A feasibility study of neoadjuvant chemotherapy with mFOLFOX6 in patients with locally metastatic rectal cancer

A feasibility study of neoadjuvant chemotherapy with mFOLFOX6 in patients with locally metastatic rectal cancer - A feasibility study of neoadjuvant chemotherapy with mFOLFOX6 in patients with locally metastatic rectal cancer

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003428

Enrollment

Registered

2010-04-01

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

rectal cancer

Interventions

Neoadjuvant chemotherapy with mFOLFOX6(4-6cycle) followed by surgery

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically confirmed Rectum adenocarcinoma 2.No prior anti-tumor therapy without surgery 3.More than 4 weeks interval after surgery 4.Synchronous or metachronous liver metastases(H2,H3) 5. Performance status 0-2 6. age:20-75years old 7. A predicted life expectancy of at least 12 weeks 8. Adequate organ function 9.Written IC

Exclusion criteria

Exclusion criteria: 1.Transfusion, blood products, and G-CSF within 14 days before egistration 2.History of serious drug hypersensitivity or allergy 3.Multiple malignancies 4.Uncontrolled complication of pleural, ascites and pericardium fluid 5.Infection 6 Current or previous brain and bone metastasis 7.Serious heart disease such as congestive heart failure, symptomatic coronary artery disease, uncontrolled arrhythmia 8.Serious hepatic toxicit, pulmonary complaints(interstitial pneumonia) 9.Serious dysesthesia 10.Diarrhea 11.Intestinal paralysis and intestinal obstruction 12.Evidence of psychiatric disability interfering with enrollment to clinical trial 13.Uncontrolled diabetic 14.With atazanavir sulfate. 15.With TS-1 16.Pregnancy 17.Patients judged inappropriate for this study by physicians

Design outcomes

Primary

Measure	Time frame
OS, DFS	—

Secondary

Measure	Time frame
Pathological effect, Down stgaging	—

Countries

Japan

Contacts

Public ContactJunichi Koike

Toho University school of medicine Division of general and gastroenterological surgery, Department of Surgery (Omori)

jkoike18@med.toho-u.ac.jp03-3762-4151

Outcome results

None listed

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