Clinical trial of adjuvant chemotherapy with mFOLFOX6 (L-OHP+l-LV/5-FU)/XELOX(L-OHP+Capecitabine)after curative resection for stage III colon cancer

Clinical trial of adjuvant chemotherapy with mFOLFOX6 (L-OHP+l-LV/5-FU)/XELOX(L-OHP+Capecitabine)after curative resection for stage III colon cancer - FACOS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005427

Enrollment

130

Registered

2011-04-12

Start date

2010-04-01

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

mFOLFOX6(L-OHP:85mg/m2, l-LV:200mg/m2, 5FU:400mg/m2 (bolus), 5FU:2,400mg/m2 (civ)). Cycles of chemotherapy are given every 2 weeks for 6 months. XELOX(Capecitabine:2000mg/m2,Oxaliplatin:130mg/m2).

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Stage III colon and rectosigmoid cancer. 2.Colectomy with D2<= Lymph node dissection. 3.Resection of histological curability A was performed. 4.20-75 years old. 5.Performance Status(ECOG):0 or 1 6.Without prior anti-tumor therapy (chemotherapy and radiotherapy). 7.Adequate functions of bone marrow, liver and renal as belowes: WBC>= 4,000/mm3 to =<12,000mm3. Neutrophil >= 2,000/m m3. Platlet is >= 100,000/m m3. Hemoglobin >= 9.0g/dL. AST and ALT =< 100IU/L. Creatinine is within normal limits. 8.Able to start therapy between 4 and 8 weeks after surgery. 9.Written Informed Consent.

Exclusion criteria

Exclusion criteria: 1.Synchronous multiple cancer and metachronous multiple cancer within 5-years. 2.Severe postoperative complications ,such as infection, ruptured suture, gastrointestinal bleeding. 3.Sensory peripheral neuropathy. 4.Uncontrolled hypertension. 5.Uncontrolled Diabetes Mellitus. 6.Marked abnormality of ECG, or clinically important cardiac disorders such as congestive heart failure, symptomatic coronary artery disease, uncontrolled arrythmia,history of cardiac infarction within 12 months. 7.Severe pulmonary complications, such as interstitial pneumonitis, pulmonary fibrosis, pulmonary emphysema. 8.With Evidence or history of psychiatric disability and central neurological disorder. 9.Diarrhea. 10.Systemic continuous administration of steroid drugs(p.o. or i.v.). 11.Pregnant, woman of child-bearing potential or lactating woman. 12.Not appropriate for the study at the physician's assessment.

Design outcomes

Primary

Measure	Time frame
3-year disease-free survival	—

Secondary

Measure	Time frame
Safety 2-year disease-free survival 5-year median survival	—

Countries

Japan

Contacts

Public ContactSatomi Oyama

Saitama Medical Center,Saitama Medical University Department of digestive tract and

05hishi@saitama-med.ac.jp048-228-3619

Outcome results

None listed

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