Organ preservation in locally advanced rectal cancer by radiochemotherapy followed by consolidation chemotherapy. A prospective phase II pilot trial of the German Rectal Cancer Study Group

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• Lower border of the tumor localised more than 12 cm from theanocutaneous line as measured by rigid rectoscopy cT4 tumors Positive lateral pelvic lymph nodes (s. SOP MRI) Distant metastases (to be excluded by CT scan of the thorax andabdomen) Preexisting fecal incontince for solid stool Preexisting peripheral sensory neuropathy with functional impairment Preexisting myelosuppression refleted by a neutrophil count < 2.000/mm^3and/or platelets < 100.000/mm^3 Severe impairment of kidney function with a Creatinin Clearance < 30ml/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 within6 months after the end of treatment. Subject (male or female) is not willing to use highly effective methods ofcontraception according to the “Clinical trial fertility group”recommendations(http://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf) during treatment and for 6 months (male or female) after the end oftreatment (adequate: combined hormonal contraception associated withinhibition of ovulation, progestogen-only hormonal contraceptionassociated with inhibition of ovulation, intrauterine device, intrauterinehormone-releasoing system, bilateral tubal occlusion, vasectomizedpartner1, sexual abstinence2). On-treatment participation in an interventional clinical study in the period 30days 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 uncontrolledcardiac 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 stage0-1), if the patient is continuously disease-free Known allergic reactions on study medication Known dihydropyrimidine dehydrogenase deficiency Medication inhibitors of the dihydropyrimidine dehydrogenase, such asBrivudin, Sorivudin and its analogues. Pernicious anemia or other anemias caused by Vitamin B-12 deficiency. Psychological, familial, sociological or geographical condition potentiallyhampering compliance with the study protocol and follow-up schedule(these conditions should be discussed with the patient before registration inthe trial). Additionally for hyperthermia cardiac pacemakers and metal implants in theproximity of the pelvis constitute a criterion for exclusion