Phase II study of FOLFOX4 in patients with advanced/recurrent colorectal cancer previously treated with 5FU (OGSG 0503)

Phase II study of FOLFOX4 in patients with advanced/recurrent colorectal cancer previously treated with 5FU (OGSG 0503) - OGSG0503

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000734

Enrollment

Registered

2007-06-15

Start date

2005-04-01

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

advanced/recurrent colorectal cancer

Interventions

FOLFOX 4 Treatment Day 1: 1. L-OHP 85mg/m2 is mixed with 250 cc of 5% glucose infusion.(A) 2. l-LV 100 mg/m2 is mixed with 250 cc of 5% glucose infusion.(B) 3. A and B are drip-infused by 2 hours

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Eligibility criteria (1) colorectal cancer, histologically (2) advanced or recurrent colorectal cancer (3) colorectal cancers previously treated with 5FU which satisfy the following factors * more than 4 weeks after the end of prior chemotherapy ( more than two weeks if patients have progressive lesions) &#61548;without previous L-OHP therapy &#61548;When patients have been undergone chemotherapy, some signs of progression of tumor &#61548;were found in CT or tumor markers within 26 weeks. (4) with measurable lesions (5) age: older than 20 years and younger than 75years (6) Performance Status: 0-2 in ECOG criteria (7) Longer than 12 weeks of expected survival (8) sufficient function in the important organs WBC 4,000<= and =< 12,000 mm3/dl Platelet 100,000/mm3 <= Total bilirubin within 1.5 times of normal range of each institute AST, ALT within 2.5 times of normal range in each institute Serum creatinin within normal range of each institute ECG normal range 10) written informed consents

Exclusion criteria

Exclusion criteria: Excluding Criteria 1. cavity fluid which should be taken out 2. with double cancer and/or multiple cancer which excludes carcinoma in situ 3. with peripheral nerve disorder 4. with infectious disease 5. under the condition of diarrhea (watery diarrhea) 6. with psychological disorder which disturb the entry to the study 7. under continuous steroids therapy 8. with other severe diseases(pulmonary fibrosis, cardiac failure, liver dysfunction, renal dysfunction, intestinal paralysis/obstruction or uncontrolled DM) 9. pregnant and/or nursing women 10. with allergic history against medicines 11. doctors' stop not to register to the study

Design outcomes

Primary

Measure	Time frame
Response Rate	—

Secondary

Measure	Time frame
Incidence of Adverse Events,Feasibility,Survival Time, Relative Dose Intensity	—

Countries

Japan

Contacts

Public ContactFurukawa Hiroshi

Sakai City Hospital Director

072-221-1700

Outcome results

None listed

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