North Japan multicenter phase II study of oxaliplatin-containing regimen as adjuvant chemotherapy for stage III colon cancer(NORTH/HGCSG1003 study)

North Japan multicenter phase II study of oxaliplatin-containing regimen as adjuvant chemotherapy for stage III colon cancer(NORTH/HGCSG1003 study) - North Japan multicenter phase II study of oxaliplatin-containing regimen as adjuvant chemotherapy for stage III colon cancer(NORTH/HGCSG1003 study)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004590

Enrollment

270

Registered

2011-01-15

Start date

2010-09-01

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

Oxaliplatin 85mg/m2 day1 Fluorouracil bolus infusion 400mg/m2 day1&amp

2 Fluorouracil continuous infusion 600mg/m2 day1&amp

2(22 hours) Levofolinate 100mg/m2 day1&amp

2 Or Oxaliplatin 85mg/m2 day1 Fluorouracil bolus infusion 400mg/m2 day1 Fluorouracil continuous infusion 2, 400mg/m2 day1(46 hours) Levofolinate 200mg/m2 day1 Treatment is repeated 12 courses ev

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histologically confirmed colon cancer(included rectosigmoid cancer). 2)Histologically proven stage III(any T N1-2 M0) colon cancer. Patients had to have undergo complete resection of primary tumor without gross or microscopic evidence of residual disease. 3)The chemotherapy in this study in order to start treatment within 8 weeks after surgery. 4)Age of 20 years or older 5)Eastern Cooperative Oncology Group(ECOG) performance-status of 0-2. 6)Carcino-embryogenic antigen(CEA) < 10 ng/mL 7)No previous chemotherapy(included adjuvant chemotherapy), immunotherapy or radiotherapy. 8)Needs adequate organ function(bone-marrow, liver renal function) i)absolute neutrophil count > 1,500/microL ii)plateles >= 100,000/microL iii)serum creatinine <= 1.5mg/dL iv)total bilirubine, AST, ALT < 2 times the upper limit of the normal range 9)Written informed consent obtained prior to study entry

Exclusion criteria

Exclusion criteria: 1)Multiple cancer patient 2)Patients who had other cancer within 5 years. 3)Pregnant or lactating women. 4)Patients who had colorectal cancer excluded mucosal cancer. 5)Peripheral sensory neuropathy or Paresthesia(CTCAE v4.0 >= Grade 1). 6)Uncontrolled congestive heart failure or angina pectoris, or hypertension or arrhythmia. 7)History of significant neurologic or psychiatric disorders. 8)Active infection.

Design outcomes

Primary

Measure	Time frame
three-year disease-free survival rate	—

Secondary

Measure	Time frame
1)overall survival 2)relative dose intensity 3)adverse event	—

Countries

Japan

Contacts

Public ContactNaoki Nishimoto

Hokkaido Organization for Translational Research(HTR) Department of Clinical Trial Management

nishimot@med.hokudai.ac.jp011-706-7478

Outcome results

None listed

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