Trial of 3-weekly Versus 5-weekly Schedule of S-1 Plus Cisplatin in Gastric Cancer: SOS

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The urgent need for a new effective therapy with better safety profile for the metastatic gastric cancer patients and promising results observed so far in the studies with S-1 plus cisplatin combination in advanced gastric cancer (AGC) strongly warrants the comparison of a 3-weekly schedule to a 5-weekly schedule of S-1 plus cisplatin as a standard regimen in the first-line treatment for AGC patients.

The objectives of this study are to compare a 3-weekly schedule to a 5-weekly schedule of S-1 plus Cisplatin combination in terms of efficacy, quality of life and safety in patients with previously untreated advanced or recurrent unresectable gastric cancer. Primary endpoint is progression-free survival. This is an open label, randomized, multi-center, non-inferiority/superiority (of 3-weekly regimen over 3-weekly regimen) hybrid study.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Collaborators: Chonbuk National University Hospital; Chonnam National University Hospital; Gachon University Gil Medical Center; Hallym University Medical Center; Inje University; Korea Cancer Center Hospital; Kyungpook National University; Kyungpook National University Hospital; National Cancer Center, Korea; Samsung Medical Center; Seoul Veterans Hospital; Ulsan University Hospital; Yeungnam University College of Medicine
• Treatments: Cisplatin

Criteria

Inclusion Criteria:

• Histologically documented metastatic or recurrent gastric adenocarcinoma including adenocarcinoma of the gastro-esophageal junction

• Age 18 to 74 years old

• Performance status (ECOG scale) 0-2

• No significant problems for oral intake and drug administration

• At least one measurable or evaluable disease defined by RECIST

• Adequate bone marrow function (ANC ≥ 1,500/uL, Platelet ≥ 100,000/ uL, Hb ≥ 9.0 g/dl)

• Adequate renal function: serum creatinine ≤ UNL (if serum creatinine > UNL, creatinine clearance should be ≥ 60 mL/min)

• Adequate hepatic function (Total bilirubin < 2 x UNL and AST/ALT levels < 3 x UNL without liver metastasis,total bilirubin < 3x ULN and AST/ALT levels < 5 x UNL with liver metastasis)

• Prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive immunotherapy) is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study) and cisplatin was not used before

• Patients should sign a written informed consent before study entry

Exclusion Criteria:

• Tumor type other than adenocarcinoma

• Previously exposed to any fluropymidine within 6 months before the study

• Previously exposed to Platinum therapy regardless of its period and/or duration

• Microscopic residual disease only after noncurative gastrectomy with R1 resection (resection margin positive)

• Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence)

• Prior radiotherapy was administered to target lesions selected for this study, or radiotherapy to the non-target lesions has been completed within 4 weeks before randomization

• Presence of CNS metastasis

• Major surgery within 4 weeks before initiation of study treatment or lack of complete recovery from the effects of major surgery (patient received curative operation or RFA for metastatic disease)

• Serious illness or medical conditions:

• Congestive heart failure (NYHA class III or IV)

• Unstable angina or myocardial infarction within the past 12 months

• Significant arrhythmias requiring medication and conduction abnormality such as over 2nd degree AV block

• Uncontrolled hypertension

• Hepatic cirrhosis (≥ Child class B)

• Interstitial pneumonia

• Pulmonary adenomatosis

• Psychiatric disorder that may interfere with protocol compliance

• Unstable diabetes mellitus

• Uncontrolled ascites or pleural effusion

• Active infection

• Receiving a concomitant treatment interacting with S-1 or cisplatin:

• Flucytosine (a fluorinated pyrimidine antifungal agent)

• Antivirals such as sorivudine, ramivudine, brivudine or other chemically related agents, warfarin, phenprocoumon, phenytoin, allopurinol

• Pregnant or lactating woman

• Women of child bearing potential not using a contraceptive method

• Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential

• Any patients judged by the investigator to be unfit to participate in the study