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Trial Title:
Feasibility Study of SOL (S-1,Oral Leucovorin,and Oxaliplatin) in Patients With Advanced Gastric Cancer
NCT ID:
NCT01980407
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Leucovorin
Formyltetrahydrofolates
Oxaliplatin
Conditions: Keywords:
S-1
Oxaliplatin
Leucovorin
Gastric Cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
S-1, leucovorin, oxaliplatin
Description:
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.
Arm group label:
SOL, single arm
Other name:
S-1 (20mg):Taiho Pharmaceutical Co., Ltd.；
Other name:
formyltetrahydrofolate (15mg)
Other name:
L-OHP (50mg)
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Jilin Provincial Tumor Hospital
Address:
City:
Changchun
Country:
China
Status:
Recruiting
Start date:
November 2013
Completion date:
March 2016
Lead sponsor:
Agency:
Jilin Provincial Tumor Hospital
Agency class:
Other
Source:
Jilin Provincial Tumor Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01980407
