Induction Chemotherapy Before or After Preoperative Chemoradiotherapy and Surgery for Locally Advanced Rectal Cancer

Exclusion Criteria

• •Lower border of the tumor localised more than 12 cm from the anocutaneous line as measured by rigid rectoscopy
• •Distant metastases (to be excluded by CT scan of the thorax and abdomen)
• •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).
• •On-treatment participation in a clinical study in the period 30 days prior to inclusion
• •Previous or current drug abuse
• •Concomitant other antineoplastic therapy
• •Serious concurrent diseases, including neurologic or psychiatric disorders (incl. dementia and uncontrolled seizures), active, uncontrolled infections, active, disseminated coagulation disorder
• •Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 6 months before enrolment
• •Chronic diarrhea (\> grade 1 according NCI CTCAE)
• •Prior or concurrent malignancy ≤ 3 years prior to enrolment in study (Exception: non-melanoma skin cancer or cervical carcinoma FIGO (International Federation of Gynecology and Obstetrics) stage 0-1), if the patient is continuously disease-free
• •Known allergic reactions on study medication
• •Known dihydropyrimidine dehydrogenase deficiency
• •Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule (these conditions should be discussed with the patient before registration in the trial)