Plus Oxaliplatin
Conditions
Keywords
S-1,Oxaliplatin,Advanced or Recurrent Gastric Cancer
Brief summary
Elderly patients have poor tolerance and physical condition, we will prove 2-week schedule of oxaliplatin plus S-1 have a good efficacy and a better safety for elderly patients with advanced or recurrent gastric cancer.
Detailed description
3-week plan of S-1 plus Oxaliplatin has been widely used,but it also has cumulative toxicity.Meanwhile elderly patients have poor tolerance and physical condition, we will prove 2-weeks schedule of oxaliplatin plus S-1 have a good efficacy and a better safety for elderly patients with advanced or recurrent gastric cancer.Untreated elderly patients with advanced or recurrent gastric cancer will receive Oxaliplatin 85 mg/m2 (D1, q2w) and S-1(40mg BID for body surface area \< 1.25 m2; 50mg BID for body surface area of 1.25-1.5m2; and 60mg BID for body surface area \>1.5 m2; D1-10, q2w) as the first-line treatment. We will investigate the efficacy and safety of the combination treatment, and expect to provide a good effective treatment plan and a better safety for elderly patients with advanced or recurrent gastric cancer in China.The primary endpoint is progression-free survival(PFS), and the secondary endpoints are objective response rate(ORR), overall survival(OS) and the safety.
Interventions
DRUGS-1,Oxaliplatin
Oxaliplatin 85 mg/m2 (D1, q2w) and S-1 (40mg BID for body surface area \< 1.25 m2; 50mg BID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface area \>1.5 m2; D1-10, q2w)
Sponsors
Aiping Zhou
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single Group Assignment Eledrly Patients with Untreated Advanced or Recurrent Gastric Cancer
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed unresectable or recurrent gastric or gastroesophageal junction adenocarcinoma; * Aged≥60 * ability of oral administration; * CT or MRI can be used to assess measurable or non-measurable lesions according to the criteria of Response Evaluation Criteria In Solid Tumours (RECIST 1.1); * Untreated * more than 12 months after the last adjuvant/neoadjuvant chemotherapy; * ECOG=0-2; * Available organ function: ALT≤2.5xULN;AST≤2.5xULN;If patients have hepaticmetastasis,ALT≤2.5xULN,AST≤2.5xULN;ALP≤2xULN;TBIL≤1.0xULN;NEUT≥1.5×109/L;PLT≥100×109/L;Hb≥90g/L;Creatinine≤1.0xULN;Creatinine Clearance≥60ml/min * Informed consent; * Expected survival more than 3 months;More than 3 weeks after major surgery.
Exclusion criteria
* Neoadjuvant and/or adjuvant have been treated with more than two plans; * In the past two years, the total dose of oxaliplatin≥800mg/m2; * Other cancers in the past 5 years,except for cervical carcinoma in situ or non-melanoma skin cancer; * Symptomatic brain metastases or soft meningeal metastasis; * Myocardial infarction (in the last 6 months), severe instability angina, congestive heart failure; * Serious complications (including intestinal paralysis, gastrointestinal obstruction, interstitial pneumonia, pulmonary fibrosis, uncontrolled diabetes, renal insufficiency and cirrhosis); Chronic nausea, vomiting or diarrhea (more than 4 times per day, or watery);Gastrointestinal bleeding requires regular blood transfusion;HIV or AIDS; Mental illness; Neuropathy grade≥2;Infectious diseases or inflammation, temperature≥38℃; * Known allergy to drugs in the study; * Pregnant or lactating women; * Both male and female subjects of potential fertility have to agree effective birth control during the entire study; * Experimental drugs used no more than 4 weeks; * Other conditions the researchers considered ineligible for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 6 months | Progression-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR | 6 months | Objective response rate |
| OS | 1 year | Overall survival |
| The number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 1 year | Safety |
Countries
China
Contacts
Primary ContactAiping Zhou, Doctor
Outcome results
None listed