Organ Preservation in Locally Advanced Rectal Cancer by Radiochemotherapy Followed by Consolidation Chemotherapy.

Exclusion Criteria

• •Lower border of the tumor localised more than 12 cm from the anocutaneous line as measured by rigid rectoscopy
• •cT4 tumors
• •Positive lateral pelvic lymph nodes
• •Distant metastases (to be excluded by CT scan of the thorax and abdomen)
• •Preexisting fecal incontinence for solid stool
• •Preexisting peripheral sensory neuropathy with functional impairment
• •Preexisting myelosuppression reflected by a neutrophil count \< 2.000/mm\^3 and/or platelets \< 100.000/mm\^3
• •Severe impairment of kidney function with a Creatinin Clearance \< 30 ml/min)
• •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 according to the "Clinical trial fertility group"
• •On-treatment participation in an interventional clinical study in the period 30 days prior to inclusion
• •Previous or current drug abuse
• •Other concomitant antineoplastic therapy
• •Serious concurrent diseases, including neurologic or psychiatric disorders (incl. dementia and uncontrolled seizures), active, uncontrolled infections, active, disseminated coagulation disorder, severe liver function disorders
• •WHO/ECOG Performance Status \> 1
• •Clinically significant cardiovascular disease (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 stage 0-1), if the patient is continuously disease-free
• •Known allergic reactions on study medication
• •Known dihydropyrimidine dehydrogenase deficiency
• •Medication inhibitors of the dihydropyrimidine dehydrogenase, such as Brivudin, Sorivudin and its analogues.
• •Pernicious anemia or other anemias caused by Vitamin B-12 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).
• •Additionally for hyperthermia cardiac pacemakers and metal implants in the proximity of the pelvis constitute a criterion for exclusion.