eoadjuvant radio-immunochemotherapy withcetuximab and 5-FU for advanced rectal cancer

• Conditions: advanced adenocarcinoma of the rectum; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2005-004139-23-DE
• Lead Sponsor: niversity of Cologne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-30
• Last Update Posted: 16 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Signed written informed consent
• Male or female > 18 years of age
• Histologically proven locally advanced adenocarcinoma of the rectum (T3, T4, any nodal stage) with the
inferior margin of the tumor being no farther than 16 cm from the anal verge
• Surgical resectability or possible sphincter preservation after neoadjuvant treatment
• ECOG Performance Status < 2
• Adequate bone marrow function: leucocytes > 3.0 x 109/L, neutrophils > 1.5 x 109/L, platelets > 100 x 109/L,
hemoglobin > 10.0 g/dL
• Adequate liver function: Bilirubin < 2.0 mg/dL, SGOT, SGPT, AP, gamma-GT < 3 x ULN
• Adequate renal function: serum creatinine < 1.5 mg/dL, creatinine clearance > 50 ml/min (calculated value
according to Cockroft-Gault equation)
• If of childbearing potential, willingness to use effective contraceptive method for an adequate period of time.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Prior pelvic radiotherapy
• Prior chemotherapy
• Presence of distant metastases
• Clinically relevant coronary artery disease or a history of myocardial infarction within the last 12 months or left
ventricular ejection fraction (LVEF) below the institutional range of normal
• Other chronic bowel disease (malabsorption, inflammatory bowel disease, acute or subacute intestinal
occlusion)
• Prior exposure to EGFR pathway targeting therapy
• Having participated in another clinical trial or any investigational agent in the preceding 30 days
• Any active dermatological condition > Grade 1
• Known allergic/hypersensitivity reaction to any of the components of the treatment
• Pregnancy (absence confirmed by serum/urine ?-HCG) or breast-feeding
• Known drug abuse/alcohol abuse
• Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the
skin or pre-invasive carcinoma of the cervix
• Legal incapacity or limited legal capacity
• Medical or psychological condition which in the opinion of the investigator would not permit the patient to
complete the study or sign meaningful informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified