Prospective randomised multicenter phase-III-study:

INTERVENTION: Product Name: Oxaliplatin Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: Oxaliplatin CAS Number: 61825‐94‐3 Product Name: 5‐Fluorouracil Pharmaceutical Form: Solution for infusion INN or Proposed INN: 5‐Fluorouracil CAS Number: 51‐21‐8 Product Name: Calciumfolinat 5 H2O Pharmaceutical Form: Solution for infusion INN or Proposed INN: Calciumfolinat 5 H2O CAS Number: 7789‐75‐5 CONDITION: Male or femal patients suffering from histologically proven carcinoma of the rectum (tumor = 12cm from the anal verge, with clinically staged T3/4 or any node‐positive disease ; MedDRA version: 8.1 Level: HLT Classification code 10038039 Term: Rectal neoplasms malignant PRIMARY OUTCOME: Main Objective: To investigate whether the addition of oxaliplatin to preoperative fluoropyrimidine‐based chemoradiation and postoperative fluoropyrimidine‐based chemotherapy improves disease‐free survival in locally advances rectal cancer (UICC stage II and III) Primary end point(s): Disease free survival at 3 years defined as the interval from randomization to locoregional or metastatic recurrence or the appearance of a secondary colorectal cancer or death, whichever occurs first. Secondary Objective: • Resectionrate (R0, R1, R2); • Rate of sphincter preservation; • Tumorregression ; • Cumulative incidence of local and distant recurrences; • Overall survival ; • Akute and long‐term toxicity; • Quality of life ; INCLUSION CRITERIA: 1. Age = 18 years 2. Histologically proven, advanced primary carcinoma of the rectum (tumor = 12cm from the anal verge, with clinically staged T3/4 or any node‐positive disease 3. No prior therapy except a diverting stoma 4. ECOG PS = 2 5. Adequate bone marrow function: Leukocytes > 3,5 x 10^9/L Absolute neutrophil count > 1,5 x 10^9/L Platelet count > 100 x 10^9/L Hemoglobin > 10 g/dl 6. Adequate hepatic function: Total bilirubin < 2,0 mg/dl ALAT, ASAT, alkaline phosphatase, gamma‐GT < 3 x ULN 7. Serum creatinine < 1,5 mg/dl, creatinine‐clearance > 50 ml/min 8. Written informed consent before randomization 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