S-1 and Cisplatin (3 Weekly) Versus S-1 and Oxaliplatin Combination Chemotherapy for Advanced Gastric Cancer

Gastric Cancer Clinical Trial

— SOPP  

Official title:

Phase III Trial of S-1 and Cisplatin (3 Weekly) Versus S-1 and Oxaliplatin Combination Chemotherapy for First Line Treatment of Advanced Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01671449
• Other study ID #: AMC-ONCGI-1202
• Status: Completed
• Phase: Phase 3
• First received: August 17, 2012
• Last updated: November 26, 2015
• Start date: December 2012
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review BoardSouth Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

A multicenter, randomized, open-label, phase III trial of S-1 plus cisplatin (3 weekly) versus S-1 plus oxaliplatin chemotherapy for the first-line treatment of advanced gastric cancer

Recruitment information / eligibility

• Status: Completed
• Enrollment: 338
• Est. completion date: October 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Written informed consent before the enrollment

2. Age =18 years old

3. Histologically/cytologically confirmed recurrent or metastatic gastric or esophagogastric junctional adenocarcinoma

4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2

5. Patients able to swallow food and drugs

6. At least one measurable or evaluable lesion according to RECIST criteria version 1.1

7. Adequate bone, hepatic, and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to first administration of study drugs

• Absolute neutrophil count (ANC) = 1,500/ uL, platelet = 100,000/ uL, haemoglobin (Hb) = 9.0 g/dl,

• Serum creatinine = 1.5 mg/dL (If serum creatinine is greater than 1.5 mg/dL, creatinine clearance [Ccr] should be 60 mL/min or greater. Ccr is calculated by Cockcroft-Gault formula or 24hr urine collection)

• Total bilirubin = 1.5 x upper limit of normal (ULN), AST/ALT levels = 3.0 x ULN (AST/ALT levels = 5.0 x ULN for patients with liver involvement of their cancer)

8. In patients who received adjuvant or neoadjuvant chemotherapy, completion of systemic chemotherapy 6 months before the study enrollment, and no previous administration of platinum derivatives

9. Estimated life expectancy of more than 3 months

Exclusion Criteria:

1. Other histologic types than adenocarcinoma

2. Recurrence within 24 weeks following completion of adjuvant chemotherapy

3. R1 gastrectomy (i.e., microscopic residual disease)

4. History of another malignancy within the last five years from the day of written informed consent except cured basal cell carcinoma of skin and cured carcinoma in situ of uterine cervix

5. Radiotherapy within 4 weeks after randomization

6. History of significant neurologic or psychiatric disorders, and presence or history of CNS metastasis

7. Major surgery within 4 weeks before study entry, or insufficient recovery from major surgery (except the patients who received only open and closure or biopsy)

8. Other serious illness or medical conditions as follows;

• Any following conditions occurred within 6 months before study entry: myocardial infarction, severe/unstable angina, bypass surgery for coronary artery/peripheral artery, congestive heart failure (NYHA class III or IV), cerebral infarction or transient ischemic attack

• Conduction abnormality such as 2nd degree or greater AV block or severe arrhythmia that requires medical treatments (right bundle branch block (RBBB) is eligible, but left bundle branch block (LBBB) is not.)

• Uncontrolled hypertension

• Liver cirrhosis (Child Pugh Class B or greater)

• Interstitial pneumonia, pulmonary fibrosis

• Active viral hepatitis B

• Uncontrolled diabetes mellitus

• Uncontrolled ascites or pleural effusion

• Uncontrolled active infection or sepsis

9. Administration of medications which may have potentially pharmacokinetic interaction with S-1, cisplatin, and oxaliplatin

• Flucytosine, a fluorinated pyrimidine antifungal agent

• Anti-viral agents, such as sorivudine, and brivudine, or chemical similar drugs

• Warfarin (except, low dose warfarin for the purpose of prophylaxis), phenprocoumon

• Phenytoin

• Allopurinol

10. Participation to other clinical trials or administration of other investigational drugs within 30 days before the randomisation

11. Pregnant or lactating women

12. Women or men of child bearing potential not employing adequate contraception during study treatments or until the 3 months after the end of study treatments

13. Ineligible for the study at the discretion of investigators

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• S-1
S-1 : 40 mg/m2, twice daily, Day 1-14
• Cisplatin
60 mg/m2/day Day 1
• Oxaliplatin
130 mg/m2/day Day 1

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Bundang-gu, Seongnam-si	Gyeonggi-do
Korea, Republic of	Dongnam Institute of Radiological and Medical Sciences	Busan
Korea, Republic of	Chungbuk National University Hospital	Cheongju-si	Chungcheongbuk-do
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Gangneung Asan Hospital	Gangneung-si
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun-eup, Hwasun-gun	Jeollanam-do
Korea, Republic of	National Cancer Center	Ilsan	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Seoul St. Mary's hospital of the Catholic University of Korea	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Min-Hee Ryu

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (43)

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* Note: There are 43 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	The primary endpoint of this study is progression-free survival. This is defined as the time from randomization to disease progression or death due to any cause.	From date of randomization to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years	No
Secondary	Overall survival	Overall survival is defined as the time from randomization to death due to any cause.	From date of randomization to death from any cause, assessed up to 3 years	No
Secondary	Response rate	Response assessment will be performed according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 every 2 cycles (6 weeks) of treatment.	Every 6 weeks	No
Secondary	Quality of life	Quality of life of patient will be evaluated using EUROQOL(EQ-5D). Evaluation of quality of life will be performed every 2 cycles (6 weeks) from baseline to the end of treatment.	Every 6 weeks	No
Secondary	Number of Adverse Events	Monitoring for safety and toxicity will be performed every cycle (3 weeks) of chemotherapy and whenever patients have problems.	Every 3 weeks	Yes