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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031210365

Enrollment

Registered

2021-10-04

Start date

2021-11-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon cancer

Interventions

A: Neoadjuvant chemotherapy (mFOLFOX6 x 6 cycle) + Surgery + Adjuvant chemotherapy (mFOLFOX6 x 6 cycle) B: Neoadjuvant chemotherapy (FOLFOXIRI x 6 cycle) + Surgery + Adjuvant chemotherapy (mFOLFOX6 x

Eligibility

Sex/Gender

All

Inclusion criteria

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(= 1,500 /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

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.

Design outcomes

Primary

Measure	Time frame
Tumor Regression Score (TRS) 0-2 rate (Central diagnosis of pathology)	—

Secondary

Measure	Time frame
Overall survival, Progression-free survival, Local progression-free survival, Proportion of patients with R0 resection, Response rate of neoadjuvant chemotherapy, Incidence of adverse events, Incidence of severe adverse events, Incidence of surgical adverse events, Proportion of patients without combined resection of other organ, Pathological response rate of neoadjuvant chemotherapy (Japanease Classification of Colorectal, Appendiceal, and Anal Carcinoma, 9th edition), Tumor Regression Score (TRS) 0-2 rate (Facility diagnosis)	—

Measure

Time frame

Overall survival, Progression-free survival, Local progression-free survival, Proportion of patients with R0 resection, Response rate of neoadjuvant chemotherapy, Incidence of adverse events, Incidence of severe adverse events, Incidence of surgical adverse events, Proportion of patients without combined resection of other organ, Pathological response rate of neoadjuvant chemotherapy (Japanease Classification of Colorectal, Appendiceal, and Anal Carcinoma, 9th edition), Tumor Regression Score (TRS) 0-2 rate (Facility diagnosis)

—

Contacts

Public ContactSatoshi Maruyama

Niigata Cancer Center Hospital

s-maru@niigata-cc.jp+81-25-266-5111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026