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

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
S-1, leucovorin, oxaliplatin
Sponsored by
Jilin Provincial Tumor Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring S-1, Oxaliplatin, Leucovorin, Gastric Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jilin Provincial Tumor HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SOL, single arm

Arm Description

S-1 combined with leucovorin and oxaliplatin

Outcomes

Primary Outcome Measures

Response rate
Evaluate the objective response rate followed by RECIST 1.1.

Secondary Outcome Measures

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.
Overall survival
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.
Disease control rate
To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria

Full Information

First Posted
October 27, 2013
Last Updated
March 4, 2015
Sponsor
Jilin Provincial Tumor Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01980407
Brief Title
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

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
March 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jilin Provincial Tumor Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
S-1, Oxaliplatin, Leucovorin, Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SOL, single arm
Arm Type
Experimental
Arm Description
S-1 combined with leucovorin and oxaliplatin
Intervention Type
Drug
Intervention Name(s)
S-1, leucovorin, oxaliplatin
Other Intervention Name(s)
S-1 (20mg):Taiho Pharmaceutical Co., Ltd.；, formyltetrahydrofolate (15mg), L-OHP (50mg)
Intervention 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.
Primary Outcome Measure Information:
Title
Response rate
Description
Evaluate the objective response rate followed by RECIST 1.1.
Time Frame
6-8 weeks
Secondary Outcome Measure Information:
Title
Adverse events
Description
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.
Time Frame
1 year
Title
Overall survival
Time Frame
3 year
Title
Progress free survival
Description
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.
Time Frame
up to 9 weeks
Title
Disease control rate
Description
To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria
Time Frame
up to 9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yue Zhang, MD, Ph.D
Phone
+86-0431-85872596
Email
JPCH2013@163.com
Facility Information:
Facility Name
Jilin Provincial Tumor Hospital
City
Changchun
State/Province
Jilin
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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