Feasibility Study of SOL (S-1,Oral Leucovorin,and Oxaliplatin) in Patients With Advanced Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

A Safety and Efficacy Study of S-1, Oxaliplatin, and Leucovorin (SOL) in Patients With Advanced Gastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01980407
• Other study ID #: JPCH1301
• Secondary ID: TOTMS1311
• Status: Recruiting
• Phase: Phase 2
• First received: October 27, 2013
• Last updated: March 4, 2015
• Start date: November 2013
• Est. completion date: March 2016

Study information

• Verified date: November 2013
• Source: Jilin Provincial Tumor Hospital
• Contact: Yue Zhang, MD, Ph.D
• Phone: +86-0431-85872596
• Email: JPCH2013[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 49
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• S-1, leucovorin, oxaliplatin
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.

Locations

Country	Name	City	State
China	Jilin Provincial Tumor Hospital	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Jilin Provincial Tumor Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	Evaluate the objective response rate followed by RECIST 1.1.	6-8 weeks	No
Secondary	Adverse events	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.	1 year	Yes
Secondary	Overall survival		3 year	No
Secondary	Progress free survival	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.	up to 9 weeks	No
Secondary	Disease control rate	To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria	up to 9 weeks	No