JCOG1503C: Efficacy of aspirin for stage III colorectal cancer: a randomized double-blind placebo-controlled trial

JRCT ID: jRCTs031180009

Registered date:17/01/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: colorectal cancer
• Date of first enrollment: 12/04/2018
• Target sample size: 880
• Study type: Interventional

Intervention(s)

A: Placebo. Patients in this group receive placebo for 3 years with adjuvant chemotherapy(mFOLFOX6, CAPOX ,or capecitabine).
B: Aspirin. Patients in this group receive aspirin, at a dose of 100 mg for 3 years with adjuvant chemotherapy(mFOLFOX6, CAPOX ,or capecitabine).

Outcome(s)

• Primary Outcome: Disease-free survival
• Secondary Outcome: Overall survival, Relapse-free survival, Relative dose intensity, Adverse events, Sever adverse events.

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 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 (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) No anti-platelet drug or anti-coagulant drug at registration.
11) No periodic oral NSAIDs at registration.
12) No history or complication of gastric or duodenal ulcer
13) No history of bronchial asthma.
14) No inflammatory bowel disease and hemorrhagic disease.
15) It is possible to take foods and drugs orally.
16) Within 8 weeks after surgery.
17) Major organ function is preserved. ANC>=3,000/mcl, PLT>=75,000/mcl, T-bil<=2.0 mg/dl, GOT<=100 IU/L, GPT<=100 IU/L , Cr<=1.5 mg/dl
18) The following chemotherapy will be performed as adjuvant chemotherapy.
1.Cpecitabine, 2.mFOLFOX6, 3.CAPOX
19) 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) History of allergy aspirin or salicylic acid.
5) Female during pregnancy, within 28 days of postparturition, or during lactation.
6) Severe psychological disease.
7) Continuous systemic corticosteroid or immunosuppressant treatment.
8) Severe postoperative complicatoins which do not resolve until registration.
9) Regularly using phenytoin.
10) Uncontrollable diabetes mellitus.
11) Uncontrollable hypertension.
12) Unstable angina pectoris, or history of myocardial infarction within 6 months. "

Related Information

• Primary Sponsor: TAKASHIMA Atsuo
• Source(s) of Monetary Support: National Cancer Center Japan,Japan Agency for Medical Research and Development
• Secondary ID(s): UMIN000031532