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

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ClinicalTrials.gov Identifier: NCT01980407
Recruitment Status : Unknown
Verified November 2013 by Zhang Yue, Jilin Provincial Tumor Hospital.
Recruitment status was:  Recruiting
First Posted : November 11, 2013
Last Update Posted : March 5, 2015
Sponsor:
Information provided by (Responsible Party):
Zhang Yue, Jilin Provincial Tumor Hospital

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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: S-1, leucovorin, oxaliplatin Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 49 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Safety and Efficacy Study of S-1, Oxaliplatin, and Leucovorin (SOL) in Patients With Advanced Gastric Cancer
Study Start Date : November 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

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)




Primary Outcome Measures :
  1. Response rate [ Time Frame: 6-8 weeks ]
    Evaluate the objective response rate followed by RECIST 1.1.


Secondary Outcome Measures :
  1. 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.

  2. Overall survival [ Time Frame: 3 year ]
  3. 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.

  4. Disease control rate [ Time Frame: up to 9 weeks ]
    To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01980407


Contacts
Contact: Yue Zhang, MD, Ph.D +86-0431-85872596 JPCH2013@163.com

Locations
China, Jilin
Jilin Provincial Tumor Hospital Recruiting
Changchun, Jilin, China
Sponsors and Collaborators
Jilin Provincial Tumor Hospital

Responsible Party: Zhang Yue, Head of Department of Integrated Traditional Chinese and Western Medicine, Jilin Provincial Tumor Hospital
ClinicalTrials.gov Identifier: NCT01980407     History of Changes
Other Study ID Numbers: JPCH1301
TOTMS1311
First Posted: November 11, 2013    Key Record Dates
Last Update Posted: March 5, 2015
Last Verified: November 2013

Keywords provided by Zhang Yue, Jilin Provincial Tumor Hospital:
S-1
Oxaliplatin
Leucovorin
Gastric Cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Oxaliplatin
Formyltetrahydrofolates
Antineoplastic Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs