advanced adenocarcinoma of the rectum
Conditions
Interventions
Trade Name: Erbitux
Product Name: Cetuximab
Product Code: EMD271786
Pharmaceutical Form: Solution for infusion
Sponsors
University of Cologne
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase I part of the trial: define the safe dose of infusional 5-FU in combination with Cetuximab and RT in this setting Phase II part of the trial: Assessment of the pathological complete response (pCR);Secondary Objective: Assessment of treatment related toxicities Assessment of the frequency of sphincter-preserving surgery Assessment of R0-resection rate Assessment of overall pathological response rate (pCR + pPR) Assessment of Recurrence of disease in FU E.;Primary end point(s): Within the phase I part of the trial, the Dose-Limiting Toxicity is the primary safety parameter. For quantification of efficacy within the second part of the trial, the primary objective is the pathological response, defined as complete response as determined by the pathologist at surgery.;Timepoint(s) of evaluation of this end point: DLT are assessed from treatment start (day 1) until 10 days following completion of radiochemotherapy (= day 48). For quantification of efficacy within the second part of the trial, the primary objective is the pathological response, defined as complete response as determined by the pathologist at surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Assessment of treatment related toxicities Assessment of the frequency of sphincter-preserving surgery Assessment of R0-resection rate Assessment of overall pathological response rate (pCR + pPR) Assessment of Recurrence of disease in FU;Timepoint(s) of evaluation of this end point: Treatment phase and / or Follow-Up phase | — |
Countries
Germany
Contacts
Public ContactDr. Robert Semrau
University of Cologne
Outcome results
None listed