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Study of S-1 Plus LV for Advanced Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
S-1
LV
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Advance Gastric Cancer,, S-1 plus leucovorin,, ORR,, OS,, TTP,, TTF,, Adverse events,, Pharmacokinetics

Eligibility Criteria

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

Inclusion Criteria:

  • histologically confirmed metastatic or recurrent gastric cancer
  • with at least one measurable lesion by RECIST criteria
  • an age of ≥ 18
  • adequate oral intake
  • no previous radiotherapy, immunotherapy, biotherapy, hormonotherapy and chemotherapy within 5 years (adjuvant chemotherapy without S-1 was allowed if finished 6 months before enrollment)
  • an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • adequate bone marrow function, hepatic function and renal functions

Exclusion Criteria:

  • a history of hypersensitivity to S-1 or LV, usage of drugs interacting with S-1
  • serious concomitant conditions (severe heart disease, pulmonary fibrosis, intestinal obstruction, enteroplegia, renal failure, liver failure, pre-existing sensory neuropathy ≥ grade 2, uncontrolled infections, psychogenic disorders, human immunodeficiency virus infection, severe diarrhea, nausea, or vomiting, severe ascites or pleural effusion, etc.)
  • extensive bone metastasis, brain metastasis or meningeal metastasis
  • another synchronous cancer
  • surgery within 3 weeks before enrollment
  • participating in other clinical studies
  • women who were or to be pregnant, nursing infants, and men who were to conceive children

Sites / Locations

  • Sun Yat-sen University Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

S-1 plus LV

Arm Description

All patients were orally treated with S-1 in doses of 40 mg (body surface area (BSA)<1.25 m2), 50 mg (1.25≤BSA<1.50 m2) and 60 mg (BSA≥1.50 m2) b.i.d. on days 1-7 in combination with LV given simultaneously at a fixed dose of 25 mg b.i.d. on days 1-7, followed by a 7 day rest. Treatment courses were repeated every 2 weeks.

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR)
The primary endpoint is overall response rate,which equals the rate of patients with CR+PR.

Secondary Outcome Measures

Progression free survival (PFS)
Progression-free survival (PFS) was determined from the date of treatment to progression or death
Overall survival (OS)
Overall survival (OS) was calculated from the date of treatment to death from any cause or the last date of follow-up.
Time to treatment failure (TTF)
Time to treatment failure (TTF) was determined from the date of treatment to progression, death, refusal or interruption due to adverse events.
Disease control rate
Disease control rate equals the rate of patients with CR+PR+SD.
Adverse Events (AEs)
All treatment-related adverse events (AEs) were categorized according to the National Cancer Institute's Common Terminology Criteria for Adverse Events.

Full Information

First Posted
March 12, 2014
Last Updated
March 14, 2014
Sponsor
Sun Yat-sen University
Collaborators
Taiho Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02090153
Brief Title
Study of S-1 Plus LV for Advanced Gastric Cancer
Official Title
Phase II Study of S-1 Plus Leucovorin (1 Week on and 1 Week Off) as First-line Treatment for Patients With Metastatic and Recurrent Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Taiho Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of S-1 plus Leucovorin (1 week on and 1 week off) as first-line treatment for patients with metastatic and recurrent gastric cancer.
Detailed Description
Patients enrolled in this study were orally treated with S-1 in doses of 40 mg (body surface area (BSA)<1.25 m2), 50 mg (1.25≤BSA<1.50 m2) and 60 mg (BSA≥1.50 m2) b.i.d. on days 1-7 in combination with LV given simultaneously at a fixed dose of 25 mg b.i.d. on days 1-7, followed by a 7 day rest. Treatment courses were repeated every 2 weeks. Treatment was continued until progressive disease (PD), unacceptable toxicity or patient refusal.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Advance Gastric Cancer,, S-1 plus leucovorin,, ORR,, OS,, TTP,, TTF,, Adverse events,, Pharmacokinetics

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
S-1 plus LV
Arm Type
Experimental
Arm Description
All patients were orally treated with S-1 in doses of 40 mg (body surface area (BSA)<1.25 m2), 50 mg (1.25≤BSA<1.50 m2) and 60 mg (BSA≥1.50 m2) b.i.d. on days 1-7 in combination with LV given simultaneously at a fixed dose of 25 mg b.i.d. on days 1-7, followed by a 7 day rest. Treatment courses were repeated every 2 weeks.
Intervention Type
Drug
Intervention Name(s)
S-1
Other Intervention Name(s)
tegafur/gimeracil/oteracil potassium
Intervention Description
40~60mg bid，d1~7 q2W
Intervention Type
Drug
Intervention Name(s)
LV
Other Intervention Name(s)
Leucovorin
Intervention Description
LV is given simultaneously at a fixed dose of 25 mg b.i.d. on days 1-7, followed by a 7 day rest.
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
The primary endpoint is overall response rate,which equals the rate of patients with CR+PR.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
Progression-free survival (PFS) was determined from the date of treatment to progression or death
Time Frame
1-1.5 years
Title
Overall survival (OS)
Description
Overall survival (OS) was calculated from the date of treatment to death from any cause or the last date of follow-up.
Time Frame
1-2.5 years
Title
Time to treatment failure (TTF)
Description
Time to treatment failure (TTF) was determined from the date of treatment to progression, death, refusal or interruption due to adverse events.
Time Frame
1 year
Title
Disease control rate
Description
Disease control rate equals the rate of patients with CR+PR+SD.
Time Frame
1 year
Title
Adverse Events (AEs)
Description
All treatment-related adverse events (AEs) were categorized according to the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: histologically confirmed metastatic or recurrent gastric cancer with at least one measurable lesion by RECIST criteria an age of ≥ 18 adequate oral intake no previous radiotherapy, immunotherapy, biotherapy, hormonotherapy and chemotherapy within 5 years (adjuvant chemotherapy without S-1 was allowed if finished 6 months before enrollment) an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 adequate bone marrow function, hepatic function and renal functions Exclusion Criteria: a history of hypersensitivity to S-1 or LV, usage of drugs interacting with S-1 serious concomitant conditions (severe heart disease, pulmonary fibrosis, intestinal obstruction, enteroplegia, renal failure, liver failure, pre-existing sensory neuropathy ≥ grade 2, uncontrolled infections, psychogenic disorders, human immunodeficiency virus infection, severe diarrhea, nausea, or vomiting, severe ascites or pleural effusion, etc.) extensive bone metastasis, brain metastasis or meningeal metastasis another synchronous cancer surgery within 3 weeks before enrollment participating in other clinical studies women who were or to be pregnant, nursing infants, and men who were to conceive children
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruihua Xu, Professor
Organizational Affiliation
SunYat-sen University Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Gaungzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
19828562
Citation
Koizumi W, Boku N, Yamaguchi K, Miyata Y, Sawaki A, Kato T, Toh Y, Hyodo I, Nishina T, Furuhata T, Miyashita K, Okada Y. Phase II study of S-1 plus leucovorin in patients with metastatic colorectal cancer. Ann Oncol. 2010 Apr;21(4):766-771. doi: 10.1093/annonc/mdp371. Epub 2009 Oct 14.
Results Reference
background
PubMed Identifier
27913881
Citation
He MM, Zhang DS, Wang F, Wang ZX, Yuan SQ, Wang ZQ, Luo HY, Ren C, Qiu MZ, Jin Y, Wang DS, Chen DL, Zeng ZL, Li YH, He YY, Hao YT, Guo P, Wang FH, Zeng YX, Xu RH. Phase II trial of S-1 plus leucovorin in patients with advanced gastric cancer and clinical prediction by S-1 pharmacogenetic pathway. Cancer Chemother Pharmacol. 2017 Jan;79(1):69-79. doi: 10.1007/s00280-016-3209-1. Epub 2016 Dec 2.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/23999902
Description
Long-term outcomes and prognostic factors of patients with advanced gastric cancer treated with S-1 plus cisplatin combination chemotherapy as a first-line treatment.
URL
http://www.ncbi.nlm.nih.gov/pubmed/24349363
Description
S-1-Based Chemotherapy versus Capecitabine-Based Chemotherapy as First-Line Treatment for Advanced Gastric Carcinoma: A Meta-Analysis.

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Study of S-1 Plus LV for Advanced Gastric Cancer

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