Preventive Effect of Goshajinkigan on Peripheral Neurotoxicity of FOLFOX Therapy :A Placebo-controlled Double-blind Randomized Phase III Study

Preventive Effect of Goshajinkigan on Peripheral Neurotoxicity of FOLFOX Therapy :A Placebo-controlled Double-blind Randomized Phase III Study - Goshajinkigan Effect for oxaliplatin Neurotoxicity Inhibition USing mFOLFOX6 regimen(GENIUS)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004282

Enrollment

310

Registered

2010-10-01

Start date

2010-10-01

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

Colorectal cancer

Interventions

Goshajinkigan 7.5g/day, 12 course + mFOLFOX6 12 course Placebo 7.5g/day, 12 course + mFOLFOX6 12 course

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Written informed consent 2)Patients who is judged by investigator to be able to receive the protocol therapy 3)Patients with histologically proven colorectal cancer and lower edge of tumor located upper than Douglas pouch 4)p-Stage IIIa /IIIb 5)R0 (Curability A) 6)Age; 20<=, <=80 7)ECOG performance status 0-1 8)within 8 weeks from operation 9) Patiens have enough organ function based on blood test 1.WBC>=3,000-<=12,000/mm3, 2.Neurtophils>=1,500/mm3 3. Platelets>=100,000/mm3 4. Hemoglobin>=9.0g/dl 5. Total bilirubin<=2.0mg/dl 6.AST<=100U/L 7.ALT<=100U/L 8. Creatinine<=1.5mg/dl

Exclusion criteria

Exclusion criteria: 1)transfusion, G-CSF etc. within 7days 2)severe allergic reaction 3)peripheral neuropthy 4)Simultaneous or metachronous double cancers 5)Active infectious disease 6)Severe mental disease 7)Grade2+, diarrhea 8)systemic administration of corticosteroids 9)Pregnant or lactating women or women of childbearing potential 10)Severe comorbidity (interstitial peumonitis, lung fibrosis, paralytic ileus, mechanical ileus, uncontrollable diabetes, liver cirosis, chronic hepatitis, career with hepatitis B/C, renal failure, heart failure, uncontrollable hypertension, unstable angina etc) 11)AMI within 6 months 12)History of transplantation 13)Preoperative therapy for CRC 14)History of colostomy 15)Unhealing of post-operative complication 16)Gashajinkigan, or drug for neuropathy 17)Any other cases who are regarded as inadequate for study enrollment by the investigator

Design outcomes

Primary

Measure	Time frame
TimeToGrade2+ (CTCAE v4.0) Neuropathy; TTN	—

Secondary

Measure	Time frame
L-OHP dose intensity DI safety	—

Countries

Japan

Contacts

Public ContactSatomi Abe

Graduate School of Medical Sciences, Kyushu University Department of Surgery and Science

abesato@surg2.med.kyushu-u.ac.jp092-642-5466

Outcome results

None listed

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