JCOG1805: Randomized controlled study of adjuvant chemotherapy for stage II colorectal cancer patients at high risk of developing recurrence according to T-stage and three selected pathological factors

JRCT ID: jRCTs031190186

Registered date:15/01/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: colorectal cancer
• Date of first enrollment: 30/01/2020
• Target sample size: 1440
• Study type: Interventional

Intervention(s)

A: Observasion (surgely-alone). Patients in this group are observed without any adjuvant chemotherapy.
B: Capecitabine for 6 month: Capecitabine (1,250 mg/m2) is orally administered twice daily after meals for 14 days, followed by a 7-day rest. A total of 8 courses are administered
C: CAPOX for 3 month: Oxaliplatin (130 mg/m2) is administered intravenously at day 1, and capecitabine (1,000 mg/m2) is orally administered twice daily after meals for 14 days, followed by a 7-day rest. A total of 4 courses are administered.

Outcome(s)

• Primary Outcome: Relapse-free survival (RFS)
• Secondary Outcome: Disease-free survival (DFS) / Overall survival (OS) / Adverse events / Incremental cost-effectiveness ratio (ICER)

Key inclusion & exclusion criteria

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

Include criteria

1) Pathologically proven colorectal adenocarcinoma.
2) Tumor is mainly located between cecum and lower rectum.
3) Tumor resection with D2 or D3 lymph node dissection with open or laparoscopic approach was performed, regardless of with or without lateral lymph node dissection (Robotic surgery is allowed for enrollment).
4) R0 resection was performed.
5) pStage II cancer (JSCCR classification 9th ed.).
6) Tumor is associated with at least one following factors;
(a) Depth of tumor: pT4,
(b) Tumor budding: BD3,
(c) Perineural invasion: Pn1,
(d) Desmoplastic reaction (DR) category: intermediate/immature
7) Between 28 to 56 days after surgery.
8) Age at registration is of 20 to 80 years old.
9) ECOG Performance status is 0 or 1.
10) No prior chemotherapy.
11) It is possible to take foods and drugs orally.
12) Major organ function is preserved.
(a) ANC>=1,500/mm3,
(b) PLT>=100,000/mm3,
(c) T-bil<=1.5 mg/dL,
(d) AST<=100 IU/L,
(e) ALT<=100 IU/L,
(f) Cr<=1.5 mg/dL,
(g) Ccr>=50 mL/min,
13) Witten informed consent is obtained

Exclude criteria

1) Synchronous or metachronous (within 5 years) malignancies
2) Infections which needs systemic treatment.
3) Body temperature is higher than 38 degrees centigrade at registration.
4) Female during pregnancy, within 28 days of postparturition, or during lactation. Male who wants partner's pregnancy.
5) Severe psychological disease.
6) Continuous systemic corticosteroid or immunosuppressant treatment.
7) Uncontrollable diabetes mellitus.
8) Uncontrollable hypertension.
9) Unstable angina pectoris, or history of myocardial infarction within 6 months.
10) Uncontrollable valvular heart disease, dilated cardiomyopathy, or
hypertrophic cardiomyopathy.
11) Regularly using phenytoin.
12) Severe postoperative complicatoins which do not resolve until registration.

Related Information

• Primary Sponsor: Ueno Hideki
• Source(s) of Monetary Support: National Cancer Center Japan,Japan Agency for Medical Research and Development