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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2012 by Kyungpook National University
Sponsor:
Information provided by (Responsible Party):
Byung Woog Kang, Kyungpook National University
ClinicalTrials.gov Identifier:
NCT01426646
First received: January 18, 2011
Last updated: January 3, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
Drug: S-1
Drug: S-1 plus cisplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Kyungpook National University:

Primary Outcome Measures:
  • Relapse-free survival [ Time Frame: 3 years from enrollment. ] [ Designated as safety issue: No ]
    RFS was defined as the time from the date of surgery to relapse or death from any cause.


Secondary Outcome Measures:
  • Overall survival [ Time Frame: 3 years from enrollment. ] [ Designated as safety issue: No ]
    OS was defined as the time from the date of surgery to death from any cause.


Estimated Enrollment: 218
Study Start Date: September 2011
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: S-1 treatment
S-1 was administered at 40mg/m2 orally twice daily (days 1-28) every 42 days. Patients received a maximum of eight cycles.
Drug: S-1
S-1 was administered at 40mg/m2 orally twice daily (days 1-28) every 42 days. Patients received a maximum of eight cycles.
Other Name: TS-1
Experimental: S-1 plus cisplatin treatment

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
Drug: S-1 plus cisplatin

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
Other Names:
  • TS-1
  • cisplatin

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18-70 years
  2. Histologically proven adenocarcinoma of the stomach
  3. Curative D2 lymphadenectomy resection for gastric cancer, who can be randomized to either study arm within 6 weeks after surgery
  4. Stage II, III and IV (M0)(AJCC 7th edition)
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  6. No prior chemotherapy or radiotherapy
  7. Adequate bone marrow, renal, and liver function

Exclusion Criteria:

  1. Pregnant or lactating women.
  2. 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.
  3. Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
  4. Any evidence of metastatic disease (including presence of tumor cells in the ascites).
  5. Previous cytotoxic chemotherapy, radiotherapy or immunotherapy except corticosteroids, for the currently treated gastric cancer.
  6. Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery.
  7. 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.

  8. 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.
  9. Organ allografts requiring immunosuppressive therapy.
  10. Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease.
  11. 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.

  12. Received any investigational drug or agent/procedure, i.e. participation in another trial, within 4 weeks before randomization.
  13. Blood transfusions or growth factors to aid hematologic recovery within 2 weeks prior to study treatment start.
  14. Requirement for concurrent use of the antiviral agent sorivudine (antiviral) or chemically related analogues, such as brivudine.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01426646

Contacts
Contact: Byung Woog Kang, Professor +82-10-9216-2633 bwkang@knu.ac.kr

Locations
Korea, Republic of
Donga university hospital Recruiting
Busan, Korea, Republic of, 602-715
Contact: Hyuk-Chan Kwon, Professor         
Principal Investigator: Hyuk-Chan Kwon, Professor         
Ulsan University Hospital Recruiting
Ulsan, Korea, Republic of, 682-714
Contact: Jin Ho Baek, Professor         
Principal Investigator: Jin-Ho Baek, Professor         
Sponsors and Collaborators
Kyungpook National University
Investigators
Principal Investigator: Wansik Yu, Professor Kyungpook National University
  More Information

No publications provided

Responsible Party: Byung Woog Kang, Professor(full time instructor), Kyungpook National University
ClinicalTrials.gov Identifier: NCT01426646     History of Changes
Other Study ID Numbers: ACSPGC-01
Study First Received: January 18, 2011
Last Updated: January 3, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Kyungpook National University:
gastric cancer
S-1
cisplatin
adjuvant chemotherapy

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 30, 2014