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

NCT ID: NCT01980407

Last Updated: 2015-03-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2016-03-31

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SOL, single arm

S-1 combined with leucovorin and oxaliplatin

Group Type: EXPERIMENTAL

S-1, leucovorin, oxaliplatin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

S-1 (20mg):Taiho Pharmaceutical Co., Ltd.； formyltetrahydrofolate (15mg); L-OHP (50mg)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jilin Provincial Tumor Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhang Yue

Head of Department of Integrated Traditional Chinese and Western Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jilin Provincial Tumor Hospital

Changchun, Jilin, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yue Zhang, MD, Ph.D

Role: CONTACT

JPCH2013@163.com

+86-0431-85872596

Other Identifiers

TOTMS1311

Identifier Type: -

Identifier Source: secondary_id

JPCH1301

Identifier Type: -

Identifier Source: org_study_id