JCOG2006: A randomized phase II study comparing preoperative adjuvant chemotherapy with mFOLFOX6 versus FOLFOXIRI for resectable locally advanced colon cancer

Phase 2

Recruiting

• Conditions: Colon cancer

• Registration Number: JPRN-jRCTs031210365
• Lead Sponsor: TAKII Yasumasa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-04
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

(1) Pathologically proven colorectal adenocarcinoma with endoscopic biopsy specimen.
(2) Tumor is mainly located between cecum and rectal sigmoid colon.
(3) Diagnosed on contrast-enhanced abdominal/pelvic CT(<=1.25mm) either (a) or (b)
(a) cT4b and cN+
(b) cT3-T4a and cN2-3
(4) No distant metastasis on chest CT and contrast-enhanced abdominal/pelvic CT (cM0).
(5) Age, 18 - 75 years old.
(6) ECOG Performance status, 0 or 1.
(7) No prior chemotherapy.
(8) No multiple colorectal cancer diagnosed on colonscopy and imaging test.
(9) UGT1A1 genotypes that do not include *6/*6, *28/*28, or *6/*28.
(10) Sufficient organ function.
(a) Neutrophil count >= 1,500 /mm3
(b) Hemoglobin >= 8.0 mg/dL
(c) Platelet count >= 100,000 /mm3
(d) AST =< 100 U/L
(e) ALT =< 100 U/L
(f) Total Bilirubin =< 2.0 mg/dL
(g) Cr =< 1.5 mg/dL
(11) Without ileus or bowel perforation.
(12) Written informed consent is obtained.

Exclusion 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) Interstitial pneumonia, pulmonary fibrosis, severe emphysema diagnosed on chest CT.

Study & Design

• Study Type: Interventional
• Study Design: Not specified