Feasibility study of adjuvant chemotherapy with FOLFOX(or XELOX) for 3 months followed by oral anticancer drug for 3 months in patients with completely resected colorectal cancer

Feasibility study of adjuvant chemotherapy with FOLFOX(or XELOX) for 3 months followed by oral anticancer drug for 3 months in patients with completely resected colorectal cancer - Feasibility study of Sequential chemotherapy with L-OHP-based therapy followed by oral anticancer drug in patients with completely resected colorectal cancer (JSWOG C2 study)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004934

Enrollment

Registered

2011-02-01

Start date

2011-03-01

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

mFOLFOX6 therapy(or XELOX therapy) for 3 months followed by capecitabine for 3 months mFOLFOX6 therapy Day1 L-OHP 85mg/m2,l-LV 200mg/m2 Day1 bolus 5FU 400mg/m2 Day1~2 Infusional 5FU 2400mg/

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)histopathologically confirmed colorectal cancer. 2)StageIII(or high risk stageII) and R0 resection. 3)After resection, it is possible to begin the adjuvant chemotherapy within 8 weeks 4)Age of 20 years or older. 5)ECOG Performance status(PS) of 0-1. 6)No prior treatments with chemotherapy(contain adjuvant chemotherapy), radiation therapy, immune therapy 7)no severe organ failure --White blood cell count >= 3,000/mm3 and <= 12,000/mm3 --Neutrophil count >= 1,500/mm3 --Platelet count >= 100,000/mm3 --AST(GOT) and ALT(GPT) <= 100IU/L --Total bilirubin <= 2.0mg/dL --serum creatinine <= 1.5mg/dL 8)Written informed consent will be obtained from each patient before enrollment.

Exclusion criteria

Exclusion criteria: 1)a history of serious drug hypersensitivity or serious drug allergy. 2)active double cancer 3) women who are pregnant, lactating, or wish to become pregnant 4)a history of colorectal cancer 5)more than grade 1 (CTCAE v4.0) peripheral neuropathy 6)clinically significant heart disease 7) judged to be unsuitable for this trial due to clinically significant mental / psychological disease etc 8)clinically important infection or suspected infection in febrile patients. 9)diarrhea(watery) or diarrhea that interferes with daily activities for patients with a stoma. 10) dementia 11)diabetes with uncontrolled or accompanied neuropathy 12)judged to be ineligible by principal investigator for any other reason.

Design outcomes

Primary

Measure	Time frame
Frequency and Grade of peripheral neuropathy(CTCAE v4 and PNQ)	—

Secondary

Measure	Time frame
1)Proportion of completion in oxaliplatin base therapy 2)Proportion of completion in adjuvant chemotherapy 3)Disease free survival 4)Proportion of treatment selection 5)Adverse event 6)Compare FOLFOX to XELOX in efficacy or adverse event	—

Countries

Japan

Contacts

Public ContactKazuki Yamashita

Okayama Rosai Hospital Surgery

086-262-0131

Outcome results

None listed

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