Phase II study of adjuvant chemotherapy of OPTIMOX therapy (intermittent FOLFOX regimen) for Stage III colon cancer (including Rectosigmoid cancer).

Phase II study of adjuvant chemotherapy of OPTIMOX therapy (intermittent FOLFOX regimen) for Stage III colon cancer (including Rectosigmoid cancer). - Triple 4 study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003672

Enrollment

Registered

2010-06-01

Start date

2010-02-01

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 (including Rectosigmoid cancer)

Interventions

Adjuvant chemotherapy Oxaliplatin 85mg/m2/bi-week(day1) l-LV 200 mg/m2/bi-week(day1) 5-FU/bolus 400mg/m2/bi-week bolus(day1) 5-FU/infusional 2400mg/m2/bi-week(day1-3)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically confirmed Colorectal adenocarcinoma and histological Stage III Colon cancer (including Rectosigmoid cancer). 2.Curative resection with D2 or more extensive lymph node dissection. 3.Resection of histological curability A was performed. 4.Age: 20-80 years old. 5.Performance status (ECOG):0-2 6.No prior chemotherapy and radiotherapy and immunotherapy. 7.Adequate organ function. * WBC:3,000/mm3-12,000/mm3 * Neutrophil count <=1500/mm3. * Platelet count<=;100,000/mm3. Liver function tests * AST (GOT) and ALT (GPT)>=;2.5*ULN. * Total bilirubin>=;2.5*ULN. Renal function test * Serum creatinine>=;1.25*ULN. 8.Chemotherapy will be started within 8 weeks from operation. 9.Written informed consent.

Exclusion criteria

Exclusion criteria: 1.Pregnant or nursing 2.Administering antithrobotic drug within 14 days 3.Medical history of allergy or hypersensitivity reactions. 4.Peripheral neuropathy (CTC AE v3.0 <= Grade1) 5.Active infection 6.Serious complications (renal failure or hepatic failure or heart failure) 7.Interstitial pnumonitis, pulmonary fibrosis or high-grade pulmonary emphysema. 8.Treated heart disease within 12 months 9.History of mental disturbances or cerebrovascular attack. 10.Watery diarrhea. 11.History of other colorectal cancer (including; sarcoma, carcinoid, lymphoma etc). 12.History of cancer (disease free interval was less than 10 years) 13.Double cancer. 14.Other conditions not suitable for this study

Design outcomes

Primary

Measure	Time frame
The incidence of oxaliplatin induced neuropathy.	—

Secondary

Measure	Time frame
The incidence of all adverse events (Excluding neuropathy). Disease free survival (DFS) Overall survival (OS)	—

Countries

Japan

Contacts

Public ContactToshinori Ando, Koh Miura

Tohoku University Graduate School of Medicine Division of Biological-regulation and Oncology

022-217-7205

Outcome results

None listed

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