Translational Validation Study to Examine KFO179-1 Biomarker Scores for the Prediction and Prognosis of Advanced Primary Resectable Rectal Cancer Stages UICC-II-IV, With a 5-Fluorouracil-based Standard Radiochemotherapy Followed by Total Mesorectal Excision.

Inclusion Criteria: * Aged 18 to 85 years, inclusive * Histologically confirmed advanced primary rectal cancer localized up to 12 cm above the anocutaneous line (determined with a rigid rectoscope), classified as T3/T4 or N+ carcinomas or with evidence for synchronous, but resectable distant metastases (liver or lung metastases) * No specific tumor treatment except colostomy due to tumor stenosis with ileus * World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) status ≤2 * Adequate bone marrow function (WBC \>3.0x10\^9/L, neutrophils \>1.5x10\^9/L, thrombocytes \>100x10\^9/L, hemoglobin ≥10 g/dl) * Adequate liver function (bilirubin ≤2.0 mg/dl, SGOT, SGPT, AP, gamma-GT \< three point five fold of upper level of normal range * serum creatinine \< 1.5 mg/dl * Written and signed informed consent indicating the understanding of the investigational nature and the study protocol. Exclusion Criteria: * Pregnant or lactating women * Men and women unwilling or unable to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment * Prolonged drug, medication or alcohol abuse * Previous chemotherapy (up to 2 years before diagnosis of rectal cancer) * Previous radiotherapy to the pelvic area * Simultaneous therapy with other anti-cancer drugs * Participation in a clinical trial in the period 30 days prior to inclusion * Patients (man and woman) who are not able or willing …