Locally advanced, resectable stage II/III rectal cancer.
Conditions
Interventions
Trade Name: Erbitux
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: CETUXIMAB
CAS Number: 205923564
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: not less then
Sponsors
Institute of Oncology Ljubljana
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age 18 to 80 if judged fit for surgery. - WHO peformance status 0-1. - Histologically proven rectal adenocarcinoma located below the peritoneum. - T3-T4 or/and nodal involvement determined by rectal ultrasound or computed tomography (CT) or MRI. - No distant metastases. - Adequate haematological, cardiac, liver and renal function. - Signed infomed consent. - Appropriate measures for contraception for men and women, if applicable. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Prior radio- and/or chemotherapy. - Others synchronous cancers. - History of other malignant disease. - Significant heart disease. - Known hypersensitivity to biological drugs. - Pregnant or lactating patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The pathological complete response rate.;Secondary Objective: - The rate of sphincter sparing surgical procedure (according to estimated APR before neoadjuvant treatment). - Toxicity and safety.;Primary end point(s): Pathological complete response rate. | — |
Countries
Slovenia
Outcome results
None listed