A Phase III Study of Docetaxel/S-1 versus S-1 in the Treatment of Curatively Resected Stage III Gastric Cancer

JRCT ID: jRCTs041180146

Registered date:29/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Gastric Cancer
• Date of first enrollment: 02/04/2013
• Target sample size: 1100
• Study type: Interventional

Intervention(s)

Group A (S-1 plus Docetaxel):
1st Course (S-1 alone): S-1 80mg/m2 d1-14, q3w
2nd to 7th Course (S-1 plus docetaxel):Docetaxel: 40 mg/m2 on Day 1 of each cycle
After 7th Course, S-1 alone (80mg/m2 d1-28, q6w) continued until 1 year.
Group B (S-1 Alone):
S-1 alone (80mg/m2 d1-28, q6w) continued until 1 year.

Outcome(s)

• Primary Outcome: 3-year relapse-free survival

Secondary Outcome

3-year and 5-year overall survival
5-year relapse-free survival
Time to treatment failure
Safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

(1) Patients with a histologically confirmed common type of gastric cancer in pathologic stage IIIA, IIIB, or IIIC
(2) Patients who underwent R0 surgery (i.e., no residual tumor) with D2 lymphadenectomy. However, patients who underwent total gastrectomy without splenectomy (without No. 10 lymph node dissection) will also be eligible.
(3) Patients without any hepatic, peritoneal, or distant metastasis, with negative peritoneal lavage cytology
(4) Patients aged between >=20 years and <=80 years at the time of enrollment
(5) Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score 0 or 1
(6) Patients who underwent surgery for the primary disease within the past 6 weeks (i.e., within 42 postoperative days, with the day of surgery defined as postoperative day 0) and who can take oral medication
(7) Patients without any prior nonsurgical therapy (such as radiotherapy or chemotherapy) for the primary disease
(8) Patients with adequately maintained major organ functions meeting the following criteria based on laboratory tests within 14 days before enrollment
(9) Patients who personally provided written consent to participate in the study

Exclude criteria

(1) Patients with synchronous or metachronous multiple primary cancers
(2) Patients with serious postoperative complications (e.g., serious postoperative infection, anastomotic leakage, gastrointestinal hemorrhage)
(3) Patients with serious concurrent diseases (e.g., intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, uncontrolled hypertension, cardiac failure, renal failure, hepatic cirrhosis, hepatic failure)
(4) Patients with active infection
(5) Patients positive for HBs antigen or HCV antibody
(6) Patients receiving chronic systemic (oral or intravenous) steroid therapy
(7) Patients with diarrhea (watery stools)
(8) Patients with serious drug allergy
(9) Patients in whom both iodinated agents and gadolinium-based agents cannot be used because of drug allergy
(10) Patients on oral flucytosine
(11) Patients requiring oral warfarin potassium
(12) Pregnant women or women with possible pregnancy, or men who desire pregnancy of their partner
(13) Other patients judged by the investigator or subinvestigator to be inappropriate for participation in this this study

Related Information

• Primary Sponsor: KODERA Yasuhiro
• Source(s) of Monetary Support: Japan Clinical Cancer Research Organization
• Secondary ID(s): UMIN000010337