Feasibility Study of SOL (S-1,Oral Leucovorin,and Oxaliplatin) in Patients With Advanced Gastric Cancer
- Registration Number
- NCT01980407
- Lead Sponsor
- Jilin Provincial Tumor Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 49
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SOL, single arm S-1, leucovorin, oxaliplatin S-1 combined with leucovorin and oxaliplatin
- Primary Outcome Measures
Name Time Method Response rate 6-8 weeks Evaluate the objective response rate followed by RECIST 1.1.
- Secondary Outcome Measures
Name Time Method 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.
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 Disease control rate up to 9 weeks To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria
Trial Locations
- Locations (1)
Jilin Provincial Tumor Hospital
🇨🇳Changchun, Jilin, China