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
- Conditions
- colorectal cancer
- Registration Number
- JPRN-jRCTs031190186
- Lead Sponsor
- eno Hideki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1440
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relapse-free survival (RFS)
- Secondary Outcome Measures
Name Time Method Disease-free survival (DFS) / Overall survival (OS) / Adverse events / Incremental cost-effectiveness ratio (ICER)