Panitumumab in Combination With Radiotherapy in Patients With Locally Advanced RAS Wildtype Rectal Cancer (Clinical Stages II and III)

Exclusion Criteria

• •Lower border of the tumor localised more than 12 cm ab ano as measured by rigid rectoscopy
• •Distant metastases (to be excluded by CT scan of the thorax and abdomen)
• •cT4 tumor (as determined by MRI and/or endorectal ultrasound)
• •Risk of tumor involvement of the circumferential resection margin, according to the MRI assessment
• •Sphincter sparing is the major reason for choosing the neoadjuvant treatment approach
• •Prior antineoplastic therapy for rectal cancer
• •Prior radiotherapy of the pelvic region
• •Major surgery within the last 4 weeks prior to inclusion
• •Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment
• •Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly)
• •Serious concurrent diseases
• •On-treatment participation in a clinical study in the period 30 days prior to inclusion
• •Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrolment
• •History of interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
• •History of HIV infection
• •Prior or concurrent malignancy (≤ 5 years prior to enrolment in study) except non-melanoma skin cancer or cervical carcinoma FIGO stage 0-1 if the patient is continuously disease-free
• •Known allergic reactions on study medication