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

March 4, 2015 updated by: Zhang Yue, Jilin Provincial Tumor Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

49

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yue Zhang, MD, Ph.D
  • Phone Number: +86-0431-85872596
  • Email: JPCH2013@163.com

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • Jilin Provincial Tumor Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SOL, single arm
S-1 combined with leucovorin and oxaliplatin
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.
Other Names:
  • S-1 (20mg):Taiho Pharmaceutical Co., Ltd.；
  • formyltetrahydrofolate (15mg)
  • L-OHP (50mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate
Time Frame: 6-8 weeks
Evaluate the objective response rate followed by RECIST 1.1.
6-8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 3 year
3 year
Adverse events
Time Frame: 1 year
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
Progress free survival
Time Frame: up to 9 weeks
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
Disease control rate
Time Frame: up to 9 weeks
To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria
up to 9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jilin Provincial Tumor Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2015

Study Completion (ANTICIPATED)

March 1, 2016

Study Registration Dates

First Submitted

October 27, 2013

First Submitted That Met QC Criteria

November 4, 2013

First Posted (ESTIMATE)

November 11, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 5, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JPCH1301
  • TOTMS1311

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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