JCOG1507: A phase III trial to confirm S-1 adjuvant chemotherapy for pathological stage II/III vulnerable elderly gastric cancer patients

JRCT ID: jRCTs031180255

Registered date:13/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Gastric neoplasm
• Date of first enrollment: 23/01/2017
• Target sample size: 170
• Study type: Interventional

Intervention(s)

Arm A: treatment free

Arm B: Patients receive S-1 orally twice a day for 4 weeks administration/2-week discontinuation. The initial dose of S-1 is reduced by >1 level versus the standard dose according to Ccr and type of surgery and is administered for 1 year after surgery.

Outcome(s)

• Primary Outcome: Overall survival
• Secondary Outcome: Relapse-free survival, time-to-treatment-failure, proportion of treatment continuation, relative dose intensity, adverse events, severe adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 80age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Histologically proven gastric adenocarcinoma
2) Pathological stage II/III defined by 14th edition of Japanese Classification of Gastric Carcinoma
3) Received R0 gastrectomy with D1+ or D2 lymphadenectomy
4) Either of the following surgery performed;
i) Open laparotomy regardless of clinical stage and type of gastrectomy
ii) Laparoscopic or laparoscope-assisted gastrectomy regardless of clinical stage and type of gastrectomy
5) Either of the followings:
i) Weight loss < 15% and 30 mL/min <= Ccr for the patients received total gastrectomy
ii) Weight loss < 15% and 30 mL/min <= Ccr < 80 mL/min for the patients not received total gastrectomy
6) Within 5 to 12 weeks after surgery
7) Aged 80 years old or older
8) Performance status of 0 or 1
9) No gastric stump cancer
10) No previous treatment of chemotherapy, radiation therapy, or molecular-target therapy for any neoplasms. (History of hormone therapy more than one year ago is eligible.)
11) Enough oral intake
12) No dementia, or dementia with family support to continue protocol treatment or examinations
13) Sufficient organ functions
14) No ischemic change on ECG
15) Written informed consent

Exclude criteria

1) Synchronous double/multiple cancer or metachronous double/multiple cancer with progression free period of 5 years or shorter
2) Infectious disease requiring systemic treatment
3) Body temperature of 38 degrees Celsius or higher
4) Severe mental disease
5) Requiring systemic steroid medication (>= 5 mg/day of prednisolone)
6) Under treatment by flucytosine, phenytoin, or warfarin potassium
7) Uncontrolled diabetes mellitus
8) Uncontrolled hypertension
9) Unstable angina pectoris (angina developed or attack worsened within recent 3 weeks) or previous myocardial infarction within 6 months
10) Positive for HBs antigen
11) Severe interstitial pneumonia, severe lung fibrosis, or severe emphysema
12) Surgical morbidity such as infection, leakage, intestinal bleeding, pancreatic fistula, and so on is not improved

Related Information

• Primary Sponsor: YOSHIDA Kazuhiro
• Source(s) of Monetary Support: National Cancer Center Japan,Japan Agency for Medical Research and Development
• Secondary ID(s): UMIN000025742