Clinical trial NCT01980407: Feasibility Study of SOL (S-1,Oral Leucovorin,and Oxaliplatin) in Patients With Advanced Gastric Cancer
Official title: A Safety and Efficacy Study of S-1, Oxaliplatin, and Leucovorin (SOL) in Patients With Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: S-1
Oxaliplatin
Leucovorin
Gastric Cancer
Lead sponsor: Jilin Provincial Tumor Hospital
Sponsor class: OTHER
First posted: 2013-11-11
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Response rate
timeFrame: 6-8 weeks
Secondary outcomes:
measure: Adverse events
timeFrame: 1 year
measure: Overall survival
timeFrame: 3 year
measure: Progress free survival
timeFrame: up to 9 weeks
measure: Disease control rate
timeFrame: up to 9 weeks
Other outcomes:
Locations:
city: Changchun
country: China
facility: Jilin Provincial Tumor Hospital
state: Jilin
Study officials:
References: