Randomized phase III trial comparing adjuvant S-1 to capecitabine in stage III colorectal cancer (JCOG0910, CRC Adj-CAPS)

Conditions

Stage III colorectal cancer

Hamaguchi T, Shimada Y, Mizusawa J, Kinugasa Y, Kanemitsu Y, Ohue M, Fujii S, Takiguchi N, Yatsuoka T, Takii Y, Ojima H, Masuko H, Kubo Y, Mishima H, Yamaguchi T, Bando H, Sato T, Kato T, Nakamura K, Fukuda H, Moriya Y.

2017-10-2445 citations

10.1016/s2468-1253(17)30297-2

Predictive factor for toxicities and treatment termination in adjuvant S-1 therapy for stage III colorectal cancer using data from JCOG0910.

Kentaro Yamazaki, Yukio Yoshida, Junki Mizusawa, Yukihide Kanemitsu, Yusuke Kinugasa et al. (20 authors)

Journal of Clinical Oncology2016-02-01

10.1200/jco.2016.34.4_suppl.669

Randomized phase III study of adjuvant chemotherapy with S-1 versus capecitabine (cape) in patients with stage III colon cancer (CC): Results of Japan Clinical Oncology Group study (JCOG0910).

Tetsuya Hamaguchi, Yasuhiro Shimada, Junki Mizusawa, Yusuke Kinugasa, Yukihide Kanemitsu et al. (21 authors)

Journal of Clinical Oncology2015-05-204 citations

10.1200/jco.2015.33.15_suppl.3512

S-1 as adjuvant chemotherapy for stage III colon cancer: a randomized phase III study (ACTS-CC trial).

Yoshida M, Ishiguro M, Ikejiri K, Mochizuki I, Nakamoto Y, Kinugasa Y, Takagane A, Endo T, Shinozaki H, Takii Y, Mochizuki H, Kotake K, Kameoka S, Takahashi K, Watanabe T, Watanabe M, Boku N, Tomita N, Nakatani E, Sugihara K, ACTS-CC study group.

2014-06-1879 citations

10.1093/annonc/mdu232

Interventions

A: capecitabine. Patients in this group receive 8 courses of oral capecitabine, at a dose of 1,250 mg/m2 twice daily for 14 days every 21 days. B: S-1. Patients in this group receive 4 courses of oral

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Pathologically proven colorectal adenocarcinoma. 2) Tumor is mainly located in between cecum and upper rectum, excluding appendix and that invades to lower rectum. 3) Tumor resection with D2 or D3 lymph node dissection was performed. 4) R0 resection was performed. 5) Stage III cancer by General Rules for Clinical and Pathological Studies on Cancer of the Colon, Rectum and Anus (same as UICC TNM classification 7th ed.). 6) No synchronous colorectal cancer which invade muscularis propria or deeper. 7) Age at registration is of 20 to 80 years old. 8) ECOG Performance status is 0 or 1. 9) No prior chemotherapy or radiation therapy. 10) It is possible to take foods and drugs orally. 11) Within 8 weeks after surgery. 12) Major organ function is preserved.WBC>=3,000/mcl, PLT>=75,000/mcl, GOT<=100 IU/L, GPT<=100 IU/L , Cr<=1.5 mg/dl 13) Witten informed consent is taken

Exclusion criteria

Exclusion criteria: 1) Body temperature is higher than 38 degrees centigrade at registration. 2) Infections which needs systemic treatment. 3) Active co-existing malignancy (synchronous or metachronous malignancy whose disease-free period is within 5 years). Carcinoma in situ is eligible. 4) Severe postoperative complicatoins which do not resolve until registration. 5) Regularly using phenytoin or warfarin potassium. 6) Pregnant or breast-feeding woman. 7) Difficult to participate in the trial due to mentel disorder or psychiatric symptoms. 8) Systemic steroids medication. 9) Uncontrollable diabetes mellitus. 10) Uncontrollable hypertension. 11) History of severe heart disease, heart failure, myocardial infarction within the past 6 months or attack of angina pectoris within the past 6 months.

Design outcomes

Primary

Measure	Time frame
Disease-free survival	—

Secondary

Measure	Time frame
Overall survival, Relapse-free survival, Adverse events (including treatment related death, early death, grade 4 non-hematological toxicities, grade 2 or more Hand-foot skin reaction).	—

Countries

Japan

Contacts

Public ContactTetuya Hamaguchi

JCOG0910 Coordinating Office Division of medical oncology, National Cancer Center Hospital

JCOG_sir@ml.jcog.jp03-3542-2511

Outcome results

None listed