Gastric Cancer
Conditions
Keywords
S-1, Oxaliplatin, Leucovorin, Gastric Cancer
Brief summary
In China, S-1 is an novel oral fluoropyrimidine with demonstrated high efficacy on gastrointestinal cancer. The new regimen with oxaliplatin and leucovorin is expected to achieve more encouraging efficacy on gastric cancer. This study is aimed to evaluate the feasibility of the SOL regimen on efficacy and tolerability on Chinese patients with advanced gastric cancer.
Interventions
S-1 (20mg), capsule, 40-60mg, bid, p.o., day1-14； Leucovorin (15 mg), tablet, 30mg,Bid, p.o., day1-14; Oxaliplatin (50 mg), injection 85mg/m2, day1.
Sponsors
Jilin Provincial Tumor Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age over 18 years old * Histologically or cytologically documented gastric adenocarcinoma * Performance status (ECOG scale): 0-2 * Life expectancy ≥ 3 months * No previous treatment(including: radiotherapy,chemotherapy and immunotherapy) * Prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive immunotherapy) for adjuvant or neoadjuvant treatment for non-metastatic (M0) disease has been completed within 6 months prior to initiation of study treatment. * WIth Measurable Target lesion * Patients should sign a written informed consent before study entry
Exclusion criteria
* History of hypersensitivity to fluoropyrimidines, S-1, oxaliplatin or the ingredients product * Inadequate hematopoietic function: WBC≦5,000/mm3; ANC≦2,000/mm3; Platelet≦100,000/mm3 * Inadequate organ function which is defined as below: Total bilirubin \>2 pper limit of normal range (ULN); ALT / AST \> 2.5 upper limit of normal range (ULN) (\>5.0 x ULN if hepatic metastasis); serum creatinine \> 2 upper limit of normal range (ULN); * Symptomatic peripheral neuropathy ≥ NCI CTC AE grade 1; * Receiving a concomitant treatment with other fluoropyrimidines or fluorocytosine; * Pregnancy or lactation women, or women with suspected pregnancy or men unless using a reliable and appropriate contraceptive method; * Mental status is not fit for chemotherapy therapy presence of serious concomitant illness which might be aggravated by study medication; * History of ventricular arrhythmia or congestive heart failure; * Active cardiac disease e.g. decompensate myocardial infarction within the 6-month period preceding entry into the study; * Significant co-morbid medical conditions, including, but not limited to, Chronic obstructive pulmonary disease, interstitial pneumonia ,pulmonary heart failure, renal failure, hepatic failure, haemorrhagic peptic ulcer, mechanical, paralytic or poor control diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | 6-8 weeks | Evaluate the objective response rate followed by RECIST 1.1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 1 year | Investigators graded all adverse events and toxic effects according to the National Cancer Institute's Common Toxicity Criteria, The number of Participants with adverse events will be recorded at each treatment visit. |
| Overall survival | 3 year | — |
| Progress free survival | up to 9 weeks | Tumor assessment will be performed every 3 cycles (9 weeks) from the start of treatment until progression or as for the metastatic site developed during the study (including clinical suspicion). In order to confirm objective tumor response, additional confirmatory scan should be obtained at least 4 weeks following the first radiological evidence of tumor response. |
| Disease control rate | up to 9 weeks | To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria |
Countries
China
Contacts
Primary ContactYue Zhang, MD, Ph.D
Outcome results
None listed