Phase II study of Cetuximab with mFOLFOX6 treatment in patients with previously untreated Rectal cancer

Phase II study of Cetuximab with mFOLFOX6 treatment in patients with previously untreated Rectal cancer - Phase II study of Cetuximab with mFOLFOX6 treatment in patients with previously untreated Rectal cancer (CR study in SHIGA)

Status

Recruiting

Phases

Phase 2

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000010791

Enrollment

Registered

2013-05-23

Start date

2013-05-29

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

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Histologically confirmed colorectal cancer (2) Previously receive no chemotherapy for rectal cancer (3) KRAS wild-type (4) age 20-80 years patients (5) ECOG performance status 0 or 1 (6) Patients with confirmed target lesion (7) Patients have enough organ function for study treatment WBC 3,000/mm3-12,000/mm3 Neutrophils>=1,500/mm3 Platelets>=100,000/mm3 Hemoglobin>=9.0g/dL Total bilirubin<=1.5mg/dL AST and ALT<=100 IU/L Creatinine<=1.2mg/dL Creatinine Clearance>=60mL/min (8) Life expectancy of more than 3months (9) Written informed consent from patients themselves

Exclusion criteria

Exclusion criteria: (1) History of serious drug hypersensitivity (2) Women who are pregnant,or wish to become pregnant or men who expect babies (3) Severe infectious disease (38degrees or higher) (4) Serious complications (5) Remarkably abnormal ECG,Clinically significant heart disease (6) Gastrointestinal ulceration or bleeding (7) Serious watery diarrhea (8) Uncontrolable pleural effusion or ascites requiring treatment (9) Cases with brain metastases or cases to doubt metastasis to brain from clinical manifestations (10) Current or previous (within the last 6months) history of GI perforation (11) Previous history of thrombosis,cerebra infarction,pulmonary infarction,hemoptysis (more than 2.5ml) and interstitial pneumonia (12) Cases were operated within 28days before entry (Except for inserting central venous catheters and reservoir) (13) Evidence of congenital bleeding diathesis or coagulopathy (14) Ongoing treatment with anticoagulant (15) Cases have active double cancer (disease free period is within five years) (16) Continuous systemic administration of corticosteroids (17) Patients judged inapproprite for this study by physicians

Design outcomes

Primary

Measure	Time frame
Response Rate	—

Secondary

Measure	Time frame
Adverse effect (AE) Progression free survival (PFS) Disease control rate (DCR) R0 resection rate Rate of surgery Time to Surgery (TTS)	—

Countries

Japan

Contacts

Public ContactEIJI Mekata

Shiga University of Medical Science Department of surgery

hqchemo@belle.shiga-med.ac.jp077-548-2238

Outcome results