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S-1 Versus S-1 Plus Cisplatin as an Adjuvant Chemotherapy to Treat Gastric Cancer

Primary Purpose

Gastric Cancer

Status

Unknown status

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

S-1

S-1 plus cisplatin

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, S-1, cisplatin, adjuvant chemotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18-70 years
Histologically proven adenocarcinoma of the stomach
Curative D2 lymphadenectomy resection for gastric cancer, who can be randomized to either study arm within 6 weeks after surgery
Stage II, III and IV (M0)(AJCC 7th edition)
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
No prior chemotherapy or radiotherapy
Adequate bone marrow, renal, and liver function

Exclusion Criteria:

Pregnant or lactating women.
Women of childbearing potential with either a positive or no pregnancy test at baseline. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-child bearing potential.
Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
Any evidence of metastatic disease (including presence of tumor cells in the ascites).
Previous cytotoxic chemotherapy, radiotherapy or immunotherapy except corticosteroids, for the currently treated gastric cancer.
Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery.
History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix.
Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months.
Lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome likely to influence absorption of capecitabine, or inability to take oral medication.
Organ allografts requiring immunosuppressive therapy.
Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease.
Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented dihydropyrimidine dehydrogenase (DPD) deficiency) or patients with known DPD deficiency.
Hypersensitivity to platinum compounds or any of the components of the study medications.
Received any investigational drug or agent/procedure, i.e. participation in another trial, within 4 weeks before randomization.
Blood transfusions or growth factors to aid hematologic recovery within 2 weeks prior to study treatment start.
Requirement for concurrent use of the antiviral agent sorivudine (antiviral) or chemically related analogues, such as brivudine.

Sites / Locations

Donga university hospitalRecruiting
Ulsan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

S-1 treatment

S-1 plus cisplatin treatment

Arm Description

S-1 was administered at 40mg/m2 orally twice daily (days 1-28) every 42 days. Patients received a maximum of eight cycles.

S-1 plus cisplatin every 3 weeks, A total of eight cycles S-1: 40mg/m2 orally twice daily (days 1-14) Cisplatin: 60mg/m2 IV on day 1

Outcomes

Primary Outcome Measures

Relapse-free survival

RFS was defined as the time from the date of surgery to relapse or death from any cause.

Secondary Outcome Measures

Overall survival

OS was defined as the time from the date of surgery to death from any cause.

Full Information

NCT ID

NCT01426646

First Posted

January 18, 2011

Last Updated

January 3, 2012

Sponsor

Kyungpook National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01426646

Brief Title

S-1 Versus S-1 Plus Cisplatin as an Adjuvant Chemotherapy to Treat Gastric Cancer

Official Title

Randomized Multicenter Phase II Trial of S-1 Versus S-1 Plus Cisplatin as an Adjuvant Chemotherapy After Curative Resection of Stage II-IV(M0) Gastric Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Unknown status

Study Start Date

September 2011 (undefined)

Primary Completion Date

September 2014 (Anticipated)

Study Completion Date

September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kyungpook National University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Although there has been some progress in chemotherapy for metastatic gastric cancer, no standard regimen of adjuvant chemotherapy is available, and many clinical trials have produced contradictory results. The majority of randomized clinical trials studying adjuvant chemotherapy in gastric cancer have been underpowered, involved low-volume centers, or used ineffective chemotherapy regimens. As a result, well-designed multicenter trials are still needed. The ACTS-GC trial, which demonstrated the efficacy of S-1 for stage II-III gastric cancer patients who underwent curative resection with extended lymph-node dissection (D2), may be valid in countries where D2 surgery is considered the standard of care. S-1 improved the 3-year overall survival from 70.1% for surgery alone to 80.1%. However, 3-year overall survival in stage IIIA and stage IIIB patients receiving S-1 were 77.4% and 63.4%, respectively, which are less satisfactory compared to the rate for stage II (90.7%). Based on the unsatisfactory outcome among later stage patients in the ACTS-GC adjuvant trial, further investigation is needed for more effective postoperative treatment of patients with stage IIIB and IV (M0) cancer. Therefore, the researchers investigated the efficacy and safety of S-1 versus S-1 plus cisplatin as adjuvant chemotherapy in patient with curatively resected gastric adenocarcinoma.

Detailed Description

This controlled study is designed to evaluate the efficacy of S-1 on survival compared with S-1 plus cisplatin. Patients will be randomly assigned to receive either surgery followed by treatment with S-1 plus cisplatin or surgery followed by treatment with S-1 within 42 days after curative resection. To assess the efficacy, data on recurrence and survival will be collected from the time of enrollment until 5 years after surgery. To evaluate safety, data on adverse events will be collected from the time of enrollment until 1 year after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

Keywords

gastric cancer, S-1, cisplatin, adjuvant chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

218 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

S-1 treatment

Arm Type

Experimental

Arm Description

S-1 was administered at 40mg/m2 orally twice daily (days 1-28) every 42 days. Patients received a maximum of eight cycles.

Arm Title

S-1 plus cisplatin treatment

Arm Type

Experimental

Arm Description

S-1 plus cisplatin every 3 weeks, A total of eight cycles S-1: 40mg/m2 orally twice daily (days 1-14) Cisplatin: 60mg/m2 IV on day 1

Intervention Type

Drug

Intervention Name(s)

S-1

Other Intervention Name(s)

TS-1

Intervention Description

S-1 was administered at 40mg/m2 orally twice daily (days 1-28) every 42 days. Patients received a maximum of eight cycles.

Intervention Type

Drug

Intervention Name(s)

S-1 plus cisplatin

Other Intervention Name(s)

TS-1, cisplatin

Intervention Description

S-1 plus cisplatin every 3 weeks, a total of eight cycles S-1: 40mg/m2 orally twice daily (days 1-14) Cisplatin: 60mg/m2 IV on day 1

Primary Outcome Measure Information:

Title

Relapse-free survival

Description

RFS was defined as the time from the date of surgery to relapse or death from any cause.

Time Frame

3 years from enrollment.

Secondary Outcome Measure Information:

Title

Overall survival

Description

OS was defined as the time from the date of surgery to death from any cause.

Time Frame

3 years from enrollment.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18-70 years Histologically proven adenocarcinoma of the stomach Curative D2 lymphadenectomy resection for gastric cancer, who can be randomized to either study arm within 6 weeks after surgery Stage II, III and IV (M0)(AJCC 7th edition) Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 No prior chemotherapy or radiotherapy Adequate bone marrow, renal, and liver function Exclusion Criteria: Pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test at baseline. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-child bearing potential. Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study. Any evidence of metastatic disease (including presence of tumor cells in the ascites). Previous cytotoxic chemotherapy, radiotherapy or immunotherapy except corticosteroids, for the currently treated gastric cancer. Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery. History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix. Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months. Lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome likely to influence absorption of capecitabine, or inability to take oral medication. Organ allografts requiring immunosuppressive therapy. Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease. Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented dihydropyrimidine dehydrogenase (DPD) deficiency) or patients with known DPD deficiency. Hypersensitivity to platinum compounds or any of the components of the study medications. Received any investigational drug or agent/procedure, i.e. participation in another trial, within 4 weeks before randomization. Blood transfusions or growth factors to aid hematologic recovery within 2 weeks prior to study treatment start. Requirement for concurrent use of the antiviral agent sorivudine (antiviral) or chemically related analogues, such as brivudine.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Byung Woog Kang, Professor

Phone

+82-10-9216-2633

bwkang@knu.ac.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wansik Yu, Professor

Organizational Affiliation

Kyungpook National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Donga university hospital

City

Busan

ZIP/Postal Code

602-715

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hyuk-Chan Kwon, Professor

First Name & Middle Initial & Last Name & Degree

Hyuk-Chan Kwon, Professor

Facility Name

Ulsan University Hospital

City

Ulsan

ZIP/Postal Code

682-714

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jin Ho Baek, Professor

First Name & Middle Initial & Last Name & Degree

Jin-Ho Baek, Professor

12. IPD Sharing Statement

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S-1 Versus S-1 Plus Cisplatin as an Adjuvant Chemotherapy to Treat Gastric Cancer

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