Back to resultsStudy of Continuous or Intermittent S-1 Combined With Oxaliplatin in Recurrent or Metastatic Gastric Carcinoma
Primary Purpose
Stomach Neoplasms
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
S-1,oxaliplatin
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Neoplasms focused on measuring Stomach Neoplasms, Secondary, Combination chemotherapy, S-1, oxaliplatin
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed gastric adenocarcinoma with recurrent and/or metastatic disease
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) or non-measurable evaluable
- No prior treatment for recurrent and/or metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study; prior oxaliplatin is not allowed)
- Adequate major organ function including the following: Hematopoietic function: ANC >= 1,500/mm3, Platelet >= 100,000/mm3, Hepatic function: serum bilirubin =< 1.5 x ULN, AST/ALT levels =< 2.5 x ULN (=< 5 x ULN if liver metastases are present)Renal function: serum creatinine =< 1.5 x ULN
- Patients should sign a written informed consent before study entry
Exclusion Criteria:
- Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (e.g. patients with partial or total gastrectomy can enter the study, but not those with a jejunostomy probe), or inability to take oral medication
- Patients with active (significant or uncontrolled) gastrointestinal bleeding
- Residual relevant toxicity resulting from previous therapy (with the exception of alopecia) ≥ grade 2 NCI-CTCAE version 3.0
Prior and/or current history of peripheral neuropathy
- grade 1 NCI-CTCAE version 3.0
- Inadequate cardiovascular function:New York Heart Association class III or IV heart diseaseUnstable angina or myocardial infarction within the past 6 monthsHistory of significant ventricular arrhythmia requiring medication with antiarrhythmics or significant conduction system abnormality
- Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
- Other malignancy within the past 3 years except non-melanomatous skin cancer or carcinoma in situ of the cervix
- History of or current brain metastases
- Psychiatric disorder that would preclude compliance
- Females with a positive or no pregnancy test (within 7 days before treatment start) until childbearing potential can be otherwise excluded (postmenopausal i.e. amenorrheic for at least 2 years, hysterectomy or oophorectomy)
- Subjects with reproductive potential not willing to use an effective method of contraception
- Lactating women
- Known dihydropyrimidine dehydrogenase deficiency
- Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine, phenytoin, or warfarin et al.
- Major surgery within 4 weeks of start of study treatment, without complete recovery
- Radiotherapy within 4 weeks of start of study treatment; 2 weeks interval allowed if palliative radiotherapy was given to bone metastatic site and patient recovered from any acute toxicity
Sites / Locations
- National Cancer Center KoreaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
A
B
Arm Description
(continuous):S-1 plus oxalipatin will be continued until disease progression, unacceptable toxicity or consent withdrawal.
(intermittent arm): Treatment will be stopped after the initial 6 cycles of S-1 plus oxaliplatin, and then S-1 plus oxaliplatin will be resumed at the disease progression during follow-up, as the same dose as the last chemotherapy of initial 6 cycles.
Outcomes
Primary Outcome Measures
Overall survial in the two treatment arms
Secondary Outcome Measures
Response rate, toxicity, duration of response, time to progression, Quality of life in the two treatment arms,the effect of CYP2A6 genetic polymorphisms on the pharmacokinetics, treatment efficacy and toxicity
Full Information
NCT ID
NCT00515190
First Posted
August 10, 2007
Last Updated
December 21, 2007
Sponsor
National Cancer Center, Korea
1. Study Identification
Unique Protocol Identification Number
NCT00515190
Brief Title
Study of Continuous or Intermittent S-1 Combined With Oxaliplatin in Recurrent or Metastatic Gastric Carcinoma
Official Title
A Randomized Phase II Study of Continuous or Intermittent S-1 Combined With Oxaliplatin in Recurrent or Metastatic Gastric Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Unknown status
Study Start Date
July 2007 (undefined)
Primary Completion Date
August 2010 (Anticipated)
Study Completion Date
August 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
National Cancer Center, Korea
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Randomized phase II study designed to evaluate the efficacy and safety of continuous S-1 plus oxaliplatin versus intermittent S-1 plus oxaliplatin as first-line therapy in patients with recurrent and/or metastastic gastric carcinoma. Within 2 weeks of the end of induction chemotherapy of 6 cycles with S-1 plus oxalipatin, patients who don't experience progression will be randomized to the continuous S-1 plus oxaliplatin arm or the intermittent S-1 plus oxaliplatin arm in a 1:1 ratio.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms
Keywords
Stomach Neoplasms, Secondary, Combination chemotherapy, S-1, oxaliplatin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
198 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
(continuous):S-1 plus oxalipatin will be continued until disease progression, unacceptable toxicity or consent withdrawal.
Arm Title
B
Arm Type
Active Comparator
Arm Description
(intermittent arm): Treatment will be stopped after the initial 6 cycles of S-1 plus oxaliplatin, and then S-1 plus oxaliplatin will be resumed at the disease progression during follow-up, as the same dose as the last chemotherapy of initial 6 cycles.
Intervention Type
Drug
Intervention Name(s)
S-1,oxaliplatin
Intervention Description
Arm A (continuous arm): S-1 80mg/m2/d p.o. twice daily(q 12-h)on D1(evening)-D15(morning)plus oxaliplatin 130mg/m2 IV(in the vein)on D1 every 3 weeks, until disease progression, unacceptable toxicity, or consent withdrawal.
Arm B (intermittent arm):Treatment will be stopped after the initial 6 cycles of S-1 plus oxaliplatin, and then S-1 plus oxaliplatin will be resumed at the disease progression during follow-up, as the same dose as the last chemotherapy of initial 6 cycles.
Primary Outcome Measure Information:
Title
Overall survial in the two treatment arms
Time Frame
During study period
Secondary Outcome Measure Information:
Title
Response rate, toxicity, duration of response, time to progression, Quality of life in the two treatment arms,the effect of CYP2A6 genetic polymorphisms on the pharmacokinetics, treatment efficacy and toxicity
Time Frame
During study period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed gastric adenocarcinoma with recurrent and/or metastatic disease
Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) or non-measurable evaluable
No prior treatment for recurrent and/or metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study; prior oxaliplatin is not allowed)
Adequate major organ function including the following: Hematopoietic function: ANC >= 1,500/mm3, Platelet >= 100,000/mm3, Hepatic function: serum bilirubin =< 1.5 x ULN, AST/ALT levels =< 2.5 x ULN (=< 5 x ULN if liver metastases are present)Renal function: serum creatinine =< 1.5 x ULN
Patients should sign a written informed consent before study entry
Exclusion Criteria:
Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (e.g. patients with partial or total gastrectomy can enter the study, but not those with a jejunostomy probe), or inability to take oral medication
Patients with active (significant or uncontrolled) gastrointestinal bleeding
Residual relevant toxicity resulting from previous therapy (with the exception of alopecia) ≥ grade 2 NCI-CTCAE version 3.0
Prior and/or current history of peripheral neuropathy
grade 1 NCI-CTCAE version 3.0
Inadequate cardiovascular function:New York Heart Association class III or IV heart diseaseUnstable angina or myocardial infarction within the past 6 monthsHistory of significant ventricular arrhythmia requiring medication with antiarrhythmics or significant conduction system abnormality
Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
Other malignancy within the past 3 years except non-melanomatous skin cancer or carcinoma in situ of the cervix
History of or current brain metastases
Psychiatric disorder that would preclude compliance
Females with a positive or no pregnancy test (within 7 days before treatment start) until childbearing potential can be otherwise excluded (postmenopausal i.e. amenorrheic for at least 2 years, hysterectomy or oophorectomy)
Subjects with reproductive potential not willing to use an effective method of contraception
Lactating women
Known dihydropyrimidine dehydrogenase deficiency
Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine, phenytoin, or warfarin et al.
Major surgery within 4 weeks of start of study treatment, without complete recovery
Radiotherapy within 4 weeks of start of study treatment; 2 weeks interval allowed if palliative radiotherapy was given to bone metastatic site and patient recovered from any acute toxicity
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sook Ryun Park, M.D.
Phone
+82-31-920-1609
Email
sukryun73@ncc.re.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Se Youn Jang, M.S.
Phone
+82-+31-920-0667
Email
jj96smc@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sook Ryun Park, M.D.
Organizational Affiliation
National Cancer Center, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center Korea
City
Goyang
State/Province
Gyeonggi
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sook Ryun Park, M.D.
Phone
+82-31-920-1609
Email
sukryun73@ncc.re.kr
First Name & Middle Initial & Last Name & Degree
Se Youn Jang, M.S.
Phone
+82-31-920-0667
Email
jj96smc@naver.com
First Name & Middle Initial & Last Name & Degree
Neo Kyenong Kim, M.D.Ph.D
First Name & Middle Initial & Last Name & Degree
Young Iee Park, M,D.Ph.D
First Name & Middle Initial & Last Name & Degree
Jong Seok Lee, M.D.
First Name & Middle Initial & Last Name & Degree
Byung-Ho Nam, M.D.Ph.D
First Name & Middle Initial & Last Name & Degree
Young-Ho Yun, M.D.
12. IPD Sharing Statement
Learn more about this trial
Study of Continuous or Intermittent S-1 Combined With Oxaliplatin in Recurrent or Metastatic Gastric Carcinoma
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